Dr Reddy's hopes to launch balaglitazone in US, Europe in two years

Dr Reddy's Laboratories Ltd hopes to launch its oral anti-diabetic drug balaglitazone(DRF2593-307), currently under phase III trial, within the next two years, targeting the patients in the US and Europe.

The phase III trials started in Europe in July with a target of 50,000 subjects and the drug would be launched as soon as possible, said Dr Raj Kumar, president of R&D and Commercialisation. The Indian company has tied up with Rheoscience for this insulin sensitizer that acts as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist.

Balaglitazone, fully developed from ground zero by Reddy's, is a second generation of PPAR gamma agonist with only partial agonistic properties, which in clinical phase II studies have shown to have glucose lowering capabilities and to be body-weight neutral. In preclinical experiments, balaglitazone has been shown to cause less fluid retention than full PPAR gamma agonists.

Dr Raj Kumar, while briefing on R&D programmes to the visiting mediamen, said the company was open to all options including developing NCEs at its own and going with partners to further improve the already discovered molecules.

"Our focus area will be metabolic disorders and thrust is being given to NCE discoveries by the company in the coming times,'' Dr Raj Kumar said. The pipeline molecules include therapeutic areas of metabolic, cancer and cardiovascular disorders.

DRL 16536 (AMPL Activator) is in the pre-clinical stage while DRF10945, another PPAR in the metabolic area, is in the second phase of trials. RUS 3108, targeting cardiovascular disorders as perlecan inducer is in the phase I stage of trials while DRF 1042 in the therapeutic area of cancer is in the pre-clinical stage.

Balaglitazone is being developed under a co-development agreement between the company and Rheoscience. Rheoscience will retain the marketing rights to European Union and China and the company will retain the marketing rights in the territories of United States and rest of the world. Rheoscience shall obtain all necessary regulatory approvals on behalf of the company in the United States.

Jubilant Organosys consolidated net surges by over 40%

Jubilant Organosys Ltd (JOL), an integrated pharmaceutical industry player and major CRAMS provider in India, has posted strong performance during the third quarter ended December 2007. The company's consolidated net profit increased by 40.3 per cent to Rs 89.4 crore from Rs 63.7 crore in the corresponding period of last year. It's consolidated net sales increased by 36.7 per cent to Rs 641.6 crore from Rs 469.3 crore. With better growth in profits, its earning per share moved up to Rs 6.22 from Rs 4.45 in the last period. The contribution of pharmaceutical segment increased to 62 per cent in total sales during the quarter under review from 49 per cent in the last period. The pharma division recorded net sales of Rs 397.8 crore as against Rs 229.2 crore in the corresponding period of last year. CRAMS sales increased to Rs 342.8 crore from RS 173.3 crore, a growth of 97.8 per cent in third quarter of 2007-08. This includes sales of recently acquired Hollister-Stier of Rs 81.1 crore. The company's export revenue increased by 63.8 per cent to Rs 346.20 crore from Rs 211.40 crore in the corresponding quarter of last year. Commenting on the company's working, Shyam S Bhartia, chairman and managing director, said, "Third quarter results registered a strong growth, which is in continuance of trends witnessed through the first and second quarter. This was possible through spectacular growth in CRAMS and we see more such growth accruing to our business going forward based on improved capacities, new launches and long term contracts. Given the traction we are witnessing from our key customers for their outsourcing requirements of products and services, we remain confident on delivering a healthy increase in revenues and expansion in operating profit margins going forward". For the nine months ended December 2007, JOL has achieved net profit growth of 108.5 per cent to Rs 342.3 crore from RS 164.2 crore in the last period. Its net sales moved up by 33.7 per cent to Rs 1799.9 crore from Rs 1246.4 crore. Revenues from international operations increased by 53.8 per cent to Rs 951.1 crore from Rs 618.3 crore mainly due to noticeable contributions from the regulated markets and China.

Somaxon Pharmaceuticals Submits New Drug Application for Silenor for the Treatment of Insomnia

Jan 31, 2008 - Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR(TM) (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR(TM) for the treatment of insomnia.

Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the PDUFA guidelines it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA, or in December 2008.

"The completion and submission of our NDA for SILENOR(TM) represents a significant milestone for Somaxon," said David F. Hale, Somaxon's executive chairman and interim chief executive officer. "It is the culmination of a thorough development program that includes six well controlled clinical trials, all of which met their primary endpoints, and multiple non-clinical studies. We believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program are sufficient to support a determination by the FDA that SILENOR(TM) can be approved for the treatment of insomnia. I would like to thank the team at Somaxon, as well as the many clinicians and experts who worked with us, for their efforts in the design and conduct of the SILENOR(TM) development program and the preparation of this NDA for submission."

Encysive Pharmaceuticals Launches Thelin (Sitaxentan Sodium) in Sweden

Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced the commercial availability of Thelin(r)(1) (sitaxentan sodium(2)) 100 mg tablets in Sweden.

THELIN is approved for the treatment of pulmonary arterial hypertension (PAH) and has received reimbursement approval for use in Sweden. Encysive received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment available for patients with PAH.

THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
"A number of evidence-based treatment options for PAH have been developed in recent years. Sitaxentan provides us with another therapy to tailor and optimize treatment for the individual patient," stated Bjorn Ekmehag, MD, Director of the Pulmonary Hypertension Centre, Lund Sweden.

The EU's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the EU. THELIN has been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy, Belgium, Luxembourg and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.

Orexigen Therapeutics Announces Notice of Allowance for U.S. Patent Extending Exclusivity for Composition of Contrave to 2024

(As per the article published in Pharmalive)

Jan 31, 2008 - Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been electronically posted by the United States Patent and Trademark Office (USPTO) for a patent application covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave(TM), Orexigen's lead product candidate for the treatment of obesity, now in Phase III clinical trials. Referred to by the Company as the Weber/Cowley composition patent application, this patent would provide protection for Contrave into the year 2024. This development is an important milestone toward issuance of the patent by the USPTO. Issuance of this patent by the USPTO would extend the Company's exclusive rights on this combination in the United States for an additional 11 years beyond its current patent protection.

"This patent, upon issuance, would further strengthen the intellectual property position for this novel, proprietary drug combination," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "As a composition-of-matter patent it would cover all uses and doses of Contrave into 2024."

Contrave is a proprietary fixed dose combination of bupropion SR and the Company's novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they could both initiate and sustain weight loss. The Contrave Phase IIb clinical trial at 48 weeks demonstrated weight loss from baseline body weight that ranged from 8.0% to 10.7% across the three Contrave dosage groups among patients who completed the trial. The Phase III clinical trials of Contrave are expected to be completed by mid-2009 with the filing of a New Drug Application (NDA) with the FDA projected for late 2009.

Teva Introduces Pantoprazole Sodium Delayed-Release Tablets

January 31, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Pantoprazole Sodium Delayed-Release Tablets. This product is AB rated and bioequivalent to Protonix®* Delayed-Release Tablets. Pantoprazole Sodium Delayed-Release Tablets are available in 20 mg and 40 mg strengths, in bottle sizes of 90.

Teva Announces Tentative Approval of Generic Flomax Capsules

Jan 31, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, 0.4 mg. Final approval of this product is expected upon expiry of patent protection for the brand product in October 2009.

Upon final approval, Teva's product will be the AB-rated generic equivalent of Boehringer Ingelheim's Flomax(R) Capsules, a product indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).

The brand product had annual sales of approximately $1.3 billion in the United States for the twelve months that ended September 30, 2007, based on IMS sales data.

Eisai acquires MGI Pharma for $3.9 billion

As earlier reported by us, Eisai Co., Ltd., a research-based human health care (hhc) company, announced the successful completion of its acquisition of MGI Pharma, Inc. for approximately $3.9 billion through a cash tender offer followed by a short-form merger of its acquisition vehicle, Jaguar Acquisition Corp. (Jaguar), with and into MGI Pharma. As a result of this acquisition, MGI Pharma becomes a wholly-owned subsidiary of Eisai Corporation of North America.

At the effective time of the merger, all outstanding shares of MGI Pharma common stock not validly tendered and accepted for payment in the tender offer were converted into the right to receive US$41.00 per share in cash (the same price paid in the tender offer), without interest and subject to applicable withholding of taxes. Computer share, acting as the paying agent for the merger, will mail to the remaining former shareholders of MGI Pharma materials necessary to exchange their former MGI Pharma shares for such payment. As a result of the merger, MGI Pharma shares will be delisted and cease to trade on the NASDAQ National Market.

Warning Letters issued by FDA

The Food and Drug Administration issued a warning letter to Replidyne, Inc. regarding the company's role as applicant of a marketing application in support of an unnamed drug.

The FDA has posted to its a website a warning letter sent to Novartis Vaccines and Diagnostics Gmbh & Co. KG.

FDA Grants Priority Review For Velcade (bortezomib) for Injection In Patients with Newly Diagnosed Multiple Myeloma

January 30, 2008 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted priority review for VELCADE in patients with newly diagnosed multiple myeloma (MM). The supplemental New Drug Application (sNDA) submitted to the FDA for this indication included data from the Phase III VISTA(1) study, a large, well-controlled international clinical trial, comparing a VELCADE based regimen to a traditional standard of care. VELCADE is the market-leader for MM and mantle cell lymphoma patients who have received at least one prior therapy.

"Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The rapid action by the FDA puts us one step closer to establishing VELCADE based therapies as a standard of care for patients with newly diagnosed multiple myeloma."

Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from ten to six months.

The VISTA trial randomized 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by the Company and its co- development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. The trial compared VELCADE, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation-negative CR rate of 35 percent, which is the highest rate reported in a Phase III trial in patients with newly diagnosed MM, compared to 5 percent in the MP arm.

IMPAX Receives FDA Non-Approvable Letter for Vadova; Company Considering Options

Jan 30, 2008 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application (NDA) and subsequent submissions for Vadova(R) (carbidopa/levodopa extended release) tablets. The FDA's action was primarily based on unresolved issues relating to product nomenclature and its belief of a likelihood of medication errors resulting from confusion of Vadova with other marketed forms of carbidopa/levodopa. The NDA, which was originally filed in April 2005, was deemed non-approvable in March 2006. IMPAX subsequently filed responses addressing the FDA's earlier concerns, which included clinical pharmacology and chemistry, manufacturing and control components. These concerns were not cited in the most recent non-approvable letter.

"We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson's disease," said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product."

Iroko Pharmaceuticals Acquires Rights to Cardiovascular Product from Merck & Co., Inc.

Jan 30, 2008 - Iroko Pharmaceuticals announces the acquisition of all non-US commercial rights to Aggrastat(R) (tirofiban HCl) from Merck & Co., Inc.

Outside of the US market, Aggrastat(R) in combination with heparin is indicated for patients with unstable angina or non-Q wave myocardial infarction to prevent cardiac ischemic events, and is also indicated for patients with coronary ischemic syndromes undergoing coronary angioplasty or atherectomy to prevent cardiac ischemic complications related to abrupt closure of the treated coronary artery. Aggrastat(R) is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing percutaneous transluminal coronary angioplasty (PTCA).

New Patent Awarded for Antigen-Sparing Vaccines that Elicit Robust Immunity

A needle-free vaccine platform that elicits a robust immune response against a wide array of viruses and bacteria has been awarded a U.S. patent. The University of Michigan holds the patent and NanoBio Corporation, a spin-off from the university, licenses the patent and its associated technology.

The intranasal vaccines, produced using NanoBio's nanoemulsion technology, have elicited a dramatic immune response in animals vaccinated against influenza, anthrax, hepatitis B and other diseases. In some cases, the immune response is exponentially higher than what is required to provide adequate protection against infection. Such dramatic levels of immunity would confer significantly higher levels of protection to the vaccinated population at large compared with current injectable vaccines.

Because the vaccines trigger such robust immunity, scientists anticipate they will be able to reduce vaccine antigen quantities to a fraction of what current vaccines require, while still mounting an overwhelming immune response.

This "antigen-sparing" capability would enable scientists to rapidly produce large quantities of vaccines using miniscule amounts of antigen, a critical factor when faced with a disease pandemic or biological warfare.

CIS-US Announces Approval of Generic version of Choletec Kit for the Preparation of Technetium Tc-99m Mebrofenin

Jan 30, 2008 - CIS-US, Inc. announced today that it has received approval from the U. S. Food and Drug Administration (FDA) Office of Generic Drugs for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic Kit for the Preparation of Technetium Tc-99m Mebrofenin. The company will begin distribution the week of February 4.

The Kit for the Preparation of Technetium Tc-99 Mebrofenin is the second agent in the CIS-US product line approved with an indication for hepatobiliary imaging.

Jeanne A. Fiore, VP Regulatory Affair and Quality Assurance, stated, "We are pleased to receive approval of our first ANDA filing and the first generic approval for a Kit for the Preparation of Technetium Tc-99 Mebrofenin."

Glenn Alto, President and CEO of CIS-US stated, "Our approval of the Kit for the Preparation of Technetium Tc-99 Mebrofenin is a gratifying start to the expansion of our existing molecular imaging agent product line. Our commitment to the development, production and supply of key products to nuclear medicine practitioners and their patients will be evidenced as we continue to grow our product offerings in the coming months."

Caraco Pharmaceutical Laboratories Ltd. to Market Generic Protonix

Caraco Pharmaceutical Laboratories, Ltd. announced today that it has launched Pantoprazole Sodium Delayed-Release Tablets, 40 mg (Pantoprazole Sodium DR), which is AB-rated to Wyeth's Protonix(R) DR Tablets, on behalf of Sun Pharmaceutical Industries, Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Protonix(R), and being one of the first-to-file an ANDA with a Paragraph IV certification, shares a 180-day marketing exclusivity with Teva Pharmaceutical Industries Ltd.

Caraco's launch on behalf of Sun Pharma was initiated after the December 22, 2007 launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium DR tablet products, and after the January 29, 2008 launch by Wyeth of generic Pantoprazole Sodium DR tablets product through its designated distributor.
Sun Pharma is currently involved in patent litigation with Wyeth and Altana (recently acquired by Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.

Pantoprazole Sodium DR is indicated for the short-term treatment (up to eight weeks) in the healing and symptomatic relief of erosive esophagitis, is indicated for the maintenance of healing erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD), and is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger- Ellison syndrome. This new product is bioequivalent to Protonix(R), a registered trademark of Wyeth Pharmaceuticals Inc. Protonix(R) 40 mg tablets had U.S. sales of approximately $2.3 billion for the 12-month period ended September 30, 2007, according to IMS Data.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Prasco to Distribute Wyeth's Own Generic Versions of Protonix Delayed-Release Tablets

January 30, 2008 /PRNewswire/ -- Prasco announced today that, pursuant to an agreement it entered into with the ESI Lederle Division of Wyeth ("ESI"), it is shipping the generic version of PROTONIX(R) (Pantoprazole Sodium) Delayed-Release Tablets being offered for sale by ESI. Prasco, as ESI's agent and on ESI's behalf, will solicit orders for and distribute the 20 mg and 40 mg formulations of Pantoprazole Sodium Delayed-Release (DR) Tablets to all trade classes in the U.S. under the ESI Lederle label. Pantoprazole Sodium DR Tablets are AB-rated, therapeutically equivalent and substitutable for the brand PROTONIX Delayed-Release (DR) Tablets.

"We are extremely pleased to have established this agreement with Wyeth, a global leader in the pharmaceutical industry," said Prasco Chief Executive Officer E. Thomas Arington. "Pantoprazole Sodium DR Tablets are identical to PROTONIX DR Tablets, providing the consuming marketplace the benefits of competitive balance and brand-quality at generic prices," stated Arington.

PROTONIX DR Tablets had reported sales of $2.5 billion dollars in the United States, with over 19 million prescriptions filled for the twelve months ended November 30, 2007, based on IMS sales data. PROTONIX is a registered trademark of Wyeth Pharmaceuticals, Inc.

Sun Pharma Launches Generic Protonix Tablets

MUMBAI, India, January 30, 2008-Sun Pharmaceutical Industries Ltd. announced today that it has commercially launched generic Pantoprazole Sodium Delayed Release (DR) Tablets, 40 mg, which is AB-rated to Wyeth's Protonix® DR Tablets. Sun's product is being sold in the United States by its marketing partner Caraco Pharmaceutical Laboratories. Sun Pharma had received a USFDA approval for these tablets in Sep 2007. This strength of Pantoprazole Sodium has annual sales of approximately USD 2.3 billion in the US.

Sun's launch was initiated after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic Pantoprazole Sodium tablets product through its designated distributor.

Sun shares a 180-day period of marketing exclusivity with Teva for this product. Sun is currently involved in patent litigation with Wyeth and Altana (now Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.

Tentative Approval of Generic Lamivudine for Pepfar

Jan. 29, 2008- On January 29, 2008, the FDA granted tentative approval for generic lamivudine tablets, 150 mg and 300 mg, manufactured by Hetero Drugs Limited, Hyderabad, India, for use in combination with other antiretrovirals in the treatment of HIV infection.

"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it is not yet eligible to be marketed in the U.S. because of existing patents and/or exclusivity rights. However, this tentative approval does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR [ http://www.pepfar.gov/ ]) program.

This is a generic version of Epivir, manufactured by GlaxoSmithKline, which is subject to existing patent protection.

Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book [ http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020564&TABLE1=OB_Rx ]"

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Wyeth Announces Launch of Own Generic Version of Protonix

January 29, 2008 /PRNewswire-FirstCall/ -- Wyeth and its business partner, Nycomed, today announced the U.S. launch of Wyeth's own generic version of PROTONIX(R) tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharmaceuticals USA, Inc. on December 21, 2007. Wyeth's own generic version of PROTONIX will be distributed by Prasco starting today.

"Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients," says Bernard Poussot, President and Chief Executive Officer for Wyeth. "We believe the PROTONIX compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva."

Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until August 2, 2007, and Sun's ANDA until September 8, 2007. On September 6, 2007, The United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for preliminary injunction. The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction. Trial is expected in the second half of 2008.

Teva Announces Wyeth Voids Standstill Agreement on Generic Protonix

Jan 29, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the Company's standstill agreement with Wyeth/Altana regarding additional shipments by Teva of generic Protonix (Pantoprazole Sodium) has terminated as a result of Wyeth's launch of an authorized generic product.

Teva is currently involved in patent litigation with Wyeth/Altana concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.

In September 2007, the District Court denied a motion filed by Wyeth/Altana for a preliminary injunction related to Teva's Pantoprazole Tablets. In that decision, the Court found that Wyeth/Altana did not meet its burden of proving likelihood of success on the merits. Wyeth/Altana have appealed that decision.

Akorn, Inc. Announces FDA Approval of Calcitriol Injection, 1 mcg/mL and 2 mcg/mL

Jan 30, 2008 - Akorn, Inc. (NASDAQ:AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Calcitriol Injection, 1 mcg/mL and 2 mcg/mL.

Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It significantly reduces elevated levels of parathyroid hormone. Annual sales for Calcitriol were approximately $6 million in 2007, according to IMS sales data.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce the ANDA approval for Calcitriol Injection. This product will be manufactured in our Decatur, IL facility, and represents the second ANDA approval received for this facility in 2008. We expect to be ready to launch Calcitriol Injection in the second half of 2008."

Ipca Lab acquires additional 4.65 % equity of Tonira Pharma

Ipca Laboratories (IPCA) along with Kaygee Investments Pvt Ltd (KIPL) have acquired additional 3,69,450 equity shares of Rs 10/- each representing 4.65 per cent of the paid up equity share capital of Tonira Pharma Ltd. in the price range of Rs 23.85 to Rs 24.60 per share from open market on January 28, 2008.

The company had made a public announcement to the shareholders of Tonira Pharma Ltd for acquiring 23,83,260 fully paid up equity shares of Rs 10/- each at the rate of Rs 29 per share on November 01, 2007.

With this further acquisition, Ipca's holding along with KIPL (PAC) has increased to 15,44,944 fully paid up equity shares of Tonira Pharma Ltd representing 19.45 per cent of its paid up share capital as under.

Pfizer Japan Receives Manufacturing and Marketing Authorization for Champix

Jan 29, 2008 - Pfizer Japan Inc (headquarter in Shibuya-ku, Tokyo; headed by President & Chief Executive Officer, Hiromitsu Iwasaki; and capitalized at Yen 64.8 billion) announced that on January 25, the company received manufacturing and marketing authorization for Champix(R) Tablet 0.5 mg/1mg (varenicline tartrate), a smoking cessation aid for smokers dependent on nicotine.

Champix is Japan's first oral smoking cessation aid developed for smoking cessation treatment. Current 'Nicotine Replacement Therapy' relieves withdrawal symptoms associated with smoking cessation by replacing tobacco with nicotine. Champix brings about a smoking cessation effect as a non-nicotine partial agonist(1) that binds to alpha(4)beta(2) nicotine receptors in the brain with strong affinity.

Champix relieves withdrawal symptoms and tobacco craving associated with smoking cessation by acting as an agonist for alpha(4)beta(2) nicotine receptors in the brain, which are associated with nicotine dependence. At the same time, if a person smokes a cigarette while receiving treatment, Champix acts as an antagonist to inhibit nicotine from binding to alpha(4)beta(2) nicotine receptors, restricting the patient's sense of satisfaction associated with smoking.

In a 12-week, randomized, double-blind, placebo-controlled study in Japanese smokers who wanted to quit smoking, the primary endpoint (the 4 consecutive-week smoking cessation rate between Week 9 and Week 12) was 65.4 percent (85/130 cases) in patients receiving 1mg Champix twice-daily and 39.5 percent in the placebo group (51/129 cases) respectively, showing a statistically significant difference between the two groups.

Many smokers are suffering from nicotine dependence. At the same time, many smokers who desire and attempt to quit smoking end up without cessation.(2) Nicotine dependence is a chronic disease that is difficult to overcome solely with a smoker's willpower. To successfully quit smoking, a combination of medical support and medication is effective. Pfizer Japan believes that by introducing Champix, we will be able to help many nicotine dependent smokers quit smoking successfully, thus creating a healthier environment in Japan.

Champix was launched under the product name of Chantix(R) in August 2006 in the United States and of Champix(R) in December 2006 in European Union. At present, the product is approved in more than 60 countries around the world, and used for smokers who want to quit smoking. In Japan, it was filed for approval by the Ministry of Health, Labor and Welfare (MHLW) in June 2006 and it was approved on January 25, 2008.

FDA Approves Emend (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy

Jan 29, 2008 - Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EMEND(R) (fosaprepitant dimeglumine) for Injection, a new intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV). EMEND for Injection is an intravenous prodrug of the oral formulation of EMEND(R) (aprepitant), which means that when EMEND for Injection is administered, fosaprepitant is rapidly converted in the body to aprepitant. EMEND for Injection is approved for use in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic and highly emetogenic cancer chemotherapy, including high-dose cisplatin.

EMEND for Injection (115 mg) provides a new option for patients receiving an antiemetic on Day 1 of their chemotherapy. EMEND for Injection (115 mg) may be substituted for the 125 mg oral capsule of EMEND on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. The three-day antiemetic regimen includes EMEND for Injection (115 mg) or EMEND (125 mg orally) on Day 1; EMEND (80 mg orally) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist.

"Nausea and vomiting are among the top concerns that people have when they receive chemotherapy and, to an oncologist, are very important to control," said Lee Schwartzberg, M.D., clinical oncologist and professor of medicine at the University of Tennessee Health Science Center. "While the oral formulation of EMEND is appropriate for many patients, the approval of EMEND for Injection provides healthcare professionals and their patients with a new option in helping to prevent nausea and vomiting caused by chemotherapy."

The FDA approval for EMEND for Injection was based on a study that showed 115 mg of intravenous EMEND for Injection was biologically equivalent to 125 mg of oral EMEND. Adverse events reported in the study, regardless of causality, included infusion site pain (7.6 percent), infusion site induration (1.5 percent) and headache (3 percent). Because EMEND for Injection is converted to aprepitant, common side effects observed with oral EMEND might also be expected to occur with EMEND for Injection, including tiredness, nausea, hiccups, constipation, diarrhea, loss of appetite, headache and hair loss.

EntreMed begins phase II study of ovarian cancer drug

EntreMed, Inc, a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, has initiated a phase II study with its novel cell cycle inhibitor, MKC-1, in recurrent or resistant epithelial ovarian cancer and advanced endometrial cancer patients.

The primary objective of this phase II study will be to determine the antitumour activity of MKC-1 administered orally as a single agent in platinum or taxane refractory ovarian and endometrial cancer patients. In addition, safety, response duration in patients with an objective response, and progression free survival (PFS) will also be assessed. The study will be a two arm parallel group design with each group having two stages.

MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumour cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumour effects, showing tumour growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models.

MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis. Furthermore, MKC-1 inhibits the Akt-mTOR signalling pathways, which may occur through inhibition of the mTOR/rictor pathway. The Akt-mTOR pathway is the most frequently mutated pathway in human tumours and mutations have been shown to promote tumour progression and decrease survival in cancer patients.

The study will be conducted at multiple sites in Canada with Dr. Amit Oza, Senior Staff Physician and Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, serving as the principal investigator.

Commencement of this phase II multi-centre study represents the continuation of our focus on the development of MKC-1 in diseases where, based on its mechanism of action, we would expect activity," commented Carolyn F. Sidor, M.D., M.B.A., vice president and chief medical officer, EntreMed. "We now have five clinical trials underway to test the safety and efficacy of MKC-1 in solid and haematological cancers, including two clinical development programs in Canada. We expect to invest in further clinical trials during 2008 to test the extent of MKC-1's clinical utility in multiple tumour types.

"Ovarian cancer accounts for 4 per cent of all cancers among women in the United States, and ranks fifth as the cause of cancer deaths. The American Cancer Society estimates that there will be approximately 22,000 newly diagnosed cases of ovarian cancer in the US in 2007 resulting in approximately 15,000 deaths. Whereas, endometrial cancer, the most common cancer found in women's reproductive organs, starts in the inner lining of the uterus (endometrium). The American Cancer Society estimates that there will be approximately 39,000 new cases of cancer of the uterine body diagnosed in the US in 2007, resulting in approximately 7,400 deaths.

First and Only Once-Daily Mesalamine for Active, Mild to Moderate Ulcerative Colitis Now Available in Canada

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced the availability in Canada of Mezavant(R)* (mesalamine delayed and extended release tablets) with Multi Matrix System (MMX(TM)(xx)) Technology, indicated for the induction of clinical and endoscopic remission in patients with active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel disease. Mezavant is the first and only Health Canada approved once-daily oral formulation of mesalamine, and the first mesalamine to be approved by Health Canada for the induction of clinical and endoscopic remission.

MEZAVANT is the only ulcerative colitis treatment that utilizes MMX Technology, which combines a pH dependent gastro-resistant coating, thus delaying and extending the delivery of effective concentrations of mesalamine to the site of inflammation in the colon over an extended period of time (from six hours after dosing to beyond 24 hours post-dose). It is available by prescription for oral administration in dosages of 2.4g/day to 4.8g/day, allowing patients to take as few as two tablets, once-daily. Other currently available mesalamines require two to four times daily dosing and up to eight pills a day.

In a chronic, life-long disease such as ulcerative colitis, complex therapy regimens make it difficult for a patient to strictly adhere to therapy, often leading to non-compliance. Two North American Internet surveys(1) conducted with ulcerative colitis patients (n equals 451) and gastroenterologists (n equals 300) reflected this difficulty of adherence with current 5-ASA therapy. Both patients and gastroenterologists reported that managing UC medication is a struggle for patients (49 per cent and 41 per cent respectively) and that it is difficult for patients to take medication as prescribed every day (42 per cent and 90 per cent respectively). This difficulty is further exemplified by the fact that 46 per cent of patients reported not taking all of their medication in the past week.

"The more complicated and varied a dosing regimen is for a patient, the less likely they are to strictly adhere to it, leading to reduced efficacy and ultimately sub-par disease control and low quality of life," states Dr. A. Hillary Steinhart, Head, Combined Division of Gastroenterology, Mt. Sinai Hospital and the University Health Network, Toronto, Ontario. "The availability of Mezavant, with its convenient once-daily dosing, will go a long way in helping address the compliance issues facing Canadian ulcerative colitis patients, allowing them to overcome the disruptions to their life that can be caused by their disease."

"Although not everyone's experience is the same, my complicated pill schedule seems to consume my life - my next dosage is constantly on my mind, and I still occasionally forget a dose" says James Mireau, an ulcerative colitis patient from Edmonton, Alberta. "I have enough to concern myself with due to my disease; taking my pills once-a-day will certainly make my life easier by allowing me the freedom to focus on the more important things, like family." The approval of MEZAVANT was based on the results of two, three-armed, Phase III clinical studies comparing the efficacy of MEZAVANT 2.4g/day, 4.8g/day and placebo after eight weeks of treatment. The primary efficacy endpoint in both trials was based on a composite endpoint indicative of clinical remission and mucosal healing, the first time a mesalamine trial has included both. Remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) score of less than 1.

The first study(2) assessed the efficacy and safety of MEZAVANT at 2.4g/day given in divided doses twice-daily and at 4.8g/day given once-daily against placebo (n equals 262). At eight weeks, both doses demonstrated statistically significant superiority over placebo in the induction of remission. The second study(3) assessed the efficacy and safety of MEZAVANT 2.4g/day and 4.8g/day, both given once-daily versus placebo (n equals 255). At eight weeks, both once-daily doses demonstrated statistically significant superiority over placebo in the induction of remission. "Effective, safe and convenient therapy options are imperative for gastroenterologists treating ulcerative colitis. Based on the results from its clinical trials, Mezavant will be a welcome addition to our armamentarium to help induce remission in ulcerative colitis patients," adds Dr. Steinhart.

Important Safety Information

MEZAVANT is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate. In clinical trials (n equals 535), the most common treatment-related adverse events with MEZAVANT were headache and flatulence.

Johnson and Johnson submits NDA for tapentadol

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tapentadol hydrochloride immediate release (IR) tablets, an investigational oral analgesic for the relief of moderate to severe acute pain.

Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.

According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 per cent of US hospital emergency department visits were due to pain-related problems.

Mu-opioid agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.

The submission is based on a full clinical development program for tapentadol. The program includes two phase III multi-centre studies that explored the efficacy and safety of multiple doses of the tapentadol IR formulation either for the treatment of acute pain in patients undergoing bunionectomy surgery or for patients with degenerative, end-stage joint disease of the hip or knee. The data from these clinical trials suggest that tapentadol has efficacy comparable to strong opioids.

Bunionectomy is a standard foot surgery. The predictable level of moderate to severe pain for several days following this surgery makes bunionectomy an appropriate model for assessing the efficacy of potent analgesics.

Data also were submitted to the FDA from an additional Phase 3 study that supported the safety profile of multiple doses of tapentadol IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or the knee.

More than 1,800 patients have been treated with tapentadol immediate release tablets in clinical trials to date.The most common adverse reactions in tapentadol phase II/III multiple dose, placebo- and active-controlled efficacy and safety studies (=10 per cent) were nausea, dizziness, vomiting, somnolence (sleepiness) and headache.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is conducting the clinical program for tapentadol in the United States. J&JPRD submitted the new drug application (NDA) for tapentadol on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc., an affiliated company that will hold the NDA for tapentadol.

Oncolytics Biotech Inc. Announces Issuance of 8th Canadian Patent

Oncolytics Biotech Inc. ("Oncolytics") has been granted Canadian Patent 2,408,251 entitled "Clearance of Neoplastic Cells from Mixed Cellular Compositions using Viruses." The claims describe methods of selectively removing cancer cells ex vivo from blood stem cells and other organs using various viruses including modified vaccinia viruses, herpes simplex viruses, parapoxviruses and adenoviruses.

"This patent broadens coverage in the area of using other modified oncolytic viruses to purge contaminating cancer cells from stem cell preparations used for transplants," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.

Generex Biotechnology Awarded New European Patent

Generex Biotechnology Corporation (Nasdaq:GNBT) announced today that the European Patent Office has granted the Company a new European patent, titled "Mixed Micellar Delivery System and Method of Preparation."

The patent will be validated in eleven European countries including the U.K., France and Germany. The patent contains process and formulation claims to a pharmaceutical formulation for delivery through the mucosal membranes.

"We are pleased to continue to expand our patent portfolio in Europe, which is part of the Company's European and global growth strategy," said Rose C. Perri, the Company's Chief Operating Officer.

Generex currently holds an aggregate of 123 patents worldwide (21 of which are United States Patents) and has an aggregate of 92 patent applications pending in various jurisdictions.

China Pharma Holdings, Inc. Receives Chinese SFDA Approval for Generic Bumetanide Injection

China Pharma Holdings, Inc. ("China Pharma") which develops, manufactures, and markets generic and brand bio-pharmaceutical products in China, announced today that it has received approval from the Chinese State Food and Drug Administration (SFDA) for the production of generic Bumetanide injection which is used to manage hypertension and edema associated with congestive heart failure, cirrhosis, and renal disease, including the nephrotic syndrome by inducing dieresis.

Natco gets a stay for Imatinib

As per the article published by Mr. Sandeep Rathod on http://genericpharmaceuticals.blogspot.com/

Natco has received a stay from the Supreme Court against the Chennai High Courts’ order for the IPAB hearing of Novartis’ appeals [for Imatinib] without a technical member.
The Chennai High Court had earlier decided that the IPAB could hear an appeal without a technical member.

Natco had then declared that it would go to the Supreme Court to against this decision for the constitution of the Bench comprising its Chairman and Vice-Chairman to hear the appeals, without a technical member

GSK to revise labelling for Avandia to add new warnings

As per the recommendations made by the European regulators, GlaxoSmithKline (GSK) will revise labelling on its diabetes product Avandia to include additional warnings that the product may be associated with an increased risk of heart attacks.

The label will be revised to state that available data indicate that rosiglitazone may be associated with an increased risk of myocardial ischaemic events. It will also state that this risk was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) completed a positive benefit risk review of the thiazolidinediones (TZDs) including rosiglitazone in October 2007 and these label amendments are the result of this process.

There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease, especially those with myocardial ischaemic symptoms. The revised label will state that as a precaution, the use of rosiglitazone is not recommended in these patients. This information will appear in the warnings and precautions section of the label.

Patients with acute coronary syndrome (unstable angina, NSTEMI and STEMI) require urgent hospital treatment and have an increased risk of developing heart failure. This high-risk patient population has not been studied in rosiglitazone controlled clinical trials, and revised labelling will advise prescribers that rosiglitazone is contraindicated in patients with acute coronary syndrome.

"The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks. The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone," said Dr Alastair Benbow, vice president and European medical director, GSK.

The label changes will be applied to all approved rosiglitazone-containing products: Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride) and Avaglim (rosiglitazone maleate and glimepiride).

"Long-term glycaemic control is important to help prevent the serious complications of diabetes, especially microvascular complications leading to blindness, amputation and kidney failure. Rosiglitazone has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines, metformin and glibenclamide (a sulfonylurea) - for nearly five years. Rosiglitazone is a valuable medicine for many patients with type 2 diabetes and remains an important treatment option for physicians." added Dr Benbow.

Rosiglitazone helps improve blood sugar control in Type 2 diabetes. It may be taken alone by diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin.

Matrix acquires residual holding in MChem, China

Matrix Laboratories Ltd, through its wholly owned subsidiary, has acquired the residual shareholding in MChem group of companies, China. Consequent upon the receipt of the applicable approvals, the transaction for purchase of the residual stake has been completed. With the purchase of the residual stake, the effective holding of the company in MChem group of companies, through its wholly owned subsidiary, stands at 97 per cent.

MChem manufactures a number of intermediates and Active Pharmaceutical Ingredients (APIs). Therefore, the acquisition of the residual stake of erstwhile promoter is strategic for enhancing the vertical integration opportunities for Mylan and Matrix.

Clexane/Lovenox Approved in Japan

Sanofi-aventis announced today that the anticoagulant Clexane(R) (enoxaparin sodium injection) has been approved for marketing in Japan by the Ministry of Health, Labour and Welfare for the prevention of venous thromboembolism (VTE) in patients undergoing orthopaedic surgery of the lower limbs such as total hip replacement, total knee replacement and hip fracture surgery.

Nexavar Approved for the Treatment of Kidney Cancer in Japan

According to the article published in Pharmalive

Bayer has been granted marketing approval of Nexavar® in Japan for the treatment of advanced renall cell carcinoma (RCC), the most common form of kidney cancer. Nexavar is an oral multi-kinase inhibitor jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. which targets both the tumor cell and tumor vasculature. In Japan, Nexavar is the first approved oral targeted therapy for metastatic RCC.

“This approval of Nexavar is a crucial step for patients with advanced kidney cancer in Japan”, said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. “This is also a major accomplishment for the company's oncology franchise in Japan.”

The new drug application (NDA) for Nexavar in RCC was filed in June 2006. In September 2007, an additional application for the treatment of hepatocellular carcinoma (HCC) was filed. Japanese authorities recently granted priority review status for Nexavar in this indication.

Alnylam Announces Grant of New Patent Covering RNAi Therapeutics in the United Kingdom

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United Kingdom Patent Office has granted a patent (UK 2417727 or "'727 patent") for the Woppman et al. patent series, entitled "Double-stranded ribonucleic acid with increased effectiveness in an organism." The newly granted patent includes 32 claims broadly covering compositions and methods, including pharmaceutical compositions, for small interfering RNAs (siRNAs), the molecules that mediate RNAi. The claims cover siRNA molecules of any length that contain "overhang" and "blunt end" design features, including siRNAs containing chemical modifications and certain novel motifs.

"Our intellectual property estate for RNAi therapeutics continues to grow substantially as evidenced by this new patent grant, the first in a distinct patent series that describes important design features for RNAi therapeutics. With this progress, we are extending the scope of our comprehensive 'first-mover' consolidation of early filed RNAi fundamental patents and patent applications," said Barry Greene, President and Chief Operating Officer of Alnylam. "We expect that many additional patents owned or licensed exclusively to Alnylam will be awarded this year and in the years to come, broadening the sphere of our patent portfolio for siRNAs in markets across the world."

Mylan Provides Update Relating to Ongoing Lorazepam and Clorazepate Litigation

Mylan Inc. today announced that it intends to appeal a Jan. 24, 2008 decision by the U.S. District Court for the District of Columbia against Mylan and its co- defendants Cambrex Corporation and Gyma Laboratories in the last of the pending Lorazepam and Clorazepate antitrust cases. The first related suit had been filed in 1998.

As previously disclosed, in June 2005, a jury in the district court had rendered a verdict against Mylan and its co-defendants. The parties subsequently filed various post-trial motions, and the January 24 decision resolved several of those motions. The district court ordered Mylan to pay $35,906,922. The court also ordered Cambrex and Gyma to pay $16,709,242 each, some or all of which may be subject to indemnification obligations by Mylan. Plaintiffs' motion for attorneys' fees remains pending.

Mylan intends to immediately appeal the decision and will continue to vigorously defend itself in the litigation.

Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.

Endo and Penwest File Lawsuit Against Impax Laboratories Relating to Opana ER

CHADDS FORD, PA and DANBURY, CT, Jan 25, 2008 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Inc., a subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that they have filed a lawsuit against Impax Laboratories, Inc. in the United States District Court for the District of Delaware in connection with Impax's Abbreviated New Drug Application (ANDA) for Opana ER (oxymorphone HCl) extended-release tablets CII. The lawsuit is in response to IMPAX's notice to Endo and Penwest, announced on December 17, 2007, advising of the FDA's acceptance for substantive review, as of November 23, 2007, of IMPAX's ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. IMPAX stated in its Paragraph IV certification notice letter that the FDA requested IMPAX to provide notification to Endo and Penwest of this certification.
IMPAX's Paragraph IV certification notice refers to certain Penwest patents listed in the FDA's Orange Book relating to the formulation of OPANA ER. The complaint filed today alleges infringement of certain of these Orange Book-listed patents.

As previously disclosed, Endo and Penwest filed a lawsuit against IMPAX on November 15, 2007 in the United States District Court for the District of Delaware in response to a series of Paragraph IV certification notices that Endo and Penwest assert were wrongfully served on them by IMPAX. These prior Paragraph IV Certification Notices related to the same Orange Book-listed patents for OPANA ER and were served on Endo and Penwest after the acceptance of IMPAX's ANDA was rescinded by the FDA. Endo and Penwest continue to believe that these prior Paragraph IV Certification Notices are null, void and of no legal effect.

OPANA ER has been granted new dosage form regulatory exclusivity that prevents the FDA from approving any ANDA for a generic version of OPANA ER for launch prior to June 22, 2009, the date such regulatory exclusivity expires.

Japan grants priority review status to Bayer's Nexavar

The Japanese health authority (MHLW) has granted Bayer priority review status (fast-track procedure) for marketing authorization of its anticancer drug product Nexavar (sorafenib) for the treatment of hepatocellular carcinoma (HCC). In addition, the contrast agent Primovist (gadoxetic acid disodium) for magnetic resonance imaging of the liver was recently granted regulatory approval in Japan. This product is scheduled to be launched on the Japanese market in the immediate future.

Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.

Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.

"The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase," said Paolo Pucci, president, Global Business Unit Oncology, Bayer HealthCare. "We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types."

Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumours such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.

"Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence", said Professor Hans Maier, Head, Global Business Unit Diagnostic Imaging, Bayer Schering Pharma. "Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit."

Novexel, Forest Labs agreement on NXL104

Novexel, the pharmaceutical company focused on the discovery and development of novel antibacterials and anti-fungals, has entered into an agreement with Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc., for the development, manufacture and commercialization of Novexel's novel intravenous beta lactamase inhibitor, NXL104 in combination with Forest's ceftaroline. NXL104 is designed to be co-administered with select antibiotics to enhance their spectrum of activity.

Under the terms of the license, Forest will receive the exclusive rights to administer NXL104 with ceftaroline as a combination product in North America.

Ceftaroline is a novel, bactericidal injectable broad spectrum cephalosporin being developed as a therapeutic agent for the treatment of gram-positive pathogens including methicillin resistant staphylococcus aureus (MRSA), and multi-drug resistant streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline is being studied as a monotherapy in Phase III clinical trials for complicated skin and skin structure infections and community acquired pneumonia. Forest intends to initiate Phase I studies of the ceftaroline/NXL104 combination in the next fiscal year.

Forest will also receive a first negotiation right in North America to an additional NXL104 combination with ceftazidime, a cephalosporin antibiotic having a different spectrum of activity compared to ceftaroline. This combination is currently being studied in Phase I clinical trials conducted by Novexel. NXL104 inhibits bacterial enzymes called beta-lactamases that break down beta-lactam antibiotics (in particular Penicillins and Cephalosporins). Beta-lactamase inhibition represents a mechanism for counteracting resistance and enhancing broad-spectrum activity of beta-lactam antibiotics. A composition of matter patent which claims NXL104 would provide protection for the ceftaroline/NXL104 combination product until 2022, subject to possible patent term extension.

Under the terms of the agreement, Forest will pay Novexel an upfront license payment of €75 million. Forest will fund development and commercialization of the ceftaroline/NXL104 combination. Additional milestone payments to Novexel if the combination product is successfully developed could total €75 million. Following the product's regulatory marketing approval, Forest will pay Novexel a low double digit royalty on product sales throughout North America.

Cephalon Provides Update on Regulatory Status of the Fentora Supplemental New Drug Application

FRAZER, Pa., January 25, 2008 /PRNewswire-FirstCall/ -- Cephalon, Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] for the management of breakthrough pain in opioid-tolerant patients with chronic pain. In addition, the FDA notified the Company that it will convene an advisory committee panel on May 6, 2008, to consider this application.

"We are pleased that the FENTORA application remains on schedule with an FDA action date of September 13, 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "FENTORA is the first medication that has been evaluated in controlled clinical trials for the management of breakthrough pain in opioid-tolerant patients with chronic pain. Therefore, it is not surprising that the agency decided to convene a panel to consider data on the use of FENTORA beyond the initial indication for breakthrough pain in cancer patients."
Included in the FENTORA sNDA are data from three randomized, placebo- controlled clinical trials and one long-term open-label safety study; including data from opioid-tolerant patients with chronic low back and neuropathic pain. The sNDA provides an evaluation of the onset of pain relief from 10 minutes to two hours, and has information regarding bioequivalence data for two routes of administration.

In 2006, FENTORA and an accompanying Risk Minimization Action Plan (RiskMAP) were approved by the FDA only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. The company developed and maintains a FENTORA RiskMAP to address the appropriate patient selection, dosing and administration of the medication.

ImaRx Therapeutics Receives Urokinase Lot Release Approval With Extended Expiration Dating

TUCSON, Ariz., Jan. 25 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc. today announced that the Food and Drug Administration (FDA) has approved the company's most current lot release request for urokinase drug product. This is the first lot to be released with extended expiration dating. Urokinase, ImaRx's first commercially available FDA-approved product, is a thrombolytic or clot-dissolving agent indicated for the treatment of acute massive pulmonary embolism.

"The FDA approval of urokinase lot release brings several advantages to ImaRx," said Bradford A. Zakes, President and CEO of ImaRx. "The extended expiration dating allows us to unlock the value from our unlabeled urokinase inventory. We will also benefit from cost-savings associated with prolonged shelf-life for future urokinase supplies."

ImaRx is continuing its stability program to evaluate the potential for further expiration extensions beyond September 2009 for unlabeled vials of urokinase inventory.

In January 2008, ImaRx and Microbix Biosystems Inc. signed a letter of intent to manufacture urokinase and explore development of additional indications. Microbix is believed to be the only supplier capable of producing urokinase on a commercial scale at its production facility in Toronto. As part of the agreement, ImaRx will retain existing urokinase inventory and intends to transfer the manufacturing process and NDA to Microbix. With Microbix as its long-term supplier, ImaRx will continue to market urokinase for acute massive pulmonary embolism, while Microbix will have development rights for certain new indications.

Lawsuit Online Signup over Avandia (Rosiglitazone) Side Effects is Announced by the Law Offices of Howard G. Smith

PHILADELPHIA--(BUSINESS WIRE)--Jan 25, 2008 - The Law Offices of Howard G. Smith announces that an online sign up is available for a lawsuit on the behalf of people injured by taking Avandia. The suit will allege that the manufacturer of the drug, GlaxoSmithKline, failed to properly warn patients and their doctors of the known Avandia side effects.

Avandia (rosiglitazone) is a widely prescribed medication used to treat Type-2 Diabetes Mellitus, a condition also known as Adult-Onset Diabetes. On May 21, 2007, the FDA issued a Safety Alert regarding Avandia. The FDA Safety Alert warns that patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should speak to their physicians about their continued use of Avandia (rosiglitazone).

The FDA's Safety Alert follows a study released on the same day. The study concluded that patients taking Avandia face both an increased risk of suffering a heart attack and an increased risk of dying from heart related disease, such as congestive heart failure or CHF.

Cypress Reaches Settlement with Glaxo Group Limited Relating to Ranitidine Oral Syrup Products

MADISON, Miss.--(BUSINESS WIRE)--Jan 25, 2008 - Cypress Pharmaceutical, Inc. today announced that it has reached a settlement with Glaxo Group Limited (Glaxo), part of the GlaxoSmithKline group of companies, resolving all disputes between the companies related to Cypress' generic ranitidine oral solution products and Glaxo's Zantac(R) syrup.

Under the terms of the settlement, Glaxo has agreed not to assert its patent against Cypress' new alcohol-free formulation of its generic ranitidine oral syrup. Cypress expects to launch the product immediately upon receiving FDA approval. As a result of the settlement, the parties filed a stipulation to dismiss their patent litigation pending in the U.S. District Court for the Southern District of New York.

Teva Introduces Oxytocin Injection, USP (Synthetic)

IRVINE, Calif., January 24, 2008 – Teva Health Systems is pleased to announce the introduction and availability of Oxytocin Injection, USP (Synthetic). This product is AP Rated* and available in 10 Units/mL, 10 Units in Single Dose Glass Vials, and 10 Units/mL, 100 Units in Multiple Dose Glass Vials.

“Our generic injectable and unit-dose pharmaceuticals are an economical choice for our health system customers,” states Jonathan Zalk, Director of Marketing. “We continue to add new products to meet the growing demand for quality, affordable alternatives to brand pharmaceuticals.”

Teva Health Systems is a part of Teva Pharmaceuticals, the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research and Development effort and one of the best overall ANDA approval records in the industry.

Forest Laboratories, Inc. and Merz Pharma GmbH & Co. KgaA File Additional Lawsuit Against Several Companies for Patent Infringement

NEW YORK, January 25, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KgaA, and Merz Pharmaceuticals GmbH announced that they have filed a second lawsuit in the U.S. District Court for the District of Delaware against additional companies for infringement of U.S. Patent No. 5,061,703 (the '703 patent), which relates to Forest's Namenda(R) product. The defendants named in the lawsuit include Dr. Reddy's Laboratories Limited, Genpharm Inc., Interpharm Inc., Mylan Pharmaceuticals Inc., Ranbaxy Laboratories Limited, Sun India Pharmaceutical Industries Limited, and related companies and subsidiaries thereof. The '703 patent expires in April 2010. Forest has applied for patent term extension which, if granted, would extend the '703 patent until September 2013.

As previously reported, Forest and Merz had received notification from several companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications to obtain approval to market generic versions of Namenda and commenced an action in patent infringement in the U.S. District Court in Delaware against such filers.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in each of Forest Laboratories' Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

Patent Granted for Hydrate form of Rosiglitazone Maleate

GlaxoSmithKline has received an Indian Patent No. 213203 (the ‘203 patent) for a novel hydrate form of Rosiglitazone Maleate against the mail-box Application No. IN/PCT/2000/00076/MUM filed December 14, 1998 claiming earliest priority from British patent application dated December 16, 1997. The ‘203 patent titled ‘Hydrate of 5-[4-[2-(N-methyl-N-(2-pyridil) amino) ethoxy] benzyl] thiazolidine-2, 4-dione maleic acid salt’ is lately published in the Patent Office Journal Issue No. 04/2008. Abstract of IN/PCT/2000/00076/MUM reads as –

A hydrate of 5-[4-[2-(N-methyl-N-(2-pryidyl) amino) ethoxy] benzyl] thiazolidine-2, 4-dione, maleic acid salt, characterised in that it: (i) contains water in the range of from 0.2 to 1.1% w/w, and (ii) provides an infrared spectrum containing peaks at 764 and 579 cm-1; and/or (iii) provides an X-ray powder diffraction (XRPD) pattern substantially as set out in Figure II; a process for the preparation of such a compound, a pharmaceutical composition containing such a compound and the use of such a compound or composition in medicine.

Rosiglitazone Maleate, globally marketed as Avandia is patented anti-diabetic drug in US and EU valid till October 2015 and September 2014 respectively. Although not sure exactly in what form claims are issued by the Mumbai Patent Office, but certainly would be interested knowing that. For close reference, refer equivalent US Patent Nos. 6,664,278 and 7,045,633.

(Article published in Patent circle by Mr. Varun)

Peregrine receives DCGI approval for phase II trial of Bavituximab

Peregrine Pharmaceuticals, Inc, a clinical stage biopharmaceutical company, has received approval from the Drug Controller General of India (DCGI) to its phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumours, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumour growth and spread. In a phase Ib pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50 per cent of the evaluable patients.

Cadila, Prolong ink pact to develop anaemia drug

Cadila Healthcare Ltd has entered into pact for collaboration for development of a next generation therapeutic protein, 'PEG-EPO', for the treatment of severe anaemia with Prolong Pharmaceuticals Inc., a US-based, venture-backed drug delivery research and development company.

Severe Anaemia is a condition where the haemoglobin (Hb) level or number of circulating red blood cells (RBCs) is significantly reduced. This is common in chronic renal failure (CRF), cancer patients undergoing chemotherapy, some chronic inflammatory diseases, heart failure, surgical settings and critically ill patients. The first generation drug, EPO, did wonders to the treatment of this condition. However, new advances in therapy can improve EPO's therapeutic profile, offer greater convenience, and lower treatment costs. PEG-EPO promises to be a third generation drug.

Speaking on the occasion, Pankaj Patel, chairman and Managing Director Zydus Cadila, mentioned "This deal marks Zydus's foray into the area of novel improved biologicals. There is a strong unmet medical need in this space, and we are committed to discover, develop and provide better as well as safer alternatives to patients at affordable prices".

Bayer Extends Product Portfolio for Liver Cancer Patients in Japan

BERLIN, January 24, 2008 – Bayer is coming closer to its goal of extending its product portfolio for liver cancer patients in Japan to provide a comprehensive range of services from diagnosis to life-prolonging therapies. The Japanese health authority (MHLW) has granted Bayer priority review status (fast-track procedure) for marketing authorization of its anticancer drug product Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma (HCC). In addition, the contrast agent Primovist® (gadoxetic acid disodium) for magnetic resonance imaging of the liver was recently granted regulatory approval in Japan. This product is scheduled to be launched on the Japanese market in the immediate future.

Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.

Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.

“The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase,” said Paolo Pucci, President of Bayer HealthCare’s Global Business Unit Oncology. “We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types.”

Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumors such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.

“Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence“, said Professor Hans Maier, Head of the Global Business Unit Diagnostic Imaging at Bayer Schering Pharma. “Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit.”

FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults

January 24, 2008 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has received approval of its New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA), for its once-daily Moxatag(TM) Tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

The FDA approval was based on results from a Phase 3 clinical study conducted with more than 600 patients that found once-daily MOXATAG for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. MOXATAG was very well tolerated in the clinical trial.

"We are extremely gratified to have received FDA approval of our MOXATAG NDA," stated Edward Rudnic, Ph.D., president and CEO of MiddleBrook. "As the first and only once-daily amoxicillin therapy approved for marketing in the United States, we believe MOXATAG represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat. We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand."

In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further evaluate its MOXATAG product candidate for pediatric patients less than 12 years of age with pharyngitis and/or tonsillitis as part of a post-marketing commitment. The Company has agreed to submit a completed study report and data set for MOXATAG in pediatric patients less than 12 years old within the next five years as part of this commitment.

"Compared to four times daily penicillin, once-daily MOXATAG has shown comparable efficacy and tolerability in eradicating Group A streptococcal infections of the pharynx. However, the once-daily dosing of MOXATAG is a major advantage," said lead study investigator Stan L. Block, M.D., professor of clinical pediatrics at the Universities of Louisville and Kentucky Medical Schools. "For the first time, physicians in the U.S. have the option of an FDA-approved once-daily amoxicillin therapy to treat their adolescent and adult patients with pharyngitis/tonsillitis. This should ensure better first- line therapy compliance with a penicillin class of antibiotic."

New Drug Application Submitted to FDA for Investigational Analgesic Tapentadol Immediate Release Tablets

January 23, 2008 /PRNewswire-USNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol hydrochloride immediate release (IR) tablets, an investigational oral analgesic for the relief of moderate to severe acute pain.

According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems.

Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.

Mu-opioid agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increase the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.

The submission is based on a full clinical development program for tapentadol. The program includes two Phase 3 multi-center studies that explored the efficacy and safety of multiple doses of the tapentadol IR formulation either for the treatment of acute pain in patients undergoing bunionectomy surgery or for patients with degenerative, end-stage joint disease of the hip or knee. The data from these clinical trials suggest that tapentadol has efficacy comparable to strong opioids.

Bunionectomy is a standard foot surgery. The predictable level of moderate to severe pain for several days following this surgery makes bunionectomy an appropriate model for assessing the efficacy of potent analgesics.

Data also were submitted to the FDA from an additional Phase 3 study that supported the safety profile of multiple doses of tapentadol IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or knee.

More than 1,800 patients have been treated with tapentadol IR tablets in clinical trials to date.
The most common adverse reactions in tapentadol Phase 2/3 multiple dose, placebo- and active-controlled efficacy and safety studies (10%) were nausea, dizziness, vomiting, somnolence (sleepiness) and headache.

Navamedic Takes Over Marketing of Glucomed in Sweden, Denmark, Norway and Finland

January 24, 2008- Through its subsidiary Vitaflo Scandinavia AB, Navamedic will take responsibility for the marketing and distribution of Glucomed in Sweden, Denmark, Norway and Finland

Vitaflo has for several years shown a good track record for marketing of pharmaceutical products in the Nordic countries. Through Vitaflo, the company strongly believes that it is in position to take a larger part of the Nordic market for glucosamine products. The change will strengthen Navamedic's position within marketing and distribution of pharmaceuticals in the region, and the change will give a higher gross margin on future sales of Glucomed in these countries.

The change is initiated by Navamedic, as a result of Meda's acquisition of the pharmaceutical company Recip towards the end of 2007. Meda thus became the owner of Glucosine, one of Glucomed's competitors in some of the Nordic markets. The change will be effective from 1 March 2008.

In Q4 2007, Navamedic will state as income the rest of a provision related to a possible regulation of prices on earlier sales of Glucomed to Meda. In Q1 2008, the remaining provisions related to the received license income will be stated as income.

Daiichi's cholesterol drug Welchol gets US FDA approval

Daiichi Sankyo, Inc, said the United States Food and Drug Administration (FDA) has approved its cholesterol drug Welchol (colesevelam HCl) to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C) in adults with type 2 diabetes.

Welchol is now the first and only medication approved to improve glycemic control (measured as haemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents.

The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 per cent of these people having type 2 diabetes. Forty per cent of patients with type 2 diabetes also have high LDL-cholesterol . Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes.

The data from the study demonstrated that Welchol can lower both A1C and LDL-C levels in patients with type 2 diabetes who were uncontrolled on a metformin-based regimen. Patients in the study were randomly assigned to two groups. The addition of Welchol was compared to the addition of placebo in patients on a metformin-based regimen. The addition of Welchol (n=79) to pre-existing metformin monotherapy achieved a significant mean reduction in A1C levels of 0.47 percent relative to placebo (p<0.0024).

"Welchol now offers physicians a treatment option that addresses two major cardiovascular risk factors; elevated LDL cholesterol and blood glucose in patients with type 2 diabetes," said Ronald B. Goldberg, MD, an investigator in the insulin and metformin pivotal studies and Professor of Medicine at the Division of Diabetes and Metabolism and Associate Director of the Diabetes Research Institute at the University of Miami, Miller School of Medicine in Florida. "Cardiovascular risk factors are of great concern because patients with type 2 diabetes have a significantly increased risk of developing cardiovascular disease. Once clinical cardiovascular disease develops, these patients have a poorer prognosis than normoglycemic patients."Since 2000, Welchol, a bile acid sequestrant, has been indicated, alone or in combination with a statin, for the reduction of elevated LDL-C in patients with primary hypercholesterolemia. It is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, Welchol is not expected to have drug interactions via the cytochrome P450 pathway. Systemic medications, which include statins, fibrates and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.

Welchol is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor. Welchol is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Nicholas Piramal buys Healthline's pharma business for Rs 150m

Nicholas Piramal India Ltd and Healthline Pvt. Ltd (HLPL) have signed a definitive agreement for purchase of HLPL's Pharmaceuticals business by the company for a consideration of Rs 150 million.

HLPL has a modern injectables manufacturing unit at Bangalore for small and large volume injectable products. The current facility was commissioned in 2004 and has a capacity of 10 million vials per annum on a single shift basis. The company will invest additional resources at the facility to expand capacity and secure US FDA standards.

Commenting on the acquisition, Ajay Piramal, chairman, of the company said, "NPIL is committed to expand its Custom Manufacturing offering to global customers. HLPL is a good asset, which will expand our high-end manufacturing solutions from India".

Allegro Capital was HLPL's advisors on the transaction.

NovaDel's New Drug Application for ZolpiMist Oral Spray to Treat Insomnia Accepted for Filing by the U.S. Food and Drug Administration

NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for ZolpiMist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines.

NovaDel submitted its ZolpiMist(TM) application using the FDA's 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist(TM) and Ambien(R). Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.

FDA Approves Additional Indication for Astellas’ Mycamine

Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved their Supplemental New Drug Application (sNDA) seeking approval for the use of MYCAMINE® (micafungin sodium) for Injection in the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. MYCAMINE was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.

"The FDA’s approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Executive Officer, Astellas Pharma US, Inc. "The approval of this additional indication is another step toward fulfilling our mission to provide innovative treatments such as MYCAMINE to help patients with significant medical needs."

Suven Obtains 2nd Product Patent from US Patent Office

Suven Life Sciences Ltd announces today that the US Patent office has granted Product Patent # US 7,317,035 to Suven. This is Suven’s second product patent granted in USA. The granted claims of the patent include the class of selective Serotonin receptor affinity compounds discovered by Suven and are being developed as therapeutic agents. According to the invention ‘035 patent disclosure, the compounds are useful in the treatment of neuro-degenarative disorders like Alzheimer’s, Parkinson, Schizophrenia and Huntington’s.

Suven has so far filed 29 product patent applications through PCT covering more than 145 countries, out of which 5 product patents are granted in various countries. There are several other patent applications from Suven Discovery Research are in the pipeline that have completed the administrative and technical diligence from the patent offices from major countries and would be granted shortly.

Suven has filed its first Investigational New Drug (IND) application with DCGI to conduct the clinical Phase-I study on their developmental candidate SUVN-502 and several candidates are in discovery pipeline undergoing GLP pre-clinical studies.

“We are very pleased by the issuance of this patent to Suven by US Patent office for our drug candidates that are being developed for CNS disorders which targets a $18 billion potential market opportunity “ says Venkat Jasti, CEO of Suven.

U.S. Patent Office Rejects Key HIV/AIDS Drug Patents at PUBPAT Request: Government Finds Prior Art Submitted By PUBPAT Invalidates All of Gilead

The Public Patent Foundation ("PUBPAT") announced today that the U.S. Patent & Trademark Office has rejected four key HIV/AIDS drug patents held by Gilead Sciences that relate to the drug known generically as tenofovir disoproxil fumarate (TDF), a key weapon in the battle against HIV/AIDS. Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product.

Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans. The U.S. Food and Drug Administration will not allow anyone other than Gilead distribute TDF in the United States because Gilead claims the four patents challenged by PUBPAT and now rejected by the Patent Office give them the exclusive right to do so.

"Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way," said Dan Ravicher, PUBPAT's Executive Director. "This includes Americans infected with HIV/AIDS, who are entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive."

In its filings challenging the patents, PUBPAT submitted prior art that Gilead had not disclosed to the Patent Office during the patent application process that resulted in the patents being granted to the Foster City, California, biopharmaceutical giant. PUBPAT also described in detail how the prior art would have prohibited the patents from being issued in the first place, had the Patent Office had been aware of it. The Patent Office has now agreed with PUBPAT and found that each of the four Gilead Sciences patents are undeserved. Although Gilead has the right to respond to the Patent Office's rejections of the patents, third party requests for re-examination, like the ones filed by PUBPAT against the four Gilead TDF patents, are successful in causing the reviewed patents to either be revoked or changed more than two-thirds of the time.

"We are extremely pleased that the Patent Office has agreed with us that Gilead's TDF patents are invalid," said Ravicher. "This means that we are now well on the way towards ending the harm being caused to the public by Gilead's use of the patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States."

The Gilead Sciences TDF patents challenged by PUBPAT that have now been rejected by the Patent Office are U.S. Patents No. 5,922,695, 5,935,946, 5,977,089 and 6,043,230. Gilead has applied for similar patents on TDF in other countries throughout the world, including India, where they have received fierce opposition by non-profit AIDS patient groups.

(Article published on Pharmalive)

Banner Pharmacaps Receives FDA Approval for Nimodipine Softgel Capsules

Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, today announced that the US Food & Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Nimodipine 30 mg soft gelatin capsules.

Banner's Nimodipine 30 mg capsules are the AB-rated generic equivalent of Bayer's Nimotop(R) 30 mg capsules, and are indicated for the treatment of subarachnoid hemorrhage, a form of cerebral bleed. Banner's product can be dispensed either in blister packaging or in bottles.

Banner has partnered with Heritage Pharmaceuticals Inc., an Edison, New Jersey based generics company, for the exclusive US sales and marketing rights for Nimodipine.

Seasonique Patent Issues

Barr Pharmaceuticals, Inc. today announced the U.S. Patent and Trademark Office (PTO) issued U.S. Patent No. 7,320,969 for the Company's SEASONIQUE(R) extended- cycle oral contraceptive. The patent will expire on January 30, 2024. The Company also announced that it has submitted the patent to the U.S. Food and Drug Administration (FDA) for issuance in the Orange Book.

"We are very pleased that the PTO has issued this important patent to protect our SEASONIQUE extended-cycle oral contraception intellectual property," said Bruce L. Downey, Barr's Chairman and CEO. "We remain committed to developing new products for our portfolio of extended-cycle oral contraceptives and to providing women with options as they consider their contraceptive alternatives."

The Company received FDA approval for SEASONIQUE (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive in May 2006. SEASONIQUE is indicated for the prevention of pregnancy and represents the next generation of extended-cycle oral contraceptives in a category the Company created with the launch of the SEASONALE extended-cycle oral contraceptive in 2003.

Fournier Laboratories Ireland Ltd was informed of anda filing for generic Tricor in the USA

Fournier Laboratories Ireland Ltd, a wholly-owned subsidiary of Solvay Pharmaceuticals, was informed by Teva Pharmaceuticals that it has filed an ANDA - Abbreviated New Drug Application - with a Paragraph IV certification, seeking the approval of a generic version of TriCor® (fenofibrate) 145mg NFE tablets in the United States.

The Paragraph IV certification procedure challenges a number of US patents relating to TriCor® which run through the next decade.

Such procedures are not unusual for branded products in the United States.

Fournier Laboratories Ireland Ltd. remains fully committed to its fenofibrate franchise and is currently evaluating its options.

Teva Announces Tentative Approval of Generic Prevacid Delayed-Release Capsules

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical's gastric-acid pump inhibitor, Prevacid(R) (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg. The brand product had annual sales of approximately $3.4 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of Delaware involving Teva's paragraph IV certification to U.S. Patent Nos. 4,628,098 and 5,045,321. A trial was held in November, at the end of which the Court indicated it anticipates it will issue a decision before the June 7, 2008 expiration of the mandatory 30-month stay of FDA approval associated with the patent litigation.

Cheaper Patents for Europe

The London Agreement modifies the EPC system for applying for European patents. It is expected that the agreement will come into force in these countries in early 2008.

Please find below the link for the whole article.

http://www.industryweek.com/ReadArticle.aspx?ArticleID=15671

FDA Issues Response on Generic KYTRIL; Teva’s Argument Takes the Day and the Company Gets 180-Day Exclusivity

As reported earlier by FDA law blog on FDA’s request for public comment to help resolve 180-day exclusivity issues concerning a generic version of the antinauseant and antiemetic drug KYTRIL (granisetron HCl) Injection. Specifically, in October 2007, FDA established a public docket in response to a letter from Teva Parenteral Medicines ("Teva"), in which the company argued that "the plain language and structure of the [FDC Act] compel the conclusion that Teva is entitled to 180-day exclusivity because Teva is the first applicant that submitted a substantially complete paragraph IV ANDA." Earlier today, FDA posted its January 17, 2008 response concluding that Teva did not forfeit 180-day exclusivity. This conclusion had been anticipated, because earlier this month Teva announced the approval of the company’s granisetron HCl ANDA with 180-day exclusivity.

At issue in this case are the "failure to market" 180-day exclusivity forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) added by the Medicare Modernization Act ("MMA") in 2003. Under these provisions, a generic applicant whose ANDA contains a paragraph IV patent certification and who is a "first applicant" eligible for 180-day exclusivity forfeits eligibility for such exclusivity if the firm fails to market the drug by the later of:

(aa) the earlier of the date that is –
(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or
(BB) 30 months after the date of submission of the application of the first applicant; or
(bb) . . . the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred:
(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.
(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.
(CC) The patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the application approved under [FDC Act § 505(b)].

In May 2004, Teva submitted the first ANDA to FDA containing a paragraph IV certification for a generic version of KYTRIL. The application also contained a paragraph III certification (date of patent expiration) and a "section viii statement" to a method-of-use patent. Roche, the NDA holder/patent owner, did not sue Teva (or any subsequent ANDA applicant) for patent infringement, and FDA tentatively approved Teva’s ANDA in August 2005. The patent subject to the paragraph III certification expired in December 2007; however, the 30-month period described in FDC Act § 505(j)(5)(D)(i)(I)(aa)(BB) above expired in November 2006.
Teva argued that despite the expiration of the 30-month period, the firm remained eligible for 180-day exclusivity, which would be triggered by Teva’s commercial marketing of the drug.
Specifically, Teva’s letter states:

[T]he plain language and structure of the [FDC Act] compel the conclusion that Teva is entitled to 180-day exclusivity because Teva is the first applicant that submitted a substantially complete paragraph IV ANDA . . . . Teva’s exclusivity has not been forfeited . . . because there is a continuing possibility of ANDA-based patent litigation that could result in a "later" forfeiture event under [FDC Act § 505(j)(5)(D)(i)(I)]. . . .

[The FDC Act] requires FDA to determine which is "the later of" (1) a determinate forfeiture trigger . . . "or" (2) a contingent forfeiture trigger . . . . But there is no conceivable way for FDA to determine which of those 2 potential triggers occurs "later" until (a) one of the contingencies that could give rise to a forfeiture trigger [under FDC Act § FDC Act § 505(j)(5)(D)(i)(I)(bb)] has occurred, or (b) none of the contingencies can occur. After all, it is impossible to know whether a contingent event has occurred before it does occur -- and twice as hard to determine that such an event will not occur until it no longer can occur.

Teva echoed this argument in the company’s comments submitted to the docket FDA established to solicit public comment on acarbose (PRECOSE) 180-day exclusivity issues.
FDA's granisetron docket response agrees with Teva’s argument. FDA states:

We find that under the plain language of the statute, 180-day exclusivity is not forfeited for failure to market when an event under subpart (aa) has occurred, but - as in this case - none of the events in subpart (bb) has occurred. The "failure to market" provision results in forfeiture when there are two dates on the basis of which FDA may identify the "later" event as described in section 505(j)(5)(D)(i)(I). The provision does not effect a forfeiture when an event under subpart (aa) has occurred, but no event under subpart (bb) has yet occurred.

This is not a situation in which it would be impossible for a later event to occur. Although at the time FDA made its exclusivity decision, there was no litigation regarding the ‘548 patent pending that could result in a forfeiture event under subitem (AA) or (BB) of subpart (bb), there was nevertheless the possibility that either an additional ANDA applicant would be sued as a result of a paragraph IV certification to the patent or one of the applicants would bring a declaratory judgment action against the NDA holder or patent owner. Either of these actions could result in a forfeiture event. In addition, the patent could be withdrawn by the NDA holder, resulting in a forfeiture event under subitem (CC). Because at least one of the events described in subpart (bb) could still have occurred and, if it did, would necessarily occur "later" than December 1, 2006, Teva did not forfeit its exclusivity.

FDA also states in a footnote that:

Inherent in the structure of the "failure to market" forfeiture provisions is the possibility that a first applicant would be able to enter into a settlement agreement with the NDA holder or patent owner in which a court does not enter a final judgment of invalidity or non-infringement (i.e., without a forfeiture event under subpart (bb) occurring), and that subsequent applicants would be unable to initiate a forfeiture with a declaratory judgment action. This inability to force a forfeiture of 180-day exclusivity could result in delays in the approval of otherwise approvable ANDAs owned by applicants that would market their generic drugs if they could but obtain approval. This potential scenario is not one for which the statute currently provides a remedy.

OVATION Receives Fast Track Designation for Sabril to Treat Cocaine and Methamphetamine Dependence

OVATION Pharmaceuticals, Inc. announced today that Sabril(R) (vigabatrin) has received Fast Track designation from the U.S. Food and Drug Administration (FDA), potentially expediting development of this novel compound that is being evaluated for the treatment of cocaine and methamphetamine dependence. Fast Track status indicates that the FDA has recognized that Sabril is intended for the treatment of a serious or life-threatening condition for which there are no available treatments and which demonstrates the potential to address unmet medical needs.

FDA Approves Intelence (etravirine) for HIV Combination Therapy

The U.S. FDA has granted accelerated approval to the anti-HIV medication INTELENCE (etravirine) tablets -- the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment- experienced adult patients with HIV resistant to a NNRTI and other antiretroviral (ARV) agents. INTELENCE, also known as TMC125, was developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.

Tekturna HCT Receives US Approval for Treatment of High Blood Pressure

Tekturna HCT® (aliskiren and hydrochlorothiazide) has been approved by the US Food and Drug Administration as a single-tablet combination of two high blood pressure medicines - Tekturna® (aliskiren), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide (HCT).

The two medicines in this single-tablet combination work together to lower blood pressure, with clinical data showing that the combination of Tekturna and HCT offers greater blood pressure reductions than either component alone.

This is the first regulatory approval of a single-tablet combination therapy involving Tekturna, known as Rasilez® outside the US, which has been shown to consistently lower blood pressure for 24 hours and beyond. HCT, sometimes called a "water pill", is one of the most commonly used high blood pressure medicines. Tekturna HCT is approved for patients not controlled by either medicine alone.

The efficacy of Tekturna for 24 hours and beyond is important because many high blood pressure medicines fail to work around the clock, especially during the early morning hours when blood pressure often surges. Tekturna has also been shown to maintain blood pressure reductions for up to four days after the last dose.

"Current guidelines call for aggressive treatment of high blood pressure and many patients are still not controlled," said Alan Gradman, MD, Division of Cardiovascular Diseases at the Western Pennsylvania Hospital in Pittsburgh, USA. "Tekturna HCT offers patients an effective new treatment option with significant blood pressure reductions and improved convenience, by combining the complementary mechanisms of action of the first direct renin inhibitor and a diuretic in one tablet."


- Tekturna HCT combines first approved direct renin inhibitor with the diuretic hydrochlorothiazide (HCT) in a single tablet.

- Approved in more than 40 countries, Tekturna used alone lowers blood pressure for 24 hours and beyond.

- Data show combination of Tekturna and HCT resulted in significant additional blood pressure reductions compared to either drug alone.

- Many patients not at goal and most require two or more medicines- single-tablet combinations simplify treatment by reducing number of pills patients take.

Abraxis Receives Approval from EU Commission to Market Abraxane for Metastatic Breast Cancer in Europe

Abraxis BioScience, Inc. (Abraxis) (NASDAQ:ABII), an integrated biotechnology company, today announced that the European Commission has granted marketing approval for ABRAXANE(R) powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol(R) in the approved indication.

"ABRAXANE provides a much-needed new treatment option for women with metastatic breast cancer in Europe," said principal clinical trial investigator William J. Gradishar, M.D., Professor of Medicine, Northwestern University, Feinberg School of Medicine, and Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern Memorial Hospital. "Given the superior patient outcomes demonstrated in two Phase III clinical trials, ABRAXANE has become the taxane therapy of choice for oncologists in the US in this setting."

ABRAXANE is now approved in 33 countries including the U.S. and Canada. In Europe, there are approximately 300,000 cases of metastatic breast cancer. The product is currently under active review in Australia, Russia, Korea and China by their respective regulatory agencies.

Labeling Change for Non-Drowsy Claritin approved by FDA

Schering-Plough today announced that the U.S. Food and Drug Administration has approved additional labeling for CLARITIN(R) (loratadine), which clearly tells consumers that the non-drowsy over-the-counter medication relieves allergy symptoms caused by both indoor (also called perennial or year-round) and outdoor (also called seasonal) allergies.

"Schering-Plough is pleased that the FDA has approved the change to the CLARITIN label to help us to communicate to consumers that CLARITIN works hard to relieve both indoor and outdoor allergies," said John E. O'Mullane, BSc, PhD, Group Vice-President, Research and Development, Schering-Plough Consumer Health Care.

Common indoor allergens include mold, dust mites, and pet dander, while common outdoor allergens include grass, tree, and ragweed pollen. Though they stem from different sources, indoor and outdoor allergies have the same pathophysiology, meaning they affect the body in the same way. Symptoms of both types of allergies include runny nose; sneezing; itchy, watery eyes; and itching of the nose or throat.

Taro Receives FDA Approval of New Drug Application for Prednisolone Acetate Oral Suspension

Taro Pharmaceutical Industries Ltd. (the “Company” or “Taro,” Pink Sheets: TAROF) reported today that its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. (“Taro USA”) has received approval from the U.S. Food and Drug Administration for its New Drug Application (NDA) for Flo-PredTM (prednisolone acetate oral suspension) equivalent to 5 mg/5 mL and 15 mg/5 mL prednisolone in Taro’s patent-protected NonSpilTM liquid drug delivery system.

The Flo-PredTM brand, for which there are no generic equivalents, will be sold by prescription as an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications.

Taro’s Flo-PredTM does not require refrigeration and does not require shaking prior to use. The patent-protected taste masking formula has a cherry flavor which may be helpful in administering the product to children.

According to industry sources, the market for prednisolone oral liquid products was approximately $55 million in 2007. The Company plans to launch the product later this year and market it through its TaroPharma Division of Taro USA.

Javelin Pharmaceuticals Expands Patent Protection for PMI-150 in Canada

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 22, 2008 - Javelin Pharmaceuticals Inc. (AMEX: JAV) today announced that it recently received notification that it had been granted a commercially important Canadian patent with broad claims, enabling greater protection of Javelin's PMI-150 (intranasal ketamine). Canadian Patent Number 2,184,007 entitled: "Nasal and Ocular Administration of ketamine to manage Pain and for Detoxification" provides protection covering Javelin's intranasal ketamine drug into 2015.

Generally, Javelin's Canadian ketamine patent covers the use of nasally administered ketamine to treat chronic pain, as well as devices used to treat pain by nasal administration of ketamine. "The device claims are significant," said David Bernstein, Javelin's General Counsel and Chief Intellectual Property Counsel, "because they offer broad protection for the idea of using ketamine intranasally to treat pain, while also providing a readily enforceable focus on a device for controlling pain rather than a method."

"This new patent, directed to Javelin's anticipated commercial formulations of PMI-150, encompasses a broad range of claims that enhance our intellectual property portfolio and commercial protections for PMI-150 in Canada," said Dr. Daniel Carr Javelin's CEO/CMO. "We believe that upon approval, PMI-150 will be the only intranasal ketamine product offering physicians and patients a non-opioid alternative for treatment of moderate to severe pain," Dr. Carr added.

Palatin Technologies Announces Patent Litigation Settlement With Competitive Technologies

CRANBURY, N.J., Jan. 22, 2008 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. announced today that it entered into an agreement to settle all outstanding litigation and disputes with Competitive Technologies, Inc. related to a license agreement between the companies. Under the terms of the settlement, Palatin retains all rights to bremelanotide, its peptide in clinical development for male erectile dysfunction and female sexual dysfunction, with no obligations for any future payments to Competitive Technologies.

Both the pending arbitration initiated by Competitive Technologies and the action in Connecticut Superior Court will be dismissed with prejudice. The existing license agreement between Palatin and Competitive Technologies has been terminated, with Competitive Technologies receiving all rights to a peptide developed at the University of Arizona and called MT-II or PT-14, which Palatin ceased developing in 2000. As part of the settlement, Palatin remitted a one-time payment to Competitive Technologies of $800,000.

"We are pleased that Palatin's full rights to bremelanotide are no longer in question," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Facing significant legal costs in the coming months in preparation for the actual arbitration hearing and removing the uncertainty inherent in litigation were the driving factors for Palatin to settle this ongoing dispute. With this favorable outcome and the matter now behind us, we look forward to continuing to develop bremelanotide and our other product candidates."

Palatin owns patents, issued in the United States and foreign countries, which claim bremelanotide and use of bremelanotide in treating sexual dysfunction. Palatin's United States patents for bremelanotide do not expire until 2020 or later.

Barr and Ortho Women's Health & Urology in Discussions to Settle Ortho Tri Cyclen Lo Patent Litigation

Barr Pharmaceuticals, Inc. today announced that the Company is in discussions with Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. concerning a definitive agreement to settle the outstanding patent litigation involving Ortho Women's Health & Urology's oral contraceptive product, ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol). The United States District Court for the District of New Jersey has postponed the trial date. The general terms and status of the anticipated settlement will not be disclosed by either party until a definitive agreement is reached.

Teva Announces Extension to Standstill Agreement with Wyeth/Altana on Generic Protonix

Jan 22, 2008 - Further to its press release dated December 24, 2007, Teva Pharmaceutical Industries Ltd. announced today that the Company and Wyeth/Altana have agreed to extend their standstill agreement regarding generic Protonix(R) (Pantoprazole Sodium), through January 31, 2008. Under the agreement, Teva agreed not to ship additional product. This extension of the standstill period will allow the parties to continue their patent litigation settlement discussions.

GSK not to develop & market XL784

Exelixis, Inc. said GlaxoSmithKline (GSK) has decided not to exercise its option to license XL784 for further development and commercialisation. Exelixis previously announced that XL784 failed to meet its primary endpoint in a phase II trial in patients with diabetic nephropathy. As a result of GSK's decision, Exelixis said it has the right to develop and commercialise XL784 either independently or in collaboration with third parties, subject to payment to GSK of a 3 per cent royalty on sales of any products incorporating the compound.

XL784 is a potent inhibitor of the ADAM-10 and MMP-2 metalloprotease enzymes, targets of significant interest because of their important role in renal fibrosis and impairment. Although the phase II trial in patients with diabetic nephropathy did not meet its primary endpoint, there were encouraging data from the trial. Exelixis believes that the exciting data being generated by other compounds to which GSK has an option under its collaboration agreement with Exelixis made it unlikely that GSK would use one of its one or two remaining options to choose XL784.

The compound was well tolerated, and the subgroup of patients who were being treated with maximal doses of ACE inhibitors or ARBs did appear to show a substantial benefit from XL784, although this difference did not reach statistical significance. Exelixis itself does not intend to invest further in the development of this drug, but will seek a partner with which to take the compound forward.

XL784 is part of Exelixis' clinical development financing arrangement with Symphony Evolution, Inc.

Exelixis is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases.

Progenics initiates phase II trials for HIV drug

Progenics Pharmaceuticals, Inc. initiated phase II clinical programme for PRO 140, an investigational drug for the treatment of human immunodeficiency virus (HIV) infection. Two phase II clinical trials in HIV-infected individuals will investigate multiple dose levels of PRO 140 via intravenous and subcutaneous routes of administration.

Intravenous PRO 140 has the potential for infrequent (e.g., monthly) dosing, whereas subcutaneous PRO 140 may enable self-administration as infrequently as every two weeks. The objective of these phase II studies is to identify an optimal dosing regimen of PRO 140 for evaluation in pivotal clinical trials as well as to further assess the investigational drug's safety and tolerability. PRO 140 is a humanised monoclonal antibody directed against CCR5, a portal that most forms of HIV use to enter immune system cells.

PRO 140 is a viral-entry inhibitor that is designed to protect healthy cells from infection. In a recent clinical study, single intravenous doses of PRO 140 significantly reduced HIV viral loads by greater than 90 per cent (1.0 log10) for two-to-three weeks.

"There is an urgent need for new therapies such as PRO 140 to address the limitations of currently available HIV drugs," said Paul J. Maddon, M.D., Ph.D., founder, chief executive officer, and chief science officer, Progenics. "Blocking the viral-entry infection pathway with a monoclonal antibody is a promising new approach to treating people with HIV/AIDS that is designed to be more specific and better tolerated than currently available medications. Following results from these phase II studies, we plan to meet with the US Food and Drug Administration (FDA) with the intention of moving into longer-term, pivotal trials in the first half of 2009."

In February 2006, PRO 140 was designated a Fast Track product by FDA for the treatment of HIV infection. The FDA Fast Track Development Programme facilitates development and expedites regulatory review of drugs intended to address an unmet medical need for serious or life-threatening conditions. With Fast Track designation for PRO 140, Progenics can take advantage of several programmes at FDA to streamline the regulatory review process and to work more closely with FDA on product development plans.

The phase II programme includes two multi-centre, double-blind, placebo-controlled studies that will be conducted in a total of 70 volunteers with early-stage HIV disease and who have not received antiretroviral therapy within the previous three months. The studies are designed to evaluate, separately, PRO 140 dosed via the intravenous or subcutaneous routes of administration. All patients will be screened prior to the study for the presence of virus that utilizes only CCR5 as the entry co-receptor. Patients will then be monitored for approximately two months to assess tolerability, antiviral activity and blood concentrations of PRO 140.

One trial is assessing intravenous PRO 140 up to 10 mg/kg. A total of 30 patients will be randomised into three groups to receive a single dose of placebo, PRO 140 5 mg/kg or PRO 140 10 mg/kg. The second trial will evaluate subcutaneous PRO 140 administered as three weekly doses or two bi-weekly (once every two weeks) doses. A total of 40 patients will be randomised into four groups to receive placebo weekly, PRO 140 162 mg weekly, PRO 140 324 mg weekly or PRO 140 324 mg biweekly. Subcutaneous PRO 140 is being developed as a potential long-acting, self-administered therapy for HIV infection.

Discovered by Progenics' scientists, PRO 140 is a humanised monoclonal antibody that binds to CCR5, a co-receptor that is the principal molecular portal used by HIV to enter and infect immune system cells. In 1996, Progenics and its collaborators discovered the role of CCR5 in HIV infection.

Progenics received development funding for PRO 140 from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on the development and commercialisation of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases.

Biocon subsidiary, Syngene to be hived off as separate company, to go public next fiscal

India's biotechnology major Biocon Ltd. plans to list its wholly-owned subsidiary Syngene Ltd. in the stock exchanges in 2008-09.

According to Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited, Syngene has attained critical mass that can be leveraged to deliver a strong growth trajectory. As one of Asia's largest and most profitable contract research firm, Syngene's initial public offering (IPO) can deliver superior shareholder value, she added.

In this regard, the company plans to approach the statutory authorities Securities Exchange Board of India (SEBI) for listing clearances after the end of this fiscal (FY 2008).Syngene is located in the Biocon Park at Bommasandra Industrial Area in the outskirts of Bangalore. It is a leading, innovation-driven, research services company conducting high value R&D in early stage drugs discovery.

In 2007, the US-based drug major Bristol-Myers Squibb entered into an agreement with Biocon in March 2007 to collaborate with Syngene in drug discovery and development at the latter's facility in Bangalore.

In September 2006, Syngene and Innate Pharmaceuticals AB, Umea, Sweden concluded a cooperation agreement to jointly develop, manufacture and market virulence blockers to counteract bacterial diarrhoeal disease. Virulence blockers are a new class of drugs that could become an alternative to antibiotics. Clinical studies of therapeutic effect will be conducted over the next three years and a candidate drug will be developed to the stage of a limited phase II study in patients with diarrhoeal disease. Once therapeutic effect is demonstrated, Syngene will carry out further clinical studies enabling the virulence blocker to be registered as a drug for the treatment of bacterial diarrhoeal disease. Innate Pharmaceuticals will have European marketing rights, while Syngene will have rights to other parts of the world market. Each company will receive royalties on the sales conducted by the other, stated Shaw.

Dr Reddy's settles patent row with Novartis on Exelon

Dr Reddy's Laboratories Ltd has entered into a settlement agreement with Novartis Pharma AG which involves a stipulation of dismissal of the lawsuits in the United States relating to the Abbreviated New Drug Applications filed by Dr Reddy's for a generic version of rivastigmine tartrate capsules sold under the trade-name Exelon.

Under the terms of the agreement, Dr Reddy's will not launch its generic rivastigmine tartrate capsules until sometime before the expiry of the Orange Book patents claiming rivastigmine. The exact date of launch and other terms of this agreement are confidential. In October 2007, the company received the final approval from US FDA on its ANDA for rivastigmine capsules.

Rivastigmine tartrate capsules is the generic version of the Novartis product Exelon indicated for the treatment of mild-to-moderate Alzheimer's disease dementia. As per the IMS June 2007 moving annual total, the annual sales of this product in the US were $199 million.

Ranbaxy settles possible patent row with GSK on Imitrex

Ranbaxy Laboratories Ltd has settled all matters relating to possible patent litigation with GlaxoSmithKline relating to sumatriptan succinate tablets, the generic version of GlaxoSmithKline's Imitrex tablets.

The terms of the settlement, provide that Ranbaxy may distribute a generic version of sumatriptan succinate tablets (in the 25 mg, 50 mg and 100 mg strengths) in the US with an expected launch date in December, 2008. Additional terms of the settlement agreement were not disclosed.

The annual market sales for sumatriptan succinate (Imitrex®) were USD 985 million (IMS- MAT: Sept 2007).

Aurobindo receives US FDA approval to sell Cefdinir in US

Aurobindo Pharma Ltd has received an approval from the USFDA to market its 300mg cefdinir capsules in the US market. This is company's 62nd ANDA approval. The drug falls under the anti-bacterial segment and is a generic equivalent of Abbott Laboratories' Omnicef. Earlier, the company also received the final approval for 125 mg/5 mL and 250 mg/5 mL oral suspension of this drug from the US FDA.

Astrazeneca sues Dr. Reddy's to block generic Nexium

AstraZeneca has filed a lawsuit against Dr. Reddy’s Laboratories Ltd., claiming the proposed generic version of blockbuster heartburn drug Nexium by the generic player infringes three AstraZeneca patents.

In a complaint filed Thursday in the U.S. District Court for the District of New Jersey, AstraZeneca alleged that the Indian generic maker’s ANDA to the USFDA for 20 mg and 40 mg delayed release esomeprazole magnesium caplets infringes its Nexium patents.

According to AstraZeneca’s complaint, Dr. Reddy’s ANDA seeks to market its esomeprazole magnesium products before the expiration of AstraZeneca’s patents, U.S. Patent Numbers. 5,714,504; 6,875,872 and 6,369,085, thus infringing the patents.

AstraZeneca claims that Dr. Reddy’s is required to submit to the FDA specific reasons why its generic product will not infringe AstraZeneca's patents. Dr. Reddy’s has failed to meet this requirement, the complaint said.

In December, AstraZeneca asked Dr. Reddy’s to supply more information and samples of its generic product so that the drug maker could determine whether the proposed product would infringe its patents.

“DRL refused to agree to timely provide AstraZeneca sufficient access to all of the requested documents, information and samples and instead offered to produce only selected portions of DRL’s ANDA Number 78-279 and certain finished product samples,” the complaint said.

AstraZeneca filed the suit in part “to employ the judicial process and the aid of discovery” to determine whether Dr. Reddy's proposed generic esomeprazole magnesium will infringe its three patents, according to the complaint.

AstraZeneca is seeking a permanent injunction barring Dr. Reddy’s from marketing an infringing product, court costs and attorneys’ fees.

In November 2005, the company asserted the three patents and others against a slew of generic makers, including Ranbaxy Pharmaceuticals Inc., Ivax Corp. and Teva Pharmaceuticals Industries Ltd. That case is still pending the New Jersey District Court.

AstraZeneca also faced challenges to Nexium from competitors in Europe. But in November, the European Patent Office reportedly ruled that a patent covering Nexium was still valid in its amended form despite challenges from four generic competitors.

In December 2006, the EPO said it had revoked the substance-of-matter patent, which was not set to expire until 2014, following an appeal from Ratiopharm.

Nexium is a slightly revised form of Prilosec, another AstraZeneca blockbuster heartburn drug. It is also one of the world’s top-selling drugs, with global sales of $2.62 billion in the first half of 2007.

US FDA approves etravirine for HIV combination therapy

The US Food and Drug Administration (FDA) has granted accelerated approval to the anti-HIV medication Intelence (etravirine) tablets -- the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment- experienced adult patients with HIV resistant to a NNRTI and other antiretroviral (ARV) agents.

Intelence, also known as TMC125, was developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the US by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.

"NNRTIs have been used in HIV combination therapy for more than a decade, but their use has been limited by cross-resistance within the class. Resistance to one NNRTI generally meant resistance to all NNRTIs," said Richard Haubrich, M.D., Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, and investigator in the Intelence Phase 3 DUET studies. "Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV."

Intelence, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.

This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of Intelence. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

The following points should be considered when initiating therapy with Intelence: Treatment history and, when available, resistance testing, should guide the use of Intelence; The use of other active antiretroviral agents with Intelence is associated with an increased likelihood of treatment response; In patients who have experienced virologic failure on a NNRTI-containing regimen, do not use Intelence in combination with only N[t]RTIs; The risks and benefits of Intelence have not been established in paediatric patients or in treatment-naïve adult patients.

FDA accelerated approval procedures allow for earlier approval of drugs that provide a meaningful therapeutic benefit over existing treatment for serious or life-threatening diseases. The Intelence approval is based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the DUET-1 and -2 studies. Longer-term data will be required before the FDA can consider traditional approval for Intelence.

"It is very inspiring to our R&D organization to see an additional compound so quickly emerge from our pipeline and reach patients who need it," said Roger Pomerantz, M.D., FACP, President, Tibotec Research and Development. "With one of the most robust virology research and development programs in the industry, we are dedicated to continuing to deliver innovative approaches in HIV management in the years to come."

"The addition of Intelence following the launch of our first antiretroviral just two years ago is a significant milestone for Tibotec Therapeutics," said Glenn Mattes, President, Tibotec Therapeutics. "In partnership with Tibotec R&D, we are committed to continuing to bring new options to people living with HIV."

Intelence is the first new NNRTI to be introduced in nearly 10 years. It is also the first NNRTI to show antiviral activity in patients with NNRTI-resistant virus. NNRTIs block reverse transcriptase, a key enzyme the HIV virus uses to replicate. NNRTI drug resistance occurs when HIV develops mutations that partially or completely stop the NNRTI from binding to the reverse transcriptase enzyme, causing the drug to lose effectiveness. As with other HIV medications, patients can develop resistance to Intelence.

According to a company press release, Intelence is expected to be available at the wholesale level in the US within one week.

Martin Delaney of the Fair Pricing Coalition said, "Tibotec Therapeutics continues to demonstrate real leadership in the pharmaceutical industry by pricing Intelence fairly and responsibly. We applaud Tibotec's responsible corporate behaviour and expect to see the drug quickly accepted on all formularies."

"With the introduction of Intelence, Tibotec Therapeutics has demonstrated exceptional leadership in working with the HIV community in an effort to address pricing and access issues. Tibotec has repeatedly recognized the necessity of responsibly pricing HIV products and should be commended for its leadership in this regard," said Lynda Dee from the AIDS Treatment Activist Coalition.

Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.

Pfizer's Lipitor safer than Merck's Simvastatin: Study

In a relief to the declining year over year sales of Pfizer's cholesterol drug Lipitor, a new study showed that the drug has significantly lower relative risk of experiencing any cardiovascular event, a heart attack, or revascularisation compared to patients who took simvastatin, Merck's hypercholesterolemia drug. This positive result is expected to boost the sales of Lipitor.

The observational study conducted in new statin users without cardiovascular disease, showed that patients taking Lipitor had a significant 12 per cent lower relative risk of experiencing a cardiovascular event. In a secondary analysis, patients taking Lipitor had a significant 15 per cent lower relative risk of experiencing a heart attack, and a significant 12 per cent lower relative risk of revascularisation compared to patients taking simvastatin. These differences were evident in patients taking doses of Lipitor or simvastatin that would have been expected to deliver similar LDL reductions (Lipitor 10 mg or 20 mg or simvastatin 20 mg or 40 mg). There was no significant difference between the groups in stroke or mini-stroke.

"An important concern for clinicians, as well as for public health in general, is whether patients treated with different statins will experience different cardiovascular outcomes," said Dr JoAnne M. Foody, associate professor of medicine at Harvard Medical School and director of the Cardiovascular Wellness Center at Brigham and Women's/Faulkner Hospitals, Boston. "This study suggests that there may be differences in cardiovascular outcomes between atorvastatin and simvastatin. Given the large number of patients receiving statin therapy, the availability of generic statins, and the clinical and economic burden of cardiovascular events, the results of this observational study could have significant public health implications."

This is one of the largest observational studies to date to examine cardiovascular outcomes in patients without cardiovascular disease treated with different statins in routine clinical practice.

The study was a retrospective analysis using anonymous patient-level health plan data from IMS Health. At the time of the analysis, the database, known as the PharMetrics Patient-Centric Database, included fully adjudicated medical and pharmacy claims for 52 million individual patients from 92 health plans across the US.

The analysis examined claims from 219,631 patients without cardiovascular disease who initiated statin therapy from January 2003 to September 2005 and who were enrolled in US health plans (168,973 patients began therapy with Lipitor 10 mg or 20 mg daily and 50,658 patients began therapy with simvastatin 20 mg or 40 mg daily). Patients were followed for a median of one and a half years.

A cardiovascular event was defined as the time to first hospitalisation due to a heart attack, chest pain or coronary artery disease, stroke, mini-stroke, vascular disease, or revascularisation.

Since patients were not randomly assigned to each group, the two treatment groups were adjusted based on certain risk factors, such as age, gender, co-morbidities and prior healthcare cost. Various statistical methods were employed to address residual imbalances.

The results of this study complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor and support findings from previously published observational studies.

According to Dr. Michael Berelowitz, senior vice president, global medical division, Pfizer, "There has been widespread encouragement by managed care companies and governments for physicians to prescribe generic statins based on what is believed to be comparable LDL-lowering doses, assuming that this will result in similar cardiovascular benefits. This analysis calls into question those assumptions and those policies and reaffirms that treatment decisions need to be made by physicians based on a patient's risk for developing cardiovascular disease."

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 144 million patient-years of experience. It is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients. There have been more than ten cardiovascular outcomes trials with more then 50,000 patients.

Boehringer Ingelheim completes enrolment of RE-LY trial

Boehringer Ingelheim has completed enrolment of the landmark RE-LY trial to evaluate the long-term efficacy and safety of their novel, oral direct thrombin inhibitor dabigatran etexilate (Pradaxa) for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).

The RE-LY (Randomised Evaluation of Long Term Anticoagulant Therapy) trial is comparing two blinded doses of oral dabigatran etexilate with the current standard therapy, warfarin (target INR 2.0-3.0) in patients with non-valvular atrial fibrillation who are at moderate to high risk of stroke. Currently, the best available treatment to prevent stroke in these patients is the vitamin K antagonist, warfarin. Although the efficacy of warfarin is well established, its use is often limited due to its inherent drawbacks. Warfarin is associated with an unpredictable dose response and requires careful individual dosing and costly anticoagulation monitoring. It has a slow onset and offset of action and its metabolism is affected by diet, common drugs and genetic polymorphisms. It is estimated that warfarin is currently prescribed for only half of all eligible patients.

RE-LY is the largest stroke prevention in AF trial conducted to date, with 18,114 patients, in 1,000 centres in 44 countries worldwide enrolled between December 2005 and December 2007. Currently, over 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.

OTC cough and cold products harmful to infants: US FDA

Despite heavy concerns over the potentially dangerous and ineffective over-the-counter (OTC) cough and cold products, parents still resort to these brands for their babies. With a cold and flu season afoot, the US Food and Drug Administration issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age.

OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of cold, the FDA said.

There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.

Big Pharmas, like Wyeth and Johnson & Johnson had taken their OTC cough and cold products off store shelves last year.

Wyeth expressed its support to FDA's decision in a separate release.

"This decision is consistent with our voluntary removal in October 2007 of over-the-counter infant cough and cold products from the global market to help reduce dosing errors and overdoses in children who are most vulnerable to misuse of these medicines," says Cavan Redmond, President, Wyeth Consumer Healthcare.

Wyeth had recalled and replaced its Robitussin products and Children's Dimetapp Cold and Chest Congestion in late November.

The announcement does not include the FDA's final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing. The FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. The agency plans to issue its recommendations on use of the products in children ages 2 to 11 years to the public as soon as the review is complete.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director, Office of Nonprescription Products, FDA. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

The statement is based on the FDA's review of data and discussion at a joint meeting of the Nonprescription Drugs and Paediatric Advisory Committees on Oct. 18 and 19, 2007.

Pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:

"These drugs will not cure or shorten the duration of the common cold. Follow the dosing directions on the label of any OTC medication before buying it and also check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients," he said. "Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs. The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold."

Pfizer Statement on Chantix (varenicline) Labeling Update in the United States

NEW YORK--(BUSINESS WIRE)--Jan 18, 2008 - Cigarette smoking is associated with significant morbidity and mortality. Smoking is the leading preventable cause of disease and premature death in the United States, with more than 438,000 U.S. deaths annually attributable to smoking. Patients who smoke cigarettes should be counseled to quit. CHANTIX(R) was approved in May of 2006 in the U.S. as an aid to smoking cessation.

Based upon post-marketing reports first reflected in a November 2007 labeling update, Pfizer today updated the CHANTIX label in the U.S. to include a warning that patients who are attempting to quit smoking with CHANTIX should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

The current update, based on Pfizer and FDA's ongoing safety review of post-marketing reports, is provided to better ensure that healthcare providers and patients will appropriately consider this information in their discussions about CHANTIX. A causal relationship between CHANTIX and these reported symptoms has not been established. In some reports, however, an association could not be excluded. More specifically, some reports may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking, but not all patients with these symptoms had quit smoking. Some patients with pre-existing psychiatric illness experienced a worsening of their conditions. By heightening awareness of these post-marketing events and facilitating this discussion, patients and doctors can play an important role in mitigating potential risk and ensuring the full benefits of CHANTIX can be realized.

"There are few things that provide greater health benefits than quitting smoking. When considering the use of CHANTIX for their patients, healthcare providers should discuss the risks of smoking, the health benefits of quitting smoking, and the product's efficacy and safety profile," said Dr. Joe Feczko, chief medical officer, Pfizer. "CHANTIX is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today's labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication."

In the controlled clinical trial program of more than 5,000 patients treated with CHANTIX, changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior occurred at a rate comparable to placebo-treated patients. There were no suicides attributed to CHANTIX in clinical trials. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the controlled clinical trial program.

CHANTIX, a selective nicotinic acetylcholine receptor partial agonist, is the first non-nicotine prescription treatment for smoking cessation in almost a decade. It has been prescribed to more than 4 million patients in the United States since approval.

Welchol (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes

PARSIPPANY, N.J., January 18, 2008 /PRNewswire/ -- Daiichi Sankyo, Inc., announced today that the United States Food and Drug Administration (FDA) has approved Welchol(TM) (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C). The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 percent of these people having type 2 diabetes.(1) Forty percent of patients with type 2 diabetes also have high LDL-cholesterol.(2) Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes.

Pivotal data presented at the American Diabetes Association's (ADA) 67th Annual Scientific Sessions in Chicago in June, 2007 demonstrated that Welchol can lower both A1C and LDL-C levels in patients with type 2 diabetes who were uncontrolled on a metformin-based regimen. Patients in the study were randomly assigned to two groups. The addition of Welchol was compared to the addition of placebo in patients on a metformin-based regimen. The addition of Welchol (n=79) to pre-existing metformin monotherapy achieved a significant mean reduction in A1C levels of 0.47 percent relative to placebo (p<0.0024). Further, the total Welchol treatment group, when treated with either metformin monotherapy or metformin-combination therapy, achieved significantly greater reductions in A1C levels compared to placebo (mean reduction of 0.54%, p<0.001). The study further demonstrated that the total Welchol treatment group achieved significantly lower LDL-C levels compared to the placebo group (mean reduction of 15.9%, p<0.001).

In addition, two other pivotal studies showed similar results in A1C reductions when Welchol was added to either sulfonylurea-based therapy or insulin-based therapy. In patients with type 2 diabetes who were inadequately controlled on sulfonylurea-based therapy the addition of Welchol was shown to have significant reductions in A1C (mean reduction of 0.54%; p<0.001) vs. placebo at week 26. In patients inadequately controlled with insulin, alone or in combination with other anti-diabetic agents, the addition of Welchol was shown to have a significant mean reduction in A1C (mean reduction of 0.50%: p<0.0001) vs. placebo.

"Welchol now offers physicians a treatment option that addresses two major cardiovascular risk factors; elevated LDL cholesterol and blood glucose in patients with type 2 diabetes," said Ronald B. Goldberg, MD, an investigator in the insulin and metformin pivotal studies and Professor of Medicine at the Division of Diabetes and Metabolism and Associate Director of the Diabetes Research Institute at the University of Miami, Miller School of Medicine in Florida. "Cardiovascular risk factors are of great concern because patients with type 2 diabetes have a significantly increased risk of developing cardiovascular disease. Once clinical cardiovascular disease develops, these patients have a poorer prognosis than normoglycemic patients."

Since 2000, Welchol, a bile acid sequestrant, has been indicated, alone or in combination with a statin, for the reduction of elevated LDL-C in patients with primary hypercholesterolemia. It is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, Welchol is not expected to have drug interactions via the cytochrome P450 pathway. Systemic medications, which include statins, fibrates and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.
Additionally, Welchol has demonstrated beneficial effects on other lipid parameters such as HDL-C and APO-B. Welchol has also been studied in combination with fenofibrate in patients with mixed dyslipidemia (Fredrickson Type IIb), and provided additional LDL-C reductions in these patients when added to a stable fenofibrate regimen. Welchol is not indicated for use in combination with fenofibrate or in the treatment of mixed dyslipidemia or lipid parameters other than LDL-C.

"We are excited by the opportunity to help more patients with chronic conditions reach their recommended health goals," said Joseph P. Pieroni, President and CEO of Daiichi Sankyo, Inc. "This approval represents an important milestone for our growing U.S. organization and underscores our continued commitment to combating cardiovascular and metabolic diseases."
People with diabetes face significantly higher risk of developing cardiovascular disease.(3) The ADA recommends that patients with type 2 diabetes target an A1C level of < 7%.(4) A1C is a common test for persistent hyperglycemia ("too much glucose in the blood"). Additionally, the National Cholesterol Education Program (NCEP) recommends that patients with type 2 diabetes keep their cholesterol levels in check and target an LDL-C goal of < 100 mg/dL.(5) Despite this recommendation, nearly 40 percent of patients with type 2 diabetes have LDL cholesterol levels greater than 130 mg/dL.(6)

It is estimated that half of all Americans have elevated blood cholesterol levels that can negatively impact their health and quality of life.(7) According to the National Healthcare Quality Report, nearly 40 percent of adults with high cholesterol also have type 2 diabetes.(8)

Roche Filed Patent Infringement Lawsuit Against Cipla

Cipla has finally launched a generic onslaught on anti-cancer patented drug Tarceva and reported to be convinced that Tarceva is not patentable and has strong case to oppose despite patent granted in India. Following the generic launch, Roche has filed an infringement case against Cipla in the Delhi High Court, which came up for its first hearing on Friday. Cipla launched generic Tarceva at Rs. 1600 compared to Roche Rs. 4800 per tablet.

Erlotinib hydrochloride, an active ingredient of Tarceva is granted Indian Patent No. 196774 (the ‘774 patent) by the Delhi Patent Office against the mail-box Application No. 537/DEL/1996 filed March 13, 1996. Under section 25(2) of the Patents Act 1970, the ‘774 patent statutorily can be opposed within one year from the date of grant of patent, which Cipla may likely consider opting for. Interestingly, Hyderabad-based generic company Natco filed a pre-grant opposition against the Tarceva mail-box Application but subsequently rejected by the Delhi Patent Office. According to Dr. Gopakumar Nair, “Erlotinib is a derivative of another known cancer drug gefitinib, a pre-1995 invention of European drug maker AstraZeneca. Since the Delhi Patent Office had denied a patent for this drug, a patent for its derivative will not be strong, and the generic company can get the patent revoked through a post-grant opposition.” Under section 25(2) the ‘774 patent can be opposed on any of the eleven grounds –

- wrongfully obtained the invention,
- prior publication,
- subject-matter claimed in already claimed in patent of earlier priority,
- publicly known or publicly used in India before the priority date,
- obvious and does not involve inventive step,
- not patentable subject-matter under the Act,
- lack sufficient and clear description of the invention, or method by which it is to be performed,
- filed not within 12 months from the priority date,
- failure to disclose information under section 8 of the Act,
- fail to disclose or wrongly disclose the source and geographical origin of biological material used in the invention, and
- anticipated having regard to the knowledge, oral or otherwise.

(post published on patent circle by Mr. Varun)

FDA Sued Over Refusal to Approve Generic DEPAKOTE After 30-Month Stay Allegedly Expires

On January 14, 2008, Nu-Pharm Inc., a Canadian drug company formerly owned by Apotex, Inc., filed a complaint in the U.S. District Court for the District of Columbia against FDA seeking declaratory and injunctive relief with respect to the company’s Abbreviated New Drug Application ("ANDA") for divalproex sodium delayed-release 500 mg tablets. The drug is marketed by Abbott Laboratories under the trade name DEPAKOTE for the treatment of mania, migraine, and epilepsy, and was first approved in 1983 under NDA #18-723.
According to the complaint, Nu-Pharm submitted ANDA #77-615 to FDA in March 2005 with paragraph IV certifications to two Orange Book-listed patents covering DEPAKOTE: U.S. Patent #4,988,731 ("the ‘731 patent") and #5,212,326 ("the ‘326 patent"). These patents are scheduled to expire on January 29, 2008; however, in December 2007, FDA granted Abbott pediatric exclusivity for the drug, thereby delaying generic approval under certain circumstances until July 29, 2008.

Earlier, Abbott sued Nu-Pharm in the U.S. District Court for the Northern District of Illinois (Eastern Division) for infringement of both patents, thereby triggering a 30-month stay of approval of Nu-Pharm’s ANDA. According to Nu-Pharm, the 30-month stay expired on November 13, 2007, without any substantive merits ruling on patent infringement. Nu-Pharm then contacted FDA requesting that the Agency grant final ANDA approval.
According to the complaint, in December 2007, FDA informed Nu-Pharm that the Agency would not grant final approval based on an order entered in a contempt proceeding in the U.S. District Court for the Northern District of Illinois (Eastern Division) in Abbott Labs v. Apotex. In that proceeding, the charged conduct was the submission of repetitive ANDAs by Apotex and Nu-Pharm to FDA for generic DEPAKOTE. In October 2007, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s judgment of contempt "because the district court erred in finding Apotex in contempt when the conduct at issue was not within the express terms of the injunction." By way of background, in previous paragraph IV patent litigation in that case concerning Apotex’s ANDA #75-112 for generic DEPAKOTE, Judge Richard Posner, sitting by designation in the U.S. District Court for the Northern District of Illinois, ruled that Apotex’s product infringed the ‘731 and ‘326 patents, enjoined the company from manufacturing, using, selling, or offering to sell generic divalproex sodium, and stated that the effective date of approval of ANDA #75-112 would be no earlier than January 29, 2008 when the patents expire - without pediatric exclusivity. The decision was affirmed in 2005. Apotex subsequently entered into an agreement with Nu-Pharm under which Apotex would pay for the costs associated with preparing and submitting a new ANDA (i.e., ANDA #77-615) for generic DEPAKOTE and Nu-Pharm would take on the "litigation risks" arising from the submission of the ANDA.

According to the Nu-Pharm complaint, FDA orally refused to grant final approval for ANDA #77-615 on January 9, 2008. Considering FDA’s decision to be final agency action, the company filed a complaint. Nu-Pharm alleges that FDA’s refusal to approve the company’s ANDA violates the FDC Act and the Administrative Procedure Act because "FDA’s decision violates the plain and unambiguous language of the [FDC Act], which provides that FDA shall immediately approve an ANDA where, as in this case, the applicable 30-month stay has expired" and there has been no finding of infringement or validity, and that FDA "has no lawful basis or authority to withhold final approval . . . based on a court order in a wholly separate contempt proceeding to which Nu-Pharm was not a party."

(Article published on FDA law blog)

Injunction against Abbott reversed for Hepatitis C Test

An appellate court on January 17, 2008 reversed part of a district court ruling in a long-standing patent dispute over hepatitis C virus testing, ruling that the lower court’s injunction barring Abbott Laboratories from selling its test was an abuse of discretion.

The U.S. Court of Appeals for the Federal Circuit upheld many of the district court’s rulings, finding in favor of plaintiff Innogenetics, the three-judge panel reversed and remanded the lower court’s judgment as a matter of law that claim 1 of the patent-in-suit was not anticipated by prior art.

The complicated case began in September 2005, when the innogenetics filed suit against Abbott in the U.S. District Court for the Western District of Wisconsin.

In its suit, Innogenetics claimed that kits sold by Abbott used to detect and classify hepatitis C virus genotypes infringed its patent, U.S. Patent No. 5,846,704. The court later held that the patent was infringed as a matter of law.

On Sept. 1, 2006, a jury found that the '704 patent was valid and seven days later awarded Innogenetics $7 million in damages.

Last January, the court overturned the jury’s finding that Abbott’s infringement had been willful. However, the judge also sustained the original $7 million award, rejected Abbott’s request for a new trial on infringement and validity and imposed the injunction.

Abbott’s appeal followed, along with an emergency plea asking the Federal Circuit to lift the injunction. For its part, Innogenetics appealed the court’s ruling overturning the jury’s willfulness finding.

The Federal Circuit immediately addressed Abbott’s emergency motion on the injunction, and stayed the injunction until it could rule on the matter. But in March, the appellate court reinstated the injunction, only to overturn it yet again 10 months later.

In addition to its appeal of the injunction, Abbott also asked the Federal Circuit to overturn the district court’s claim construction ruling; its judgment as a matter of law that Abbott literally infringed the '704 patent; its evidentiary exclusions of Abbott’s obviousness and anticipation defenses; its judgment as a matter of law that the '704 patent was not anticipated; its ruling summary judgment of no inequitable conduct and its granting of attorneys’ fees to Innogenetics.
Beyond the injunction and anticipation claims, the Federal Circuit affirmed all of the district court’s rulings, denying Abbott’s claims that the court had abused its discretion.

The appellate court also denied Innogenetic’s appeal, affirming the district court’s judgment as a matter of law that Abbott did not willfully infringe the '704 patent.

The Federal Circuit overturned the lower court’s anticipation ruling because it found that the court wrongly ruled that Abbott’s expert Dr. Patterson did not understand the claim construction outlined by the court.

“This determination by the district court, that Dr. Patterson’s testimony was tainted by an inaccurate understanding of the claim term genotyping, is clearly erroneous,” the Federal Circuit said.

“We therefore find improper the district court’s preclusion of Dr. Patterson’s testimony on the basis that he was using a different definition of ‘method of genotyping,’” the appellate court concluded. “Accordingly, we reverse the district court’s entry of JMOL and remand for a new trial on the issue of whether the Resnick patent anticipated claim 1 of the ’704 patent consistent with this opinion.”

As for the injunction, the Federal Circuit found that the damages award already given to Innogenetics by the district court included an “upfront entry fee” of $5.8 million, which “contemplates or is based upon future sales by Abbott in the long term market.”

“When a patentee requests and receives such compensation, it cannot be heard to complain that it will be irreparably harmed by future sales,” the appellate court said. “As a result, the district court’s grant of an injunction prohibiting future sales of Abbott’s genotyping assay kits was an abuse of discretion and must be vacated.”

However, the Federal Circuit remanded that part of the case so the district court could determine the terms of a compulsory license for Abbott moving forward.

Although the appellate court granted Abbott some reprieve from the district court's rulings, the overall sentiment of Thursday's ruling was that the company did not follow the rules of the court and was therefore suffering the consequences.

"This case aptly demonstrates the pitfalls of playing fast and loose with rules of discovery," the Federal Circuit said in a footnote in its ruling. "Conclusory expert reports, eleventh hour disclosures, and attempts to proffer expert testimony without compliance with Rule 26 violate both the rules and principles of discovery, and the obligations lawyers have to the court. Exclusion and forfeiture are appropriate consequences to avoid repeated occurrences of such manipulation of the litigation process."

Ranbaxy's net dips by 65 % in Q4

Ranbaxy Laboratories, India's leading pharma giant, has suffered a major setback in profits during the fourth quarter ended December 2007 despite significant rise in other income. The company's standalone net profit declined by 65.2 per cent to Rs 48.40 crore from Rs 139.07 crore in the corresponding period of last year. Its net sales also moved down by 1.2 per cent to Rs 993.32 crore from Rs 1005.85 crore. With sharp fall in bottom line, its net profit margins worked out to 4.87 per cent for the fourth quarter as against 13.83 in the last period.

The company's other income went up sharply by 323 per cent to Rs 124.79 crore from Rs 29.48 crore, which mainly includes export benefits, forex gain or loss and share of revenue from Bayer A.G. on Ciprofloxacin OD. The operating profit before interest, depreciation, taxation and exceptional items declined by 45.5 per cent to Rs 111.30 crore from Rs 204.37 crore.

For the year ended December 2007, Ranbaxy has reported standalone net profit growth of 61.2 per cent to Rs 622.99 crore from Rs 386.45 crore in the previous year. The main contributing factor to the net profit during the year is the other income of the company. However, its net sales improved only by 2.8 per cent to Rs 4,034 crore from Rs 3,925 crore. The other income went up to Rs 341 crore from Rs 79.57 crore in the previous year. Net profit margins improved to 15.44 per cent from 9.84 per cent and its operating margins reached at 24.61 per cent from 16.28 per cent. The earning per share worked out to Rs 16.71 as against Rs 10.37 in the last year.

Meanwhile, the company management has deferred its decision of demerger of New Drug Discovery Research Unit of the company into a separate entity for the time being and the same will taken up for consideration at a specifically convened Board meeting in early February, 2008.

Orchid Chemicals net jumps by 91% in Q3 due to US generic business

Orchid Chemicals and & Pharmaceuticals Ltd has posted strong performance during the third quarter ended December 2007 on account of higher income and lower interest burden. The company's standalone net profit has taken a quantum jump of 91.1 per cent to Rs 54.12 crore from Rs 28.32 crore in the corresponding period of last year. Its standalone sales increased by 39.4 per cent to Rs 332.69 crore from Rs 238.73 crore. With significant growth the bottom line, its earning per share moved up to Rs 8.20 from Rs 4.31 in the last period.

K Raghavendra Rao, managing director, said, "The third quarter has emerged as one of our strongest quarters in terms of revenue and profitability. Our niche product basket in the US market comprising Cefepime, Cefoxitin and Cefazolin injectins and Cefdinir oral products continued to accelerate our earnings positively. We continue to be the sole generic player in the Cefepime market and the dominant player in the Cefoxitin and Cefazolin segments. With further product launches lined up in the US and EU markets, we are positive on continued strong performance in the fourth quarter and beyond".

The company's US generics business contributed as much as 51 per cent to the revenues during the third quarter of this fiscal. The two premium products viz., Cefepime and Cefdinir, which were launched during the earlier quarter continued to show steady growth in terms of sales and turnover. Orchid continues to enjoy the sole generic status in Cefepime injection, a key life-saving antibiotic. Other key products launched in the US market earlier continued to show good ramp-up of market volumes with a decent share of the overall revenue mix. It also launched two new injectables like Ceftriaxone Sodium and Cefoxitin Sodium during the quarter under review.

Orchid made another Para-IV FTF (First-To-File) filing (Memantine) during the quarter ended December 2007. The cumulative ANDA filing count sands at 43. Of the total ANDAs filed, 28 are in the Cephalosporin segment, 13 in the NPNC (Non-penicillin, non-cephalosporin) segment and 2 in the Betalactam space.

The company has increased its cumulative marketing authorizations in the EU market and filing count to 14 with the submission of its first dossier in the oral NPNC segment. With this, the break-up of the EU dossier filings stands at 12 in the cephalosporin segment and 1 each in the NPNC and Betalactam segments. Its total count of ANDAs approved till date increased to 23, out of which 22 are in the Cephalosporing segment and one in the NPNC segment.

For the nine months ended December 2007, the company's net sales on the standalone basis increased by 26.2 per cent to Rs 866.02 crore from Rs 686.17 crore in the similar period of last year. It's net profit for the first nine months of 2007-08 increased by 133 per cent to Rs 168.69 crore from Rs 72.37 crore. The EPS for the period worked out to Rs 25.55 as compared to s 11.01 for the last period.

Encysive launches Thelin in Belgium & Luxembourg

Encysive Pharmaceuticals Inc. launched Thelin (sitaxentan sodium) 100 mg tablets in Belgium and Luxembourg for the treatment of pulmonary arterial hypertension (PAH).

Encysive received European Union (EU) marketing authorization for Thelin from the European Commission in August 2006. Thelin is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment commercially available for PAH patients in the EU.

Thelin is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease (CTD).

The European Commission's centralized licensing procedure permits Encysive to market Thelin in all 27 member states of the EU. Thelin has already been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained, the company said.

"With the availability of Thelin to physicians and patients in Belgium and Luxembourg, our European commercialisation strategy continues to move forward," said Thierry Plouvier, M.D., vice president, Europe Operations, Encysive (UK) Ltd. "Thelin adds an additional therapeutic option for treating patients with pulmonary arterial hypertension in the EU."

Thelin is an endothelin a receptor antagonist, a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor. Highly selective endothelin a receptor antagonism has been shown to increase blood flow and reverse vasoconstriction in human clinical pharmacology studies.

In placebo-controlled clinical trials, the most frequent adverse events that occurred in patients receiving Thelin, were headache, peripheral edema, dizziness, constipation, epistaxis, flushing, international normalized ratio (INR) increase, insomnia, nausea, upper abdominal pain, vomiting, dyspepsia, diarrhoea, fatigue, muscle cramp, and prothrombin time (PT) prolongation and nasal congestion.

It is estimated that PAH afflicts approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. Since the heart must then pump harder to overcome the resistance, patients are susceptible to heart failure.

Schering-Plough Announces Sugammadex New Drug Application Filed in Japan

KENILWORTH, N.J., January 17, 2008 /PRNewswire-FirstCall/ -- Schering-Plough Corporation announced that Nippon Organon K.K., now part of Schering-Plough, has filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking marketing approval for its novel selective relaxant binding agent (SRBA), sugammadex.

Sugammadex is specifically designed to rapidly reverse the effects of certain muscle relaxants, rocuronium bromide (marketed in the U.S. as ZEMURON(R) and in Japan as ESLAX(R)), as well as vecuronium bromide (marketed in Japan as MUSCULAX(R)). Muscle relaxants are used as part of general anesthesia during surgical procedures.

The company announced on January 2, 2008, that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the New Drug Application (NDA) filing for sugammadex. Additionally, the Marketing Authorization Application for sugammadex was accepted for review by the European Medicines Agency (EMEA) in July 2007.

Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.

FDA Approves ZymoGenetics' Recothrom Thrombin, topical (Recombinant)

SEATTLE--(BUSINESS WIRE)--Jan 17, 2008 - ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced that the United States Food and Drug Administration (FDA) has approved RECOTHROM(TM) Thrombin, topical (Recombinant) for sale. RECOTHROM, previously referred to as recombinant thrombin (rThrombin), is the first and only recombinant, plasma-free thrombin approved for use as a topical hemostat. RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. A Phase 3 pivotal clinical trial showed that RECOTHROM had comparable efficacy and a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product.

"The FDA approval of RECOTHROM recombinant thrombin is important news for patients, surgeons and hospitals," said Bruce L.A. Carter, Chief Executive Officer. "We believe that RECOTHROM has important features and benefits. We're well prepared for launch and expect to ship product in the near future."

Under a global collaboration, Bayer HealthCare Pharmaceuticals will support the launch of RECOTHROM in the US for three years. Both ZymoGenetics and Bayer field representatives, medical science liaisons and sales personnel have been thoroughly trained. The FDA approval triggers a $40 million milestone payment from Bayer HealthCare to ZymoGenetics. ZymoGenetics will compensate Bayer HealthCare for its US sales efforts by paying a tiered commission of up to 20% on US sales and up to $20 million in sales bonus payments upon achievement of certain US sales levels during a three-year co-promotion period.

In June 2007 Bayer HealthCare acquired the rights to RECOTHROM in all markets outside the US. Bayer will commercialize RECOTHROM leveraging the company's strong commercial presence in global markets. Bayer will be responsible for conducting any required clinical trials, securing regulatory approvals and commercializing the product in all countries outside the US.
"The first regulatory approval of RECOTHROM is a significant signal of the product's strong clinical data," said Hans Bishop, head of Bayer's global hematology/cardiology business unit. "RECOTHROM is an attractive addition to our specialty pharmaceutical portfolio. Our partnership with ZymoGenetics demonstrates Bayer's continued focus on working collaboratively with innovative biotechnology companies to develop and commercialize novel protein therapeutics."

Hagens Berman Sobol Shapiro Files Suit Against Merck and Schering-Plough

SEATTLE, January 17, 2008 /PRNewswire/ -- Hagens Berman Sobol Shapiro filed a proposed class-action lawsuit against Merck and Schering-Plough , manufacturers of Zetia and Vytorin, alleging Merck and Schering-Plough violated state consumer protection laws arising from the sale and marketing of Zetia and Vytorin.

Vytorin is the combination of Zetia and Zocor, a statin now available as a generic drug for about one-third of the cost.

The suit claims the companies have known since 2006 that the combination of drugs was no more effective than the generic version of Zocor in blocking the fatty arterial plaques that can cause heart attack and stroke, as it led consumers to believe.

Zetia is a brand-name prescription used to lower LDL levels by decreasing cholesterol absorption in the intestinal tract. Other cholesterol-lowering drugs known as statins work in the liver.

Zetia was developed by Schering-Plough and jointly marketed by Merck and Schering-Plough, as is Vytorin.

The companies promoted Zetia heavily, advertising that by adding it to statin treatment, patients could more effectively lower LDL cholesterol which they claim would, in turn, reduce plaque in patients' arteries.

But according to the complaint, the companies had prior information that refuted that claim.
On January 14, 2008, Merck/Schering-Plough released the results of a drug trial intended to prove the claim and show a correlation between lowered LDL levels and fatty plaques in the arteries, which can cause heart attacks and strokes.

While the study once again showed that Vytorin lowered LDL cholesterol rates better than Zocor alone, it also showed that the fatty arterial plaques actually grew somewhat faster in patients taking Zetia along with Zocor than in those taking Zocor alone.

The suit also calls into question the timing of the study's release. According to published reports, the two-year drug trial concluded April 2006 but wasn't announced until January 15, 2008. According to the complaint, Merck and Schering-Plough knew the results of the trials but delayed sharing the findings with patients and did not change its marketing approach.

Zetia and Vytorin account for combined sales of $1.1 billion during the fourth quarter of 2007. The agreement with Merck and Schering-Plough provided that the companies split profits roughly 50-50, depending on regions.

The lawsuit, filled in U.S. District Court in Seattle, seeks the return of money to purchasers of Vytorin and Zetia, which the study shows are no more effective than the generic form of Zocor. The lawsuit will not seek relief for personal injuries that anyone may allege resulted from taking Vytorin or Zetia.

Visit http://www.hbsslaw.com/zetia.htm to read a more comprehensive background document or view the complaint. You can also contact plaintiff's

APP Pharmaceuticals Receives FDA Approval for Polymyxin B Sulfate for Injection, USP

SCHAUMBURG, Ill.--(BUSINESS WIRE)--Jan 17, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Polymyxin B Sulfate for Injection, USP, 500,000 units/vial, the equivalent of Bedford Laboratories Polymyxin B Sulfate. APP expects to commence marketing the product in the first quarter of 2008. APP's polymyxin B is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2006 IMS data, sales of Polymyxin B Sulfate for Injection exceeded $13 million.

Polymyxin B Sulfate for Injection is indicated for the treatment of acute infections caused by susceptible strains of pseudomonous aeruginosa. It may be used topically or subconjunctively in the treatment of infections of the eye caused by susceptible strains of the same organism. It may also be indicated in the case of serious infections caused by specific indicated organisms.

APP Pharmaceuticals Launches Granisetron Hydrochloride Injection, USP

SCHAUMBURG, Ill.--(BUSINESS WIRE)--Jan 17, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Granisetron Hydrochloride Injection, 0.1 mg/mL, 1 mL single dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril(R) Injection. APP's Granisetron is AP-rated, preservative and latex-free, and bar-coded. According to IMS data, branded sales of this dosage form of Granisetron are expected to be approximately $3.3 million in 2007.

Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high dose cisplatin and radiation cancer therapy. Granisetron Hydrochloride Injection is also indicated for the prevention of postoperative nausea and/or vomiting.

Teva Announces Approval of Pravastatin Sodium Tablets, 80 Mg

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the USFDA has granted final approval for the Company's ANDA for Pravastatin Sodium Tablets, 80 mg.

Teva's Pravastatin Sodium Tablets, 80 mg are the AB-rated generic equivalent of Bristol-Myers Squibb's Pravachol(R) 80 mg tablets, and are indicated for treatment of certain hyperlipidemias and the primary prevention of coronary events. Teva is already marketing the 10 mg, 20 mg and 40 mg strengths of this product.

Total annual sales of the 80 mg strength, including brand and generic sales, were approximately $173 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe.

Pfizer, Scil pact to develop & market CD-RAP

Pfizer Inc and Scil Technology GmbH (Scil) have signed a licensing agreement with Scil Technology GmbH (Scil) to develop and commercialise CD-RAP, Scil's cartilage specific growth factor.

Under this agreement, Pfizer will obtain a worldwide exclusive license to develop and commercialise CD-RAP. In addition to receiving royalties on the sale of any products that may be commercialised under this agreement, Scil is eligible for upfront and milestone payments of approximately US $250 million depending on the achievement of various development and regulatory milestones.

Dr Reddy's launches pain management drug in India

Dr Reddy's Laboratories Ltd has launched Supanac (Diclofenac potassium immediate release 50 mg tablets) in India, increasing its offering in the Rs 2700 crore ( $688 million) NSAID market. (Source: IMS ORG June MAT '07).

Supanac is in-licensed from Applied Pharma Research (APR), Switzerland and is used for acute pain management. This patented product has been developed by Dynamic Buffered Technology (DBT) making it a superior formulation of Diclofenac, which reaches peak plasma concentration approximately four times faster than Diclofenac enteric coated preparations thereby ensuring faster pain relief.

Shilpa Medicare gets Korean FDA approval for gemcitabine, ambroxol HCl

Shilpa Medicare Ltd has submitted its DMF's for Ambroxol HCL and Gemcitabine HCL to South Korean FDA in 2007 and the South Korea FDA (KFDA) officials inspected the company's manufacturing facilities in last week of Nov. 2007.

The KFDA officials satisfied with the compliance of GMP Standards have approved the company's facilities for Gemcitabine HCL and Ambroxol HCL.

This is an important achievement for the company, as it is the first regulatory approval for the company and also it is the first company to get approval for Gemcitabine HCL (Oncology API) from KFDA in India. This proves that Shilpa can confidently face the other regulatory inspections for Gemcitabine HCL and other oncology API's from EDQM, France, TGA Australia, UK MHRA, and US FDA.

The company has already filed EDMF for Gemcitabine HCL in 27 European countries and also with EDQM for Certificate of Suitability. Gemcitabine HCL is going off the patent soon and worldwide market size in 2006 was US $1193 millions and growing very fast every year. Many reputed companies in Europe, India and US have started working with the company, for Gemcitabine HCL.

FDA Issues a Public Health Advisory on Edetate Disodium (Marketed as Endrate and Generic Products)

FDA has issued a public health advisory to alert patients and healthcare professionals about important safety information concerning the drug Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. As a result, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.

FDA is issuing this public health advisory to alert patients and healthcare professionals about important safety information concerning the drug Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. As a result, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.

These two drugs have very similar names and are commonly referred to only as “EDTA.” As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium work by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine.

The FDA originally approved the two drugs for very specific and very different purposes as described below.

Edetate Disodium was approved many years ago as an emergency treatment for certain patients with a condition called hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. However, there are newer drugs that have been approved since that time that treat these conditions.

Edetate Calcium Disodium was also approved many years ago and is still used to reduce dangerously high blood lead levels (severe lead poisoning). This drug is medically necessary because there are very few other drugs available to treat severe lead poisoning.

Over time, a number of uses that are not FDA approved for these products have evolved in clinical settings. Among these uses are the removal of other heavy metals from the blood and the treatment of heart disease (coronary artery disease), commonly referred to “chelation therapies.”

On March 3, 2006, the Centers for Disease Control and Prevention published an article in the Morbidity and Mortality Weekly Report documenting the deaths of people given Edetate Disodium instead of Edetate Calcium Disodium (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm). FDA was informed early in 2007 of an additional child’s death as a result of a mix-up between the two drugs. Because of the potential for these medication errors to be fatal, the CDC recommended that hospitals evaluate their need to keep Edetate Disodium stocked in their pharmacies. FDA supports this recommendation as a means of reducing the risk of confusing the two drugs.

FDA is issuing this advisory to highlight the following important safety considerations until the ongoing evaluation of the risks and benefits of Edetate Disodium is complete.

Because of the potential for these medication errors to be fatal, the FDA and CDC recommend that hospitals evaluate their need to keep Edetate Disodium stocked in their pharmacies.

If your facility determines that there is no need to have a supply of Edetate Disodium, consider removing the product from stock to reduce the risk of confusion with Edetate Calcium Disodium.
The safety or effectiveness of Edetate Disodium or Edetate Calcium Disodium for use in removing heavy metals and toxins from the body, use in treating coronary artery disease, or other uses not described in the labeling for the product have not been established.

Children and adults who are to be treated for lead poisoning should only be given the Edetate Calcium Disodium (Calcium Disodium Versenate) form of "EDTA."

Use the full product name. Do not use the abbreviation “EDTA” when prescribing or dispensing an order for either of the drugs.

Consider including the indication for use of the product on the prescribing order.
Hospitals, pharmacies and healthcare providers should always check the prescribing order and the label of the drug to confirm that the correct drug has been selected for use before dispensing and administering the drug to a patient.

FDA will determine further regulatory actions once we complete our evaluation of the safety and efficacy of Edetate Disodium.

The FDA asks healthcare professionals and patients to report serious side effects that may be associated with the use of Disodium Edetate and Edetate Calcium Disodium to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch. Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Package insert for Reyataz revised - An Update

ROCKVILLE, Md., Jan. 16, 2008--The Reyataz (atazanavir) package insert was revised to include information regarding the administration of atazanavir and/or atazanavir/ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included.

Please refer to the FDA website for details about the changes in package insert.

Marvel LifeSciences Ltd Withdraws its Marketing Authorisation Applications for Insulin Human variants

The European Medicines Agency (EMEA) has been formally notified by Marvel LifeSciences Ltd of its decision to withdraw its applications for a centralised marketing authorisation for the medicines Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel.

These medicines were expected to be used for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis and for the initial control of diabetes mellitus and diabetes mellitus in pregnancy.

The applications for marketing authorisation of the three insulins were made as applications for similar biological medicinal products, claiming that the medicines are biologically similar to a reference medicine already authorised in the European Union (Humulin, from Eli Lilly). The applications were submitted to the EMEA on 2 March 2007. At the time of the withdrawal, they were under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of the three applications was based on the decision of the CHMP not to grant an extension to the timeframe given to them to respond to a list of questions. This request was in addition to an earlier extension of three months that had been granted by the CHMP.

Keppra XR Extended-Release Tablets Filed with the FDA

UCB announced today that the New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) extended- release tablets in the adjunctive treatment of partial onset seizures in adults with epilepsy has been accepted for filing by the U.S. Food and Drug Administration (FDA).

"This filing is another important step in the development of UCB's epilepsy franchise and demonstrates our commitment to bringing new and innovative therapies to the epilepsy community," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB Group. "There is an ongoing need for new antiepileptic drug options without the limitations of twice daily dosing. Epilepsy therapies with more convenient dosing schedules may help encourage greater patient compliance, which is important to effective seizure control."

The filing for Keppra XR(TM) is supported by a Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500 mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with partial onset seizures.

The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038). The median percent reduction of partial onset seizures in the extended-release levetiracetam group was 46.1% compared to 33.4% with placebo during the 12 week treatment period. Additionally, 24.0% of patients randomized to the extended-release levetiracetam group had seizure frequency per week reduced by 75-100%, compared with 11.4% of patients in the placebo group. In the extended-release levetiracetam group 10.1% of patients had 100% reduction in partial onset seizures and 8.9% were free from any type of seizure over the treatment period, compared to 2.5% and 1.3% in the placebo group, respectively.

The study also found that extended-release levetiracetam tablets were generally well tolerated. The most common reported adverse events that occurred more frequently in the extended-release levetiracetam group were somnolence, influenza, nausea, nasopharyngitis, irritability, and dizziness

(Article published on pharmalive)

Alvesco Gains FDA Approval for the U.S. Market

ALVESCO (ciclesonide) Inhalation Aerosol Approved by FDA for the Maintenance and Prophylactic Treatment of Asthma in Patients 12 years of Age and Older.

ZURICH, Switzerland, Jan. 16, 2008 /PRNewswire/ -- Nycomed announced today that the Food and Drug Administration (FDA) approved Alvesco(ciclesonide) Inhalation Aerosol in the United States for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. ALVESCO(R) is an inhaled corticosteroid with novel release and distribution properties. Commercialisation and marketing of ALVESCO(R) will be achieved through a U.S. commercial partner.

The decision of the FDA allows the product to be sold in the largest pharmaceutical market in the world, where it is patent protected until 2017. Nycomed is in active negotiations with possible marketing partners for the commercialisation of ALVESCO(R) in the United States. The outlicensing strategy in the U.S. is consistent with Nycomed's direction to seek marketing and commercialisation partnerships for the Nycomed's assets in the U.S. market.

"The approval of ALVESCO(R) provides a new and effective treatment option to help patients control their asthma and improve their quality of life, and will be an important treatment option for physicians," said Myron Zitt, MD, chief of allergy and immunology at the Queens Long Island Medical Group in Babylon, N.Y., and clinical associate professor of medicine at the State University of New York, Stony Brook, School of Medicine.

"We are very much looking forward to serving patients in the United States with this innovative drug and build upon the experience we already have gained with ALVESCO(R). This approval certainly adds to the respiratory area, which is a key segment for Nycomed to grow", comments Dick Soderberg, Executive Vice President of International Marketing.

Teva Specialty Pharmaceuticals and UCB Announce U.S. Respiratory Collaboration Agreement

NORTH WALES, Pa. & ATLANTA--(BUSINESS WIRE)--Jan 16, 2008 - Teva Specialty Pharmaceuticals, the U.S. respiratory therapy unit of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and UCB (Euronext: UCB) today announced an agreement to co-commercialize Teva's U.S. respiratory medicines. The initial product to be jointly promoted in the U.S. is Teva's ProAir(R)HFA (albuterol sulfate) Inhalation Aerosol. ProAir(R)HFA is the number-one branded hydrofluroalkane (HFA) albuterol sulfate inhaler in the U.S. Additionally, the agreement will provide UCB future joint promotion opportunities with other products in development by Teva Specialty Pharmaceuticals. Financial terms of the agreement were not disclosed.

"Over the last months we have undertaken a rich, strategic review globally across regions, therapy areas and business units," said William S. Marth, President and CEO of Teva North America. "The respiratory therapy area has been identified as a key growth area given the incidence of asthma, allergic rhinitis, and COPD (chronic obstructive pulmonary disease). Our collaboration with UCB, a company known for excellence in the respiratory market, will help us achieve a stronger presence in this growing therapeutic area."

"UCB is focused on discovering and commercializing medicines to treat serious conditions, including asthma, and we are committed to expanding our portfolio because we believe ProAir(R)HFA has the potential to improve patient treatment options," said Fabrice Egros, President and CEO, UCB North America. "We look forward to working with Teva Specialty Pharmaceuticals for the benefit of the many Americans who suffer from this condition."

Dynogen Expands DDP225 Patent Estate

WALTHAM, Mass.--(BUSINESS WIRE)--Jan 16, 2008 - Dynogen Pharmaceuticals, Inc. today announced that the Company has acquired from Arachnova Therapeutics, Ltd. all of its worldwide patent rights and know-how related to DDP225 in an asset purchase agreement. The Arachnova patent rights, which include granted patents and pending applications related to the use of DDP225 for the treatment of functional bowel disorders, genitourinary (GU) disorders and pain, complement and enhance Dynogen's existing extensive worldwide patent estate related to DDP225. Financial terms of the agreement were not disclosed.

Dynogen is developing DDP225 as a treatment for irritable bowel syndrome with diarrhea (IBS-d), and last month announced positive clinical results of DDP225 in a Phase 2 proof of concept trial. The 1 mg dose of DDP225 achieved a 71% response rate compared to a 25% response rate for placebo in the prospectively defined clinical endpoint of adequate relief of IBS pain or discomfort. This was a statistically significant (p=0.009) benefit over placebo using an efficacy measure accepted by the FDA as the basis for approval for treatment of IBS-d. Dynogen plans to initiate a Phase 2b trial of DDP225 in 2008.

"The acquisition of Arachnova's DDP225 patent estate clarifies the patent landscape and provides Dynogen with ownership and control of all DDP225 worldwide patent rights in our therapeutic areas of interest," stated Mark Boshar, Dynogen's Vice President for Legal Affairs and Chief Patent Counsel. "Dynogen now owns 18 issued patents and more than 60 pending patent applications worldwide related to DDP225, and is well positioned to have market exclusivity for the commercialization of DDP225."
About DDP225

DDP225 is an oral noradrenaline reuptake inhibitor (NARI) and a weak 5HT3 receptor antagonist that Dynogen is developing for IBS-d. Noradrenaline and serotonin are neurotransmitters that are known to be involved in the control of the gastrointestinal system. The unique combination of noradrenaline reuptake inhibition and weak 5HT3 antagonism in one orally delivered compound represents a novel approach to treating IBS-d, enabling efficacy to be achieved at very low and well tolerated doses of DDP225. Dynogen licensed preclinical and clinical data related to DDP225 from Mitsubishi Tanabe Pharma in October 2003.

Patent Expiries of Key Therapies, Including Drugs From GlaxoSmithKline and Roche, Will Cut the Chronic Heart Failure Market in Half by 2016

WALTHAM, Mass., January 16, 2008 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the patent expiries of key therapies, most notably GlaxoSmithKline's Coreg and Roche's Dilatrend/Kredex, will cause the chronic heart failure drug market to decline by more than 50%, from $2.5 billion in 2006 to $1.2 billion in 2016.

The new Pharmacor report entitled Chronic Heart Failure finds that although the market to treat the disease has a wide array of effective and well-established treatments, many patients remain under-treated as a result of physician non-compliance with guidelines, particularly at the earlier stages of the disease. Additionally, there is no current evidence that emerging treatments for chronic heart failure offer significant improvements in patient outcome over existing therapies. Key agents in development are primarily focused on targeting cardiovascular neurohormonal pathways, such as arginine vasopressin antagonists (which include Otsuka's Tolvaptan) and renin- angiotensin aldosterone system modulators (which include Novartis's Aliskiren).

Agents that launch for chronic heart failure over the next decade are expected to be used in addition to already existing therapies in patients at the later stages of the disease who remain refractory. As such, the report forecasts that no emerging agent will replace current therapeutic options and that they will be restricted to niche populations.

"The level of mortality in chronic heart failure remains high, with the majority of patients not surviving beyond five years after diagnosis," said Graeme Green, Ph.D., analyst at Decision Resources. "Significant opportunity remains for improved treatments that can address the high level of mortality and offer longer-term survival for patients."

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.

Hi-Tech Pharmacal Receives Final Approval for Fluticasone Propionate Nasal Spray, 50mcg

AMITYVILLE, N.Y.--(BUSINESS WIRE)--Jan 16, 2008 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for fluticasone propionate nasal spray, 50mcg. Hi-Tech's fluticasone propionate nasal spray is the AB-rated generic equivalent of GlaxoSmithKline's Flonase(R), which is used in the management of the nasal symptoms of seasonal and perennial allergic and non-allergic rhinitis. Sales of branded and generic fluticasone propionate nasal spray, 50mcg was over $700 million for the 12 months ended June 2007 according to IMS sales data. Hi-Tech will begin immediate shipment of fluticasone propionate nasal spray, 50mcg.

David Seltzer, President and CEO of Hi-Tech Pharmacal said, "We are very excited about the approval of fluticasone propionate nasal spray. Given the large size of the market and the limited number of competitors, we are optimistic about the contribution that this product will make to the Company's sales and profits."

Prospects for generic players are good, as number of cardiavascular therapy related drugs are coming off patent in next 5 years.

DUBLIN, Ireland--(BUSINESS WIRE)--Jan 16, 2008 - Research and Markets (http://www.researchandmarkets.com/reports/c79614) has announced the addition of 'Cardiovascular Generic Drugs: Prospects and Opportunities to 2012' to their offering.

Cardiovascular disease is a global problem. In the developed world, its prevalence is linked to our increasingly unhealthy lifestyle, with risk factors including lack of exercise, overweight and obesity, and smoking. It is also linked to diabetes, a condition affecting an increasing number of people worldwide which greatly increases the risk of developing heart disease. The main areas targeted by cardiovascular drugs are high blood pressure and elevated blood cholesterol levels.

While the cholesterol management market remains dominated by statins and fixed-dose combination drugs containing statins, the market for drugs to treat hypertension covers a number of classes, such as beta blockers, ACE inhibitors, angiotensin-II receptor antagonists, calcium channel blockers and alpha blockers. The number of drugs to achieve blockbuster status in this sector runs into double figures and recent patent expiries have been characterised by the launch of multiple generics in this highly competitive market. This trend is likely to continue with, for example, the generic launch of the major anti-hypertensive drug ramipril onto the US market which is anticipated in October 2008.

IN FOCUS...

Statins
The most widely prescribed drugs for cholesterol management are HMG-CoA reductase inhibitors, or statins. In terms of revenue, Pfizer's Lipitor (atorvastatin) is the largest selling drug of any kind worldwide. Lipitor accounts for around 40% of the market for cholesterol management drugs by value. Without a viable replacement in the pipeline, Pfizer is keen to hold onto its Lipitor revenue for as long as possible. Ranbaxy is equally keen to launch generic atorvastatin in key markets and continues its worldwide patent litigation battle with Pfizer. While Pfizer should be able to fend off generic competition in the US at least until its basic patent expires in March 2010, Lipitor has also been facing competition from multiple entries of generic simvastatin.

Anti-Hypertensives

The global hypertension drugs market is currently valued at around US$38.5 billion. The range of drug classes available to treat high blood pressure contributes to the competitive nature of a market in which there were 13 blockbuster drugs in 2006, with combined sales of US$25.8 billion. While competition among the multinationals is significant in this lucrative segment, the marketplace for generics is equally competitive. Typically, an anti-hypertensive going off patent is highly contested with multiple generic market entrants.

The report also includes the sales forcast of the major drugs.

- Crestor
- Lescol
- Lipitor
- Pravachol/Mevalotin
- Zocor
- Zetia
- TriCor
- Vytorin
- Caduet
- Aprovel/Avapro
- Diovan/Co-Diovan
- Cozaar/Hyzaar
- Micardis
- Atacand
- Benicar/Olmetec
- Norvasc
- Adalat
- Altace/Delix/Tritace
- Accupril
- Coreg
- Seloken/Toprol-XL
- Lotrel

Companies active in the cardiovascular market are reviewed with respect to:

- Products
- Financials
- Significant developments

For more information visit http://www.researchandmarkets.com/reports/c79614

Impax Announces Lawsuit Related to Generic Version of Solodyn

HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 15, 2008 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has filed a lawsuit against Medicis Pharmaceutical Corporation in the United States District Court for the Northern District of California requesting a declaration that IMPAX does not infringe any valid claims of U.S. Patent No. 5,908,838 related to IMPAX's filing in October 2007 of an Abbreviated New Drug Application (ANDA) for minocycline hydrochloride extended-release tablets, a generic version of Solodyn(R).

IMPAX's ANDA does not contain any patent certification under Paragraph IV of the Hatch-Waxman amendments because no patents for the SOLODYN(R) product are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U. S. Food and Drug Administration. Certain antibiotic products are not subject to these Hatch-Waxman procedures and, therefore, do not have patents listed in the Orange Book and are not subject to the patent certification requirements.

Medicis Pharmaceutical Corporation markets SOLODYN(R) tablets for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. U.S. sales of SOLODYN(R) tablets were approximately $216.7 million in the 12 months ended November 30, 2007.

Nastech completes enrolment for phase 2 trial of obesity drug

Nastech Pharmaceutical Company Inc. has completed enrolment for its phase II clinical trial of PYY3-36 Nasal Spray to treat obesity. The company enrolled 551 obese patients at multiple clinical sites in the United States for a six-month, randomised, placebo-controlled dose ranging study.

The study is designed to evaluate three different doses of PYY3-36 Nasal Spray compared to placebo and sibutramine (Meridia), a commercially available oral weight loss drug, with the primary endpoint being weight loss.

"We are pleased with the rapid enrolment of 551 patients into the Phase 2 study to evaluate PYY3-36 nasal spray as a novel treatment for obesity. The fact that we exceeded our enrolment target of 510 patients is an indication of the unmet need for an effective obesity therapeutic," stated Gordon Brandt, M.D., president, Nastech. "The dramatic rise in obesity globally requires safe and effective treatment options for the hundreds of millions of people whose lives are impacted by this condition. If successful, PYY Nasal Spray would offer a patient-friendly product to promote weight loss."

Peptide YY is a naturally occurring hormone that is believed to function as a physiologic inhibitor of food intake. PYY is released into the blood stream from specialized endocrine cells (L-cells) in the gut after a meal and is believed to trigger the feeling of satiety, or fullness. Because PYY is a peptide, initial studies focused on PYY delivery by injection. Utilizing its proprietary drug delivery technology, Nastech developed the nasal spray formulation of PYY as a unique, non-invasive treatment option for obesity.

Nastech is a biopharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech is creating technologies that enable the delivery of peptide and protein therapeutics without the requirement of an injection, which is currently the most common form of administration for this class of drugs.

Magen acquires rights for dermatology applications from Lilly

Magen BioSciences, Inc., a privately held specialty pharmaceutical company, had acquired the rights to a series of novel pre-clinical compounds from Eli Lilly and Company.

Under the terms of the agreement, Magen has been granted the exclusive worldwide rights to develop and commercialize products based on these compounds for all dermatology applications. Other terms of the deal were not disclosed.

"This transaction marks a significant milestone in the growth of Magen to become a premier, science-based dermatology company," said Brian M. Gallagher, Ph.D., president and CEO. "We will leverage the prior research done by Lilly's scientists, and will dedicate our efforts to continue to advance these assets through the development process."

The licensed compounds have shown anti-inflammatory, and anti-proliferative activities in several preclinical models. These properties suggest a number of possible applications to treat common dermatological disorders.

Magen BioSciences is a research and development stage enterprise that acquires and develops novel and proprietary technologies and is headquartered in Waltham, Massachusetts.

Centocor, Catalyst tie up to develop Alterase drug candidates

Centocor Research & Development, Inc, a Johnson and Johnson unit, will support Catalyst Biosciences, Inc. in the discovery research and preclinical development of Alterase drug candidates, as part of a two year worldwide research and license agreement recently inked by the two companies.

Alterase therapeutics is next-generation, protease biologics engineered with the ability to catalytically cleave and inactivate disease-causing proteins.

Through the collaboration, Centocor will focus in the discovery research and preclinical development of Alterase drug candidates against two targets. One of the targets is in inflammatory disease. The companies did not disclose the second target but proposed an option to expand the agreement to include a third target.

Catalyst Biosciences will receive an upfront payment of $11 million, and will receive research funding for two years. The upfront payment is comprised of cash and an equity investment by Johnson & Johnson Development Corporation (JJDC). In conjunction with the equity investment and the signing of the agreement, Asish K. Xavier, Ph.D., of JJDC will join the Catalyst Biosciences Board of Directors.

Centocor will be responsible for all development, manufacturing, and commercialisation efforts associated with the Alterase products discovered through the collaboration in exchange for future milestones and royalties.

"We are very pleased to collaborate with Centocor, a leading developer of biologic therapies, to employ our Alterase drug discovery engine against high-value targets," said Nassim Usman, Ph.D., chief executive officer, Catalyst Biosciences. "We are also delighted to welcome JJDC to our premier group of investors."

Catalyst Biosciences is developing the next generation of biopharmaceuticals by harnessing the catalytic power of engineered proteases to target proteins underlying disease. Catalyst's discovery platform rapidly creates and optimises tailor-made protease drug candidates, called Alterase therapeutics, that are applicable across a broad spectrum of disease categories. To date, Catalyst has established two discovery research and product development collaborations with Wyeth Pharmaceuticals and Centocor Research & Development, Inc.

Health Canada Approves Eloxatin

LAVAL, QC, Jan. 15 /CNW/ - Health Canada has approved Eloxatin(R) (oxaliplatin for injection), in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOX4), for the adjuvant (post-surgical) treatment of patients with stage III colon cancer, after complete resection of the primary tumour. This indication is based on a demonstrated improvement in disease-free survival. Data also show a numerical improvement in overall survival after six years.

"Colorectal cancer has had a profound impact on my life and the lives of thousands of Canadians who, up until this point, have had few treatment options," says Neil Crone, Canadian actor and colorectal cancer survivor. "Canadians with colorectal cancer are fortunate to have this new treatment which provides hope for a successful recovery."

Colon cancer grows very slowly and oncologists have found that this growth is often predictable, making it simpler to treat when detected early. "The approval of Eloxatin for use after surgery provides my patients with the hope that they can better their chances of being cancer-free," says Dr. Yoo-Joung Ko, a Toronto-based oncologist. "The safety and efficacy profile of Eloxatin is clinically superior to the previous standard treatment, making this an important advancement in the treatment of the disease."

Barry D. Stein, president of the Colorectal Cancer Association of Canada, acknowledges the need for new treatment options. "My personal battle with colorectal cancer has been extremely challenging and I'm thankful that I am in a position where there is no evidence of the disease," he says. "With so many Canadians being diagnosed with colorectal cancer, the approval of Eloxatin for use in the earlier stages of the disease provides an additional opportunity for patients to prolong their lives. It brings hope to patients, their families and friends."

Dendreon Receives European Patent Covering Provenge and Company's ACI Platform Technology

SEATTLE, January 15, 2008 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that the company has been granted a broad European patent covering the company's lead product candidate Provenge(R) (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. European patent No. 0 870 022 B1 covers the composition of matter of PROVENGE as well as the company's other active cellular immunotherapy (ACI) product candidates, such as NEUVENGE(TM) (lapuleucel-T), which utilize Dendreon's Antigen Delivery Cassette(TM) technology. The patent also covers methods of activating antigen presenting cells in vitro with certain fusion proteins developed by Dendreon, including the fusion protein that is used in PROVENGE.

"The approval of this broad patent covering PROVENGE and our other active cellular immunotherapies in Europe is an important milestone for the company," stated Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "While our priority is to obtain the approval of PROVENGE in the United States, the issuance of this key patent solidifies the commercial potential of PROVENGE and our ACI platform on a more international basis. Prostate cancer is a global unmet need with, according to Cancer Research UK, approximately 670,000 men diagnosed with the disease each year, and we believe that PROVENGE could have a worldwide impact on the treatment of prostate cancer."

VIRxSYS and Lentigen Announce Litigation Settlement

GAITHERSBURG, Md., January 14, 2008 /PRNewswire/ -- VIRxSYS Corporation, a privately held company developing gene therapies for HIV and genetic diseases, and Lentigen Corporation, a privately-owned biotechnology company focused on the manufacture and development of lentiviral vectors, today announced that they have agreed to settle the pending litigation between the two companies. The parties will dismiss all claims and counterclaims asserted in the lawsuit, which has been pending in the Circuit Court for Baltimore County in Maryland. Additional terms and conditions of the settlement are confidential.

Pfizer Wins Key New York State Court Ruling on Celebrex

Pfizer Inc announced today that a New York state court ruled in favor of the company on an important motion relating to litigation over Pfizer’s Celebrex medication. New York Supreme Court Justice Shirley W. Kornreich ruled that the plaintiffs suing Pfizer in New York failed to present reliable scientific evidence necessary to prove that Celebrex can cause heart attacks and strokes at 200 mg daily – the most commonly prescribed dosage of the Pfizer pain medication. In her decision, Justice Kornreich held that “ . . . with regard to Celebrex at 200mg/d[aily], the scientific evidence, whether for a heart attack or stroke, is just not there.”

The ruling follows a similar decision in November 2007 by the U.S. District Court of Northern California in the Celebrex multi-district federal litigation. In the federal court decision, the Court held there are “no randomized controlled trials or meta-analyses of such trials or meta-analyses of observational studies that find an association between Celebrex 200 mg/day and a risk of heart attack or stroke.”

Together, the two decisions render certain expert opinions inadmissible, which we believe could result in the dismissal of many Celebrex cases. The majority of the Celebrex cases are pending in the two courts that issued the decisions.

Most of the Celebrex lawsuits were filed after the U.S. Food and Drug Administration (FDA) held advisory committee hearings in 2005 on the cardiovascular risk of non-steroidal anti-inflammatory drugs (NSAIDS), including Celebrex. The FDA concluded that based on the available data, Celebrex's benefits outweigh its risks for appropriate patients at approved doses. As a result, Celebrex has remained continuously on the market since it first became available to patients in 1999.

Although neither the New York nor federal district court ruling excludes – at this stage - all expert testimony concerning risk of heart attack or stroke in connection with plaintiffs who took more than 200 mg/daily of Celebrex in the ongoing litigation, Pfizer intends to challenge the admissibility of evidence that such higher doses might cause heart attacks or strokes in those specific cases.

“We are pleased with Justice Kornreich’s decision which, like the federal court decision, recognizes the lack of any credible evidence linking Celebrex, at its most common dosage form, with heart attacks or strokes,” said Pfizer General Counsel Allen Waxman. “We believe that these rulings will greatly limit the scope of this litigation, and we intend to continue to vigorously defend the cases against us.”

(Press release by Pfizer)

Eli Lilly again resumed gemcitabine patent claim against Mayne

Eli Lilly and Co. has again started legal action against Mayne Pharma (USA) Inc. for the infringement of two patents related to gemcitabine, filing a new complaint on Thursday after the case was administratively closed in November.

As per the complaint filed by Eli Lilly, Mayne has violated patent law by seeking FDA approval to manufacture, use and sell a “Gemcitabine Hydrochloride for Injection” pharmaceutical product. The manufacture, use, and sale of the product after FDA approval would further infringe two of Eli Lilly's patents, the company claims.

“While we don't discuss the details of any active litigation, we will vigorously assert our rights to continue to help reduce the overall costs of health care through the introduction of high quality, less costly generic products,” said Jason Hodges, spokesman for Hospira.


Patents in Issue:

US 4,808,614 and US 5,464,926.

Eli Lilly alleges Mayne's proposed products infringe a patent issued in 1989 for “Difluoro Antivirals and Intermediate Therfor,” which expires in May 2010, followed by a six-month period of market exclusivity from the FDA. The other patent encompasses the method of treating tumors in mammals with the relevant drug, and expires in November 2012, followed by six months of market exclusivity.

“Mayne's actions create a reasonable apprehension of irreparable harm and loss resulting from its threatened imminent actions,” Eli Lilly said in the complaint.

Gemzar has been a top seller for Eli Lilly, with 2005 sales of $1.3 billion. The company has shown that it is ready to fight for its rights to market Gemzar.

Eli Lilly filed a complaint against Mayne Pharma (USA) Inc. for infringing the same two patents in October 2006, but the case was administratively closed in November 2007.

In February 2006, it sued Teva Pharmaceutical Industries Ltd. and a subsidiary, Sicor Pharmaceuticals Inc., to prevent them from selling generic versions of Gemzar. Eli Lilly learned in January of that year that California-based Sicor had filed ANDAs with the FDA to market doses of gemcitabine before Eli Lilly’s patents expire.

Forest Labs. Sues generic players Over Namenda

Forest Laboratories has sued several companies including Teva Pharmaceuticals USA, Barr Laboratories Inc. and Lupin Ltd., to protect the lucrative market for the Alzheimer's drug Namenda from generic competition.

Forest and Merz Pharma GmbH & Co. KgaA filed two patent suits on Thursday in the U.S. District Court for the District of Delaware. One of the complaints names defendants including Teva, Lupin, Cobalt Laboratories Inc., Orchid Pharmaceuticals Inc., Upsher-Smith Laboratories Inc. and Wockhardt Limited. The other suit is against Barr Laboratories Inc. and Barr Pharmaceuticals Inc.

Barr has confirmed the lawsuit against him.

Namenda has a sales of $738 million for the 12 months leading up to Sept. 30, 2007, a Forest spokesman said Friday.


Patent at Issue:

US 5,061,703—entitled “Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia” and issued in 1991, expiring in 2010, but Forest has applied for an extension that would extend the patent's life through September 2013, according to Forest.

Frankfurt, Germany-based Merz is the '703 patent's sole assignee, while Forest is the patent's exclusive licensee.

The suits were triggered by the defendants filing ANDA seeking the U.S. Food and Drug Administration's approval to market generic versions of Namenda.

All of the defendants' ANDAs included allegations that the '703 patent is invalid, unenforceable and/or not infringed by the commercial manufacture, use or sale of the proposed generics, according to Forest's complaints.

Both complaints ask the court for judgments that the defendants have infringed the '703 patent and that the effective date of any approval of the ANDAs at issue can't come before the expiration of the '703 patent. Forest also wants injunctive relief barring the defendants from making, using, selling or importing any of the proposed generics before the patent expires, and an award covering the attorneys' fees and costs incurred in the suits.

Natco gets Canadian nod for ondansetron tabs

Hyderabad-based Natco Pharma Limited announced that its product 'ondansetron' tablets has approved by the Canadian regulatory agency (TPD-Health Canada).

The drug is in 4 mg and 8 mg tablets. In a statement, Natco Pharma Limited company secretary and general manager M Adinarayana Rao said the approval was accorded to Natco's marketing partner 'IP Generics' based in Canada. The drug is 'anti-emetic' and is used mainly during surgeries and chemo therapy.

Tyrosine Kinase Inhibitors: Patent Status in India

Tyrosine kinase inhibitors are significantly important class of molecular target agents for the treatment of several cancers, and have considerably drawn attention in India mostly during pre/post grant oppositions. Over the last few months, three important tyrosine kinase inhibitors made news columns in India -- namely Imatinib (Gleevec), Gefitinib (Iressa), and Erlotinibe (Tarceva) -- all opposed by Indian generic companies during pre-grant opposition period. Out of these three, Gefitinib eventually lost the bid for Indian patent and is rejected by the Delhi Patent Office on the ground of prior knowledge, and Imatinib although rejected by the Chennai Patent Office but the final decision has to be come from the Intellectual Property Appellate Board. Only Erlotinib managed to escape through the pre-grant opposition and granted patent by the Delhi Patent Office, but after news spreading about the Cipla’s claim to launch generic version the game seems to be not over for Erlotinib. Apart from these already targeted tyrosine kinase inhibitors, there are some important ones pending with Indian Patent Offices including Nilotinib and Sunitinib. Not sure whether any of other below mentioned drugs are been opposed or not, but will be pleased anyone sharing information about any changes in below status.

Status

Imatinib Mesylate/Gleevec- Novartis

Application No. 1602/MAS/98 for beta crystalline form of Imatinib rejected by the Chennai Patent Office. Novartis appeal pending for hearing in the Intellectual Property Appellate Board.
Application(s) for pre-grant opposition made against Application No. 799/CHE/2004 for alpha crystalline form of Imatinib at the Chennai Patent Office.

Sunitinib Malate/Sutent- Pfizer

Application No. IN/PCT/2002/00785/DEL for Sunitinib molecule is pending with Delhi Patent Office. Till date not heard any opposition made against the application.

Gefitinib/Iressa-AstraZeneca

Application No. 841/DEL/1996 for Gefitinib molecule rejected by the Delhi Patent Office following pre-grant opposition by Natco Pharma and JM Pharmaceuticals on the ground of known prior use.

Nilotinib Monohydrate/Tasigna-Novartis

Application No. 3003/CHENP/2004 for Nilotinib molecule is pending with Chennai Patent Office. Till date not heard any opposition made against the application.

Lapatinib Ditosylate/Tykerb-GlaxoSmithKline

Application No. 1314/CAL/1997 for Lapatinib (genus) molecule is pending with Kolkata Patent Office. Till date not heard any opposition made against the application.
Application No. IN/PCT/00/130 for Lapatinib (species) molecule is pending with Indian Patent Office. Till date not heard any opposition made against the application.
Application No. IN/PCT/2002/1457 for Ditosylate salt of Lapatinib molecule is pending with Indian Patent Office. Till date not heard any opposition made against the application.

Sorafenib Tosylate/Nexavar-Bayer

Surprisingly couldn’t trace out the Application for Sorafenib, although there are mail-box Applications for very closely chemical derivatives and analogues by Bayer itself.

Dasatinib/Sprycel-Bristol-Myer Squibb

Application No. IN/PCT/2001/01138/MUM for Dasatinib molecule is pending with the Mumbai Patent Office. Till date not heard any opposition made against the application.


This post is from (Patent circle.blogspot.com)

Merck signed an authorized-generic deal on Alendronate

Merck has signed an authorized-generic deal with an unidentified company to market a generic version of its blockbuster osteoporosis drug Fosamax (Alendronate sodium trihydrate), which could go on sale next month.Merck spokesman Ron Rogers declined to identify the generics company on Friday, saying details of the deal were proprietary at this time.Fosamax's key U.S. patent is set to expire on Feb. 6, which will clear the way for generic competition.Teva and Barr are planning to launch generic copies of Fosamax. Under federal law, Teva and Barr have been scheduled to be the only third-party marketers of generic Fosamax for about six months, because they were the first to file for Food and Drug Administration approval of generic Fosamax.But the six-month exclusivity period doesn't stop Merck from selling its own generic, either by itself or with a generic-company partner. In recent years, Merck and other branded pharmaceutical companies have begun to strike these authorized-generic deals.Critics say authorized-generic deals undercut the competitive advantage held by the generic companies that are supposed to have six-month exclusivity periods. Branded manufacturers, however, say the deals give consumers another generic option.The Federal Trade Commission is now conducting a study of the competitive impact of authorized-generic deals. It recently requested information from numerous pharmaceutical companies about the deals.Fosamax is one of Merck's best-selling drugs and was forecast to generate sales of $2.9 billion to $3.1 billion in 2007. However, sales are expected to plunge to $1.1 billion to $1.4 billion this year as a result of generic competition. Earlier this week, the FDA also advised doctors and patients about the possibility of severe and sometimes incapacitating bone, joint or muscle pain linked to Fosamax and other osteoporosis drugs.Barr said Friday that it plans to launch a generic version of Fosamax 70 milligram tablets on Feb. 6 and that it is entitled to the 180-day exclusivity period."We had anticipated sharing the exclusivity with Teva for this product," the company said. "We are not surprised that Merck is launching an authorized generic, as this has become a common antigeneric strategy for brand companies."A Teva spokeswoman couldn't immediately be reached for comment.

Glenmark's diabetes drug candidate gets intl non-proprietary name 'Melogliptin' from WHO

Glenmark Pharmaceuticals Limited, one of India's leading research-led, integrated pharmaceutical companies based in Mumbai, has received the international non-proprietary name (INN) 'Melogliptin' for its lead type II diabetes drug candidate GRC 8200, from the World Health Organization (WHO).

This name was selected during the recently held 45th consultation on non-proprietary names and was made by the international panel for pharmacopoeia and pharmaceutical preparations, said a company statement.

GRC 8200, Glenmark's lead DPPIV inhibitor, is a novel, oral DPPIV inhibitor in development for type 2 diabetes. It is currently in phase II clinical trials. Phase I studies showed that the compound was very well tolerated by the subjects at all dosage levels and there were no significant adverse events reported. More than 90 per cent inhibition of the DPP-IV enzyme was observed within one hour at all doses tested. In preclinical studies, the compound appeared to be effective and well tolerated when given at pharmacological doses.

Glenmark has 11 lead molecules at various stages of development in NCE & NBE research. Three of the leads are in phase II whereas eight other leads are into the pre-clinical and discovery stages in the broad areas of inflammation, metabolic disorders and oncology.

The company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as dermatology, internal medicine, paediatrics, gynaecology, ent, cardiology, diabetes and oncology.

Glenmark's first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. The company's second lead GRC 8200, a DPP-IV inhibitor for type II diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, undergoing phase II clinical trials in Europe, has recently been out-licensed to Eli Lilly & Company.

Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)

BOULDER, Colo., January 14, 2008 /PRNewswire-FirstCall/ -- Pharmion Corporation today announced the submission of a MAA with the European Medicines Agency (EMEA) for Vidaza(R) (azacitidine for injection) in the treatment of patients with higher-risk MDS in the European Union (EU).

Vidaza has been designated as an Orphan Medicinal Product in the EU for the treatment of MDS, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication. Vidaza has also been designated as an Orphan Medicinal Product in the EU for the treatment of acute myeloid leukemia (AML).

The application is based upon clinical data which includes the results from the Company's Phase 3 multi-center, international, randomized study of Vidaza(R) (azacitidine for injection) in the treatment of patients with higher-risk MDS. The primary objective of this Phase 3 trial was to demonstrate superiority in overall survival of Vidaza versus CCR. The study included 358 patients at sites in the U.S., Europe, and Australia. At baseline, approximately 90 percent of patients were considered to have higher- risk MDS, based on subsequent independent review of FAB subtypes or IPSS classification. Patients were assigned to treatment with Vidaza (N=179; 75 mg/m2/day SC for seven consecutive days every 28 days) or CCR. Patients assigned to CCR could receive either BSC alone (N=105), low-dose cytarabine (LDAC; N=49), or standard chemotherapy (Std Chemo; N=25). The median number of cycles for Vidaza was nine; the median number of cycles for the CCR arm was as follows: BSC seven cycles, LDAC 4.5 cycles and Std Chemo one cycle.

With a median follow-up of 21.1 months, Vidaza demonstrated a statistically significant overall survival advantage over CCR (24.4 months vs. 15 months; stratified log rank p=0.0001).The hazard ratio describing this treatment effect was 0.58 (95 percent confidence interval of 0.43 to 0.77). At two years, Vidaza demonstrated a two-fold advantage in overall survival over CCR (51 percent vs. 26 percent; log rank p<0.0001). Among patients with poor cytogenetic profiles (as defined by IPSS, 28 percent of enrolled patients), median survival was 17.2 months in the Vidaza arm, compared to six months in the CCR arm (log rank p=0.01). Forty-five percent of transfusion- dependent patients on Vidaza achieved transfusion independence compared to 11 percent of transfusion-dependent patients on CCR, and for patients on Vidaza, the median time to transformation to AML during the treatment period was 26 months, compared to 12 months for patients on CCR therapy.

Treatment with Vidaza was well tolerated, demonstrating a safety profile consistent with previous experience.

Vidaza is the first of a new class of anti-cancer compounds known as demethylating agents, a subset of a category of drugs referred to as epigenetic therapies. Epigenetics refers to changes in the regulation of gene expression. DNA methylation and histone deacetylation are two of the more widely studied epigenetic mechanisms.

FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., January 14, 2008 /PRNewswire-FirstCall/ -- Genta Incorporated announced today that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense(R) (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia. The Company had previously provided guidance that a final decision would be available in the fourth quarter of 2007. Genta now envisions receiving this notification later in the current quarter.

FDA Approves Tysabri for the Treatment of Moderate-to-Severe Crohn's Disease

DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 14, 2008 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for TYSABRI(R) (natalizumab). TYSABRI is now approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. TYSABRI will be available for the treatment of CD upon the completion of key implementation activities related to the approved risk management plan. The companies anticipate TYSABRI will be available to Crohn's patients by the end of February 2008.

"The FDA's approval of TYSABRI is an important step forward in the treatment of Crohn's disease," said Dr. Stephen Hanauer, Professor of Medicine & Clinical Pharmacology & Chief of the Section of Gastroenterology at the University of Chicago Pritzker School of Medicine. "A significant number of patients either fail or cannot tolerate current therapies. The unique mechanism of action of TYSABRI affords us a new class of therapy in our fight against this debilitating disease."

The FDA granted approval based on its review of TYSABRI CD clinical trial data and overall safety data. The approval is accompanied by robust labeling with safety warnings; and a CD-specific risk management plan (including the mandatory TOUCH(TM) Prescribing Program) designed to inform prescribers, patients and infusion centers about the use of TYSABRI and to minimize potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.

"We are delighted that TYSABRI will be available for Crohn's patients and their physicians, who continue to need new therapeutic options with novel mechanisms of action," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan. "We are committed to providing therapeutic choice to those patients who can benefit from TYSABRI, and will continue to work with the FDA and the medical community to implement the TOUCH(TM) Prescribing Program for Crohn's patients."

"We are pleased with the FDA's decision to make TYSABRI available to Crohn's patients suffering from this chronic, debilitating disease," said Evan Beckman, MD, Senior Vice President, Immunology Research and Development, Biogen Idec. "Despite the therapeutic advances of the TNF-alpha inhibitors in CD, there remains a significant unmet need for Crohn's patients who have inadequate responses to, or are unable to tolerate, current CD therapies."

King Pharmaceuticals Reports FDA Approval of Revised Labeling Regarding Purity of THROMBIN-JMI

BRISTOL, Tenn.--(BUSINESS WIRE)--Jan 14, 2008 - King Pharmaceuticals, Inc. (NYSE:KG) today reported that the U.S. Food and Drug Administration (FDA) has approved revised labeling for THROMBIN-JMI(R) (thrombin, topical, bovine, USP) as a result of continuous enhancements the Company has made with respect to its manufacturing processes for the product. The revised labeling recognizes the capability of King's enhanced processes to reduce Factor V light chain content to undetectable levels using currently available methodologies. Supporting data is being published as a paper in an upcoming issue of Clinical and Applied Thrombosis/Hemostasis. High purity THROMBIN-JMI(R) with this labeling will be available beginning in March 2008.

"This new labeling for THROMBIN-JMI(R) reflects King's commitment to continually enhance the processes utilized in the manufacture of this product for the benefit of surgeons, healthcare professionals and patients," said Craig A. Paterson, MD, MBA, Senior Director, Medical Development, King Pharmaceuticals, Inc.

The new labeling states:
"THROMBIN-JMI(R) has been chromatographically purified and further processed by ultrafiltration. Analytical studies demonstrate the current manufacturing process' capability to remove significant amounts of extraneous proteins, and result in a reduction of Factor Va light chain content levels below the limit of detection of semi-quantitative Western Blot assay (less than 92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown."

Some studies have proposed that if bovine Factor V is present in bovine thrombin, it may elicit the formation of antibodies that could cross-react with human Factor V and possibly lead to clinically significant bleeding (coagulopathy). Specific studies evaluating a causative relationship between bovine Factor V levels, human antibody formation to bovine proteins including thrombin and Factor V, and serious coagulopathies have never been performed. However, well-controlled clinical trials with THROMBIN-JMI(R) have not demonstrated an increase in coagulopathy. Therefore, the clinical significance of antibodies to bovine proteins remains unknown.

THROMBIN-JMI(R) is an active topical hemostat that achieves fast, active control of surgical bleeding (hemostasis). It is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small veins is accessible, or in conjunction with an absorbable gelatin sponge, USP. Since its approval more than 12 years ago, THROMBIN-JMI(R) has been used in an estimated 12 million patient procedures.

THROMBIN-JMI(R), available in a broad range of delivery options, helps surgeons and healthcare professionals achieve hemostasis in a variety of procedures and bleeding sites. In addition to THROMBIN-JMI(R) syringe spray kits, these include: THROMBI-Gel(R) (thrombin/gelatin foam hemostat), which provides a convenient topical hemostat option for operating room surgeons; THROMBI-Pad(TM) (3x3 hemostatic pad), the only composite of THROMBIN-JMI(R) and gauze pad, offering healthcare professionals in the emergency department a convenient option to achieve active hemostasis at bleeding sites where they would typically use trauma dressing; and the THROMBIN-JMI(R) Epistaxis Kit, an intranasal spray delivery device to aid in stopping epistaxes (nosebleeds).

Encysive Pharmaceuticals Launches Thelin (sitaxentan sodium) in Belgium and Luxembourg

HOUSTON, Jan. 14, 2008 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced the commercial availability of Thelin(r)(1) (sitaxentan sodium(2)) 100 mg tablets in Belgium and Luxembourg for the treatment of pulmonary arterial hypertension (PAH). Encysive received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment commercially available for PAH patients in the EU.

THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
The European Commission's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the EU. THELIN has already been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.
"With the availability of THELIN to physicians and patients in Belgium and Luxembourg, our European commercialization strategy continues to move forward," said Thierry Plouvier, M.D., Vice President, Europe Operations, for Encysive (UK) Ltd. "THELIN adds an additional therapeutic option for treating patients with pulmonary arterial hypertension in the EU."

Patents Granted or given notice of allowance

Kibow Biotech, Inc. is pleased to announce that it has been granted an International Patent Cooperation Treaty (PCT) patent from Australia, China and India. The approved patent, "Prebiotic and Probiotic Compositions and their Method of use for Gut-based Therapy," protects the composition and method behind the Company's oral probiotic product formulation (Kibow Biotics(R)) which may significantly reduce concentrations of several nitrogenous waste metabolites that accumulate in renal deficiency. The serial numbers for this patent are: 20022342641 (Australia), ZL 02810078.6 (China) and 1029/MUMNP/2003, 205478 (India). Kibow Biotech has an identical PCT patent pending in Canada, the European Union, Japan, and South Korea.

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has received allowance of its patent application in India covering its lead dermatology agent, PH-10, along with a number of related agents. The pending patent covers topical products for treatment of skin diseases such as psoriasis and eczema. Additionally, a range of active compounds are protected, each related to the active ingredient in PH-10.

CEVEC Pharmaceuticals GmbH, the specialist supplier for human expression technologies, today announced that an opposition to a patent owned by Crucell N.V., Leiden, Netherlands, before the European Patent Office was again successful. This is the second time within a year that the Opposition Division of the European Patent Office (EPO) has restricted a patent on Crucell’s PER.C6 cell line.

Supreme Court Declines to Consider Whether Those Near Death Have Right of Access to Experimental Drugs

WASHINGTON, Jan. 14, 2008--The U.S. Supreme Court issued an order today declining to take up the issue of whether terminally ill patients have a “fundamental right” – protected by the U.S. Constitution – to access to experimental drugs that have not yet been fully approved by the Food and Drug Administration (FDA). The denial was a setback for the Washington Legal Foundation (WLF), which filed the review petition on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients-rights group.

The Court’s decision marks the latest chapter in WLF’s five-year effort to establish rights for terminally ill patients. Because of FDA’s refusal to recognize such rights, WLF filed suit in 2003 on behalf of itself and the Abigail Alliance. In May 2006, a panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled in WLF’s favor on the issue. But in August 2007, a divided appeals court sitting en banc reversed that decision. WLF asked the Supreme Court to hear the case and reinstate the panel decision. Commenting on the Court’s decision not to review the case, WLF’s Chief Counsel said:

We will continue our efforts to persuade FDA that terminally ill patients deserve better access to drugs that FDA has deemed suitable for large-scale clinical trials. Under FDA regulations, the vast majority of patients with life-threatening illnesses do not have access to promising new medications during the years of clinical testing and review required by FDA. The drugs remain unavailable even though there is evidence that they are safe and effective and even though patients have no alternative to the drugs other than to wait for their own deaths.

WLF had urged the Court to hold that once FDA has determined, after Phase I trials, that a potentially life-saving investigational new drug is sufficiently safe for expanded human trials, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available to the patient. WLF argued that the Fifth Amendment’s Due Process Clause encompasses a right, recognized throughout American history, of all individuals facing terminal illnesses to make fundamental decisions regarding whether to seek or not to seek medical treatment. WLF argued that if FDA wishes to prevent such patients from gaining access to investigational drugs that have completed Phase I trials, it bears the burden of demonstrating that its restrictions are “narrowly tailored” to serve a compelling governmental interest.

Forest Laboratories, Inc. and Merz Pharma GmbH & Co. KgaA File Lawsuits Against Several Companies for Patent Infringement

NEW YORK, January 10, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KgaA, and Merz Pharmaceuticals GmbH announced that they have filed lawsuits in the U.S. District Court for the District of Delaware against several companies for infringement of U.S. Patent No. 5,061,703 (the '703 patent), which relates to Forest's Namenda(R) product. The defendants named in the lawsuits include Barr Laboratories, Inc., Cobalt Laboratories, Inc., Lupin Ltd., Orchid Chemicals & Pharmaceuticals Ltd., Teva Pharmaceuticals USA, Inc., Upsher-Smith Laboratories Inc., Wockhardt Ltd., and related companies and subsidiaries thereof. The '703 patent expires in April 2010. Forest has applied for patent term extension which, if granted, would extend the '703 patent until September 2013.

As previously reported, Forest had received notification from several companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications to obtain approval to market generic versions of Namenda.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in each of Forest Laboratories' Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

Barr Confirms Patent Challenge of Namenda Tablets, 5mg & 10mg

MONTVALE, N.J., January 11, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Forest Laboratories, Inc. in connection with its Namenda(R) (memantine hydrochloride) tablets, 5mg and 10mg.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Namenda product with the U.S. Food & Drug Administration (FDA) on October 16, 2007, the first date the FDA could accept an ANDA with a paragraph IV certification for this product. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.

On January 10, 2008, Forest Laboratories Holdings, Ltd., Forest Laboratories, Inc., Merz Pharma GmbH & Co. KgaA, and Merz Pharmaceuticals GmbH filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Namenda (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The product had sales of approximately $824 million in the U.S., based on IMS sales data ending October 2007.

Breckenridge Pharmaceutical Settles 'Paragraph IV' Litigation and Receives FDA Approval for its Oxcarbazepine ANDA

BOCA RATON, Fla., January 11, 2008 /PRNewswire-FirstCall/ -- Breckenridge Pharmaceutical, Inc. announced today that it settled "Paragraph IV" litigation with Novartis concerning Trileptal(R) and that the U.S. Food and Drug Administration approved Breckenridge's Abbreviated New Drug Application for oxcarbazepine 150mg, 300mg and 600 mg tablets in the United States ("Oxcarbazepine Tablets").

Breckenridge enjoys a shared 180-day exclusivity period and will immediately launch Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. Oxcarbazepine Tablets are AB rated to Trileptal(R), a $600 million brand name drug marketed by Novartis Pharmaceuticals Corporation, and are used in treating seizures.

Breckenridge is actively seeking development and marketing alliances with domestic and foreign companies for generic and branded pharmaceuticals.

Breckenridge products are contract manufactured through partnerships with pharmaceutical manufacturers in state-of-the-art facilities throughout the U.S. Breckenridge maintains a stringent Quality Assurance program to ensure a consistent supply of quality pharmaceutical products.

Pfizer Receives Initial Communication from U.S. Patent and Trademark Office Regarding Lipitor Basic Patent

NEW YORK--(BUSINESS WIRE)--Jan 14, 2008 - Pfizer Inc announced today that the U.S. Patent & Trademark Office has issued its first communication in the reexamination of the '893 basic patent for Lipitor, initially rejecting the patent's claims. This initial action, which is how the Office raises its issues with the patentee, will now be followed by the company's response, in which Pfizer will address those issues raised by the examiner. As the company previously indicated, an initial rejection is not unusual in reexamination proceedings.

"We will respond as appropriate to the issues raised by the examiner, and believe we have compelling arguments in our favor," said Pfizer General Counsel Allen Waxman. "We continue to believe that the basic patent was properly granted and will be upheld on reexamination. This initial action, which was not unexpected, does not change that."

The patent remains valid and enforceable throughout the re-examination proceeding, which could take as long as a few years.

Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip

DETROIT, January 14, 2008 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl).

Glipizide/Metformin HCl is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. It is also indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. Our generic Glipizide/Metformin HCl is the bioequivalent to Metaglip(R), a registered trademark of Bristol-Myers Squibb Company. According to IMS Data, for the twelve months ended September 2007, Glipizide/Metformin HCl generic and brand products (Metaglip(R)) combined had annual sales of approximately $25 million.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain this approval from the FDA. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value."

Teva Announces Tentative Approval of Generic Aricept Tablets

JERUSALEM--(BUSINESS WIRE)--Jan 14, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Eisai's Alzheimer's treatment Aricept(R) (Donepezil Hydrochloride) Tablets, 5 mg and 10 mg. The brand product had annual sales of approximately $1.6 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of New Jersey involving Teva's paragraph IV certification to U.S. Patent No. 4,895,841. Although a trial date has not been set, the Court has set a briefing schedule for a preliminary injunction motion under which Eisai must file its request no later than February 15, 2008. Final approval of this ANDA is anticipated on or about April 26, 2008, upon expiry of the mandatory stay of approval associated with the patent litigation.

TAP pharma files NDA for proton pump inhibitor TAK-390MR

TAP Pharmaceutical Products Inc, a joint venture between Takeda Pharmaceutical Company Limited and Abbott Laboratories, had submitted a New Drug Application (NDA) to the US Food and Drug Administration for TAK-390MR, a proton pump inhibitor.

TAK-390MR employs a novel modified release technology on dexlansoprazole discovered by Takeda. The NDA submission this time is for the use of TAK-390MR in the treatment and maintenance of patients with erosive esophagitis and non-erosive reflux disease, and is based on global studies conducted in more than 20 countries. These studies evaluated more than 6,000 subjects with erosive and non-erosive GERD.

"We are very much pleased with the NDA submission of TAK-390MR," said Yasuchika Hasegawa, president, Takeda. "We expect TAK-390MR will contribute as a novel treatment option for the patients with such acid related disorders and healthcare provides who treat them, and also will enhance TAP's well established gastroenterology franchise in the US marketplace once approved."

Addex, Merck tie up to develop Schizophrenia drug

With an aim to develop ADX63365, an orally available drug candidate for the potential treatment of schizophrenia and other undisclosed indications, allosteric modulation company Addex Pharmaceuticals has signed an exclusive worldwide license agreement with Merck & Co., Inc. The deal also includes mGluR5 PAM backup compounds discovered by Addex, revealed the company source.

ADX63365, currently in preclinical development, is a positive allosteric modulator (PAM) that targets the metabotropic glutamate receptor 5 (mGluR5), which is believed to be important as a target for the treatment of schizophrenia and other conditions. Allosteric modulators are an emerging new class of therapeutic agents.

Under the terms of the agreement, Addex will receive $22 million upfront fee and up to $455 million in research, development, regulatory and sales milestones for the first product developed for two indications. Also the company is eligible to receive up to $225 million in additional development, regulatory and sales milestones for a second product developed in two indications.

Addex said it would also receive royalties on sales of any products resulting from this collaboration. In addition, the company has an option to co-promote in certain European Union countries and will participate in the joint oversight committee for further development that will be led by Merck.

"We are thrilled to establish a second deal with Merck to develop this groundbreaking new approach for patients suffering from schizophrenia and other important diseases," said, Vincent Mutel, CEO, Addex. "This deal confirms that Addex can successfully leverage its technology to produce drug candidates that can have broad benefit for human health."

"Merck scientists were the first to identify the potential for targeting mGluR5 to treat schizophrenia," said, Darryle D. Schoepp, senior vice president and franchise head, neuroscience, Merck Research Laboratories. "Through this second collaboration with Addex, we have now gained access to a promising drug candidate targeting this receptor that potentially allows us to address an area of high medical importance where current therapies are clearly inadequate.

"Earlier, on December 3, 2007, Addex announced a separate collaboration with an affiliate of Merck, Merck Sharp & Dohme Research Ltd, to discover and develop PAMs targeting mGluR4 for the treatment of parkinson's disease and other undisclosed indications.

"We now expect 2008 full year cash burn to be in the range of CHF 25-30 million," said, Tim Dyer, CFO of Addex. mGluR5 in SchizophreniaPreclinical research shows that activation of mGluR5 using positive allosteric modulators can act as an antipsychotic and reverse cognitive dysfunction of schizophrenia. As a result, a product like ADX63365 could become first-line anti-psychotic therapy that also improves cognitive dysfunction, thereby offering substantial advantages over other therapies on the market or in development. In schizophrenia cognitive impairment is regarded as a core deficit and was recently recognized by FDA as a separate indication within schizophrenia for which a drug could win approval.

Daiichi, Lilly submit NDA for blood-thinning drug Prasugrel

Daiichi Sankyo Company, Limited and Eli Lilly and Company have submitted a New Drug Application (NDA) for blood-thinning drug Prasugrel to the US Food and Drug Administration (FDA).

Prasugrel is an oral antiplatelet agent, initially in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting.

If approved for marketing in the United States, the trade name for prasugrel will be Effient, company officials added. "We are elated," said J Anthony Ware, M D, vice president, Lilly and cardiovascular/acute care platform leader for prasugrel. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008. The benefit/risk profile of this compound, in comparison with the current standard of care, has the potential to improve outcomes for ACS patients undergoing PCI".

The NDA is based upon data from several trials, including the landmark TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix/Iscover) in reducing ischemic events such as non-fatal heart attack, non-fatal stroke and cardiovascular death in 13,608 patients. In the study, treatment with prasugrel resulted in a: - 19 per cent relative risk reduction compared with clopidogrel in all ACS patients in the primary composite endpoint of non-fatal heart attack, non-fatal stroke or cardiovascular death, 52 per cent reduction compared with clopidogrel in stent thrombosis. 30 per cent relative risk reduction compared to clopidogrel in a subset of patients with diabetes on the composite endpoint of non-fatal heart attack, non-fatal stroke, or cardiovascular death.

Risk reductions in the primary composite endpoint with prasugrel compared to clopidogrel were seen as early as three days and continued to diverge for 15 months (the duration of the trial.) Though the incidence of non-coronary artery bypass grafting(non-CABG) bleeding in Triton was low in both the prasugrel and clopidogrel treatment groups, prasugrel-treated patients experienced significantly higher non-CABG major bleeding and higher rates of life- threatening bleeding. "Given the overall results from Triton, this submission is particularly meaningful considering that cardiovascular disease is the leading cause of death in the United States and worldwide, killing 16.7 million people each year," said John Alexander, MD, M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

Noven Receives FDA Warning Letter Related to Mid-2007 Facility Inspection

MIAMI--(BUSINESS WIRE)--Jan 10, 2008 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced that yesterday it received a warning letter from the U.S. Food and Drug Administration (FDA) related to a prior on-site inspection of Noven's Miami manufacturing facility.

The FDA inspection concluded in early July 2007 and, as disclosed at that time by Noven, resulted in FDA observations on Form 483. The majority of the observations on Form 483 related to difficulties experienced by some patients in removing the release liner of the Daytrana(TM) transdermal system. Noven submitted a response to the FDA's observations in July 2007.

In the warning letter, the FDA cites Current Good Manufacturing Practice deficiencies related to (i) peel force specifications for removal of Daytrana's release liner, and (ii) data supporting the peel force characteristics of Daytrana's enhanced release liner throughout the product's shelf life. The warning letter does not restrict production or shipment of Daytrana(TM) product; it does request additional information and analysis related to the cited deficiencies, instructs Noven to take prompt action to address the FDA's concerns, and states that failure to do so may result in further regulatory action.

"Compliance with FDA regulations is taken very seriously at Noven, and this matter is receiving the highest priority within the company," said Jeffrey F. Eisenberg, Noven's Interim Chief Executive Officer. "We are working very closely with Shire, the global licensee of Daytrana(TM), to promptly respond to the FDA's letter, and we are committed to working collaboratively with the FDA to fully resolve the issues."

The warning letter will be posted on the FDA's website at www.fda.gov and, once posted, will be available for viewing.

Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting

BASEL, Switzerland, Jan. 10, 2008 - Basilea Pharmaceutica Ltd. (SWX: BSLN) announced that in accordance with the further amendment of Section 505 of the Federal Food, Drug, and Cosmetic Act, ceftobiprole, as a new chemical entity (NCE), has been assigned a review by the FDA Anti-Infective Drug Advisory Committee on February 28th, 2008.

The ceftobiprole New Drug Application (NDA) currently under review by the U.S. Food and Drug Administration (FDA) seeks an indication for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections. Ceftobiprole is the first anti-MRSA broad-spectrum cephalosporin to complete phase III clinical trials, and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C., who submitted the NDA for ceftobiprole.

Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months

TARRYTOWN, N.Y. & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Jan 10, 2008 - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the action date for its review of the New Drug Application (NDA) for subcutaneous methylnaltrexone. The FDA's revised action date for methylnaltrexone, currently being reviewed for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care, is now April 30, 2008.

The FDA, in its review of this NDA, requested the results from a recently completed QT study of intravenous methylnaltrexone, which is being developed for the management of post-operative ileus (POI). This study, which was submitted to the FDA, reported that there was no evidence of an effect of methylnaltrexone on QT prolongation. The FDA recently notified Progenics that it needs the extended time to review fully this study.

"We, along with our collaborator, Wyeth, are confident in our subcutaneous methylnaltrexone submission," says Paul J. Maddon, M.D., Ph.D, Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We are enthusiastic about the entire methylnaltrexone program and plan to submit an NDA for the intravenous formulation of methylnaltrexone for the management of post-operative ileus later this year."

OMRIX Biopharmaceuticals Receives FDA Approval for General Hemostasis in Surgery Indication for Evicel Liquid Fibrin Sealant (Human)

NEW YORK--(BUSINESS WIRE)--Jan 10, 2008 - OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI) announced today that the U.S. Food and Drug Administration has granted an expanded indication for general hemostasis in surgery for EVICEL(TM) Liquid Fibrin Sealant (Human). EVICEL is the first liquid fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.

"Although Fibrin Sealants have been commercially available in the U.S. since 1999, their potential remains largely unexplored. FDA approval of the clinical supplement and general hemostasis in surgery indication for EVICEL are important developments as they significantly expand the market potential for this product and bring us closer to our stated objective of creating a one-stop-shop for biological hemostats," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Ethicon, Inc., our marketing partner, will now actively promote EVICEL for a wide range of surgeries."

The approval of the general hemostasis in surgery indication is based on the submission of clinical data related to three pivotal studies conducted in three different surgical procedures with challenging bleeding. The pivotal study included in the last submitted clinical supplement is entitled: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding during Retroperitoneal or Intra-abdominal Surgery.

In this clinical study, EVICEL was shown to be superior to the control product (Surgicel(R), oxidized regenerated cellulose) in achieving hemostasis in less than 10 minutes. Superiority was also established at the secondary efficacy endpoints of 7 and 4 minutes.

Juvéderm ULTRA: Next-Generation Dermal Filler Containing Lidocaine Now Available in Europe

PARIS, Jan. 10, 2008 – Today at the International Master Course on Aging Skin (IMCAS), Allergan, the makers of BOTOX®/VISTABEL®/VISTABEX® (botulinum toxin type A, announced the launch of Juvéderm® ULTRA for the treatment of facial wrinkles and folds. Juvéderm® ULTRA is a hyaluronic acid dermal filler containing lidocaine, an anaesthetic that allows for a gentle injection experience. According to preliminary results from a study of 60 women released at IMCAS, 81% of people who received Juvederm® ULTRA felt only slight or no discomfort at all.