Novartis and FDA Complete Two-year Cooperative Research & Development Agreement to Define &Test a Process for Qualifying Preclinical Safety biomarkers

Novartis Pharmaceuticals Corporation announced today the successful completion of a cooperative research and development agreement (CRADA) with the Food and Drug Administration (FDA), one of the first projects conducted under the FDA's Critical Path Initiative.

The Critical Path Initiative was launched by FDA in 2004 to refine the science and processes through which FDA-regulated drugs, biologics, and devices are translated from a discovery or "proof of concept" to a medical product. The research produced under the CRADA led to a number of key achievements that will enhance the development and application of preclinical biomarkers to evaluate drug safety. "In working together with FDA, we have demonstrated the progress that can be achieved in the biomarker field, and in the science of drug development in general, through public-private partnerships," according to John Orloff, MD, Senior Vice President, US Medical and Drug Regulatory Affairs at Novartis Pharmaceuticals Corporation.

"We have developed both a process for defining biomarkers of safety and real-world data that can support regulatory decision making regarding renal safety." The FDA-Novartis CRADA had two primary objectives: 1) To define a process for qualifying preclinical safety biomarkers for regulatory decision making; and 2) to test this pilot process by submitting kidney-related safety biomarkers identified and characterized through preclinical studies to the FDA for qualification. Efforts conducted under the CRADA have resulted in the publication of the first pilot framework for a preclinical regulatory biomarker qualification process(1).

The development of this process will have a broad impact on the understanding of the qualification of safety biomarkers far beyond this partnership. In addition, the preclinical data identified thus far have demonstrated evidence for the superiority of new renal biomarkers over the current standards used to assess renal injury in drug testing, namely serum creatinine and blood urea nitrogen (BUN). Further efforts will focus on the extended clinical qualification of biomarkers that could allow clinicians to detect kidney injury in patients earlier than current clinical practice allows. Relevant safety biomarker data generated by Novartis as part of the CRADA has been shared with the Critical Path Institute's Predictive Safety Testing Consortium (PSTC).

The PSTC is a larger public/private partnership between industry, academia, and regulatory health authorities intended to serve as a neutral body for coordinating activities related to biomarker qualification in drug development. The CRADA data, together with data generated by other partners in the PSTC has been submitted to FDA and the European Medicines Agency (EMEA) as part of a Voluntary Exploratory Data Submission (VXDS). The two regulators are now considering whether to approve use of these biomarker data in support of particular aspects of regulatory decision making. As a result of this data submission,

FDA and EMEA have utilized appropriate internal boards and worked to refine the process to qualify such preclinical safety biomarker data. Further joint evaluation of additional data under the auspices of the PSTC is expected to lead to additional submissions of peripheral biomarkers representing additional renal pathologies. "The Biomarker CRADA is a significant step in bridging the gap between basic scientific research and the medical product development process," said Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research. "The FDA was pleased to work with Novartis to further the development of renal safety biomarkers that can be used to prevent drug-induced kidney damage." The data generated by Novartis under the CRADA will continue to have an impact despite the agreement's conclusion. Novartis intends to submit additional data on genomic- and proteomic-based renal safety biomarkers to FDA and EMEA in the summer of 2008.

Naglazyme Approved by Japanese Ministry of Health

BioMarin Pharmaceutical Inc. announced today that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has received approval for its Marketing Application for Naglazyme(R) (galsulfase) from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with Mucopolysaccharidosis VI ( MPS VI).

"We are proud to work with AnGes in bringing the first drug treatment option to MPS VI patients in Japan," said Stephen Aselage, Senior Vice President of Global Commercial Development at BioMarin. "We are dedicated to providing life-altering therapies to patients around the world and continue to expand our geographic footprint through our patient identification and commercialization efforts."

BioMarin established a marketing and distribution agreement with AnGes in December 2006, through which AnGes obtained exclusive rights to market Naglazyme in the Japanese market. AnGes submitted a marketing application to the MHLW in August 2007. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) in May 2005 and by the European Commission (EC) in January 2006. As the first drug approved for MPS VI, the FDA and EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the United States and 10 years of market exclusivity in the European Union. In addition, Naglazyme obtained orphan designation in June 2007 from the MHLW in Japan.

Suven Life Sciences gets Two product patents in Korea and Mexico

March 31, 2008 – Suven Life Sciences Ltd has announced that two product patents were granted in Mexico and Korea for two of their new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid until 2023.

These granted patents are exclusive intellectual property of Suven and are achieved through the exclusive internal discovery research efforts. Products out of these inventories, which are in pre-clinical development, may be out-licensed at the stage of clinical phase-I or phase-II stage.

"We are very pleased by the issuance of these patents to Suven for our drug candidates that are being developed for CNS disorders which targets an $18 billion potential market opportunity globally" says Venkat Jasti, CEO of Suven.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like attention deficient hyperactivity, Alzheimer's, Parkinson, Schizophrenia and Huntington's.

Endo and Penwest File Lawsuit Against Actavis Relating to Opana ER

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 Actavis South Atlantic LLC in the United States District Court for the District of New Jersey in connection with Actavis's Abbreviated New Drug Application (ANDA) for OPANA(R) ER (oxymorphone HCl) extended-release tablets CII.

The lawsuit is in response to Actavis's notice to Endo and Penwest, announced on February 15, 2008, advising of the filing by Actavis of an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. Actavis's Paragraph IV certification notice refers to four Penwest patents listed in the FDA's Orange Book, which patents cover the formulation of OPANA ER. The complaint filed today alleges infringement of U.S. Patent No. 5,958,456, which is one of these Orange Book-listed patents.

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

Spanish Appellate Court Rules in Pfizer's Favor, Upholds Lipitor Patent

Mar 31, 2008 - Pfizer Inc said today that the Court of Appeal of Barcelona has upheld the company's enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor, reversing the lower court decision. The enantiomer patent expires in July 2010.

The patent was challenged jointly by generic companies Laboratorios Cinfa S.A., Kern Pharma S.L., Laboratorios Alter S.A. and Laboratorios Belmac S.A., and is one of four separate challenges to the enantiomer patent by generic companies in Spain. Lipitor is sold in Spain under the brand names Zarator and Cardyl. "This is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries and for the patients who benefit from those discoveries," said Pfizer Senior Vice President and Associate General Counsel Peter C. Richardson. Cinfa, Kern, Alter and Belmac can seek to appeal the decision to the Supreme Court of Spain

Actavis launches Bupropion Hydrochloride SR in the US; 29 products in Bulgaria in 1Quarter; dry skin range in Romania

31 March 2008 -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the US Food & drug administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately.

Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR® and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR® were US$ 498 million for the 12 months ending December 2007 according to IMS Health data. Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban® and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban® were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.

Actavis Bulgaria launches record 29 products in 1Q Actavis Bulgaria launched 29 new products during the first three months of the year. The company plans to launch a total of 43 new products in Bulgaria during 2008. The newly launched products include Fosinopril HCT (cardiovascular) and Lisinopril HCT (cardiovascular), both of which were first to market in Bulgaria; Irinotecan (oncology), which Actavis has also recently marketed in the United States; Sertraline (antidepressant) and Bicalutamide (oncology). Of the 29 products, 23 are nutritional supplements and products from the Decubal cosmetics line.

Actavis Romania says goodbye to dry skin Decubal, Actavis' complete range dedicated exclusively to dry skin, has been officially launched in Romania. The range comprises 17 products. The products, based on long-term research and clinic testing, are dedicated to cleaning and caring for the face, body, scalp and hair.

Caraco Pharmaceutical Laboratories Ltd. To Market Generic Ethyol

Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched amifostine for injection 500mg on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). This product has been added to Caraco's Paragraph IV marketing agreement with Sun Pharma that was signed on January 29, 2008. Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Ethyol(R), and being the first-to-file an ANDA with a Paragraph IV certification, has a 180-day marketing exclusivity. Sun Pharma is currently involved in patent litigation with MedImmune Oncology, Inc. concerning this product in the U.S. District Court for the District of Maryland.

Amifostine is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. This new product is bioequivalent to Ethyol(R), a registered trademark of MedImmune Oncology, Inc. Ethyol(R) had U.S. sales of approximately $80 million for the 12-month period ended December 31, 2007, according to IMS Data.

Lannett Company Receives FDA Approval for Rifampin Capsules USP, 150 mg and 300 mg

Mar 31, 2008 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Rifampin Capsules in 150 mg and 300 mg, the generic equivalent of Rifadin(R) Capsules marketed by Sanofi Aventis US, LLC.

According to Wolters Kluwer, total sales of generic Rifampin Capsules were $38 million in 2007. Rifampin is indicated in the treatment of all forms of tuberculosis and for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx.

"This approval bolsters our growing portfolio of manufactured pharmaceutical products," said Arthur Bedrosian, president and chief executive officer of Lannett. "We expect to commence marketing both dosages of our Rifampin product in the near term."

Judge Construes Claims In Carbatrol Patent Fight

March 28, 2008--A federal judge (STANLEY R. CHESLER) delivered a mixed ruling in Shire Laboratories Inc.'s patent lawsuit against generics maker Corepharma LLC over Shire's anti-seizure drug Carbatrol, accepting Corepharma's proposed construction of one disputed term and rejecting its constructions of three others.

Shire Laboratories, Inc. and Defendant Corepharma, LLC have filed an application for claim construction to resolve disputes over the construction of four claim terms in U.S. Patent No. 5,326,570 (“the ‘570 patent”).

Court Ordered that

(1) the term “unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), as a single thing or entity that is a constituent or isolable member of a more inclusive whole, being the least part of the whole to have a clearly definable existence separate or different from other parts of the whole; and

(2) the term “immediate release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as a unit, as defined above, which begins to release the carbamazepine upon ingestion; and

(3) the term “sustained release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as a unit, as defined above, which provides for a gradual release of carbamazepine over time in the gastro-intestinal tract; and

(4) the term “enteric release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, 52 F.3d 967, as unit, as defined above, which provides for a delayed release of carbamazepine in the lower gastro-intestinal tract.

Poniard signs agreement with Heraeus for Picoplatin

Poniard Pharmaceuticals, Inc, a biopharmaceutical company focused on oncology, signed an agreement with W. C. Heraeus GmbH for the commercial manufacture and supply of picoplatin active pharmaceutical ingredient (API). Financial terms were not disclosed.

Poniard is investigating picoplatin, the company's lead product candidate, in four clinical trials, including the ongoing pivotal phase III trial in small cell lung cancer, and is developing picoplatin as a potential new platform product for the treatment of solid tumours.

Heraeus is a global, family-owned company active in the businesses of precious metals, sensors, dental and medical products, quartz glass and specialty lighting sources.

"This agreement is a major step forward in the development of picoplatin as a commercial oncology product and to ensure that picoplatin is available to patients and oncologists once FDA approval is obtained," said Ronald Martell, president and chief operating officer of Poniard Pharmaceuticals. "Heraeus is a high-quality partner which will provide Poniard with access to large-scale production, and has the capacity to meet our production and quality goals. They are a leader in the manufacture of pharmaceuticals, precious metals and synthesis chemistry."

Under the agreement, Heraeus will manufacture picoplatin API to meet cGMP requirements, and would be ready to ship commercial quantities of picoplatin by 2009. Heraeus is the current manufacturer of picoplatin API for the company's four ongoing clinical trials.
Picoplatin is a chemotherapeutic agent with an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumours. Picoplatin has been evaluated in more than 750 patients and has anti-tumour activity in multiple indications, with less severe kidney and nerve toxicity than is commonly observed with other platinum chemotherapy drugs.

Poniard is evaluating intravenous picoplatin in an ongoing pivotal phase III trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) with overall survival as the primary endpoint. The company is also evaluating intravenous picoplatin in ongoing phase II clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic colorectal cancer (mCRC). Oral picoplatin is being evaluated in a phase I clinical trial in solid tumours. Picoplatin has not been approved by any regulatory authority for use in humans.

US FDA approves Regeneron's Arcalyst for CAPS treatment

Regeneron Pharmaceuticals, Inc. has received marketing approval from the US Food and Drug Administration (FDA) for Arcalyst (rilonacept) injection for subcutaneous use, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.

Arcalyst is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.

Arcalyst is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS. In the pivotal clinical development program, patients treated with Arcalyst experienced a greater improvement in overall symptom scores than patients treated with placebo. These improvements were sustained over time with continued Arcalyst treatment. The most commonly reported adverse reactions reported with Arcalyst were injection-site reaction and upper respiratory tract infection.

"The approval of Arcalyst represents a major advance in the treatment of CAPS patients," said Hal Hoffman, M.D., Associate Professor, University of California, San Diego and a leading expert on CAPS. "Much-needed treatment will now be available to patients suffering from debilitating CAPS symptoms. I hope that the approval of Arcalyst will also contribute to increased awareness of this rare disease which currently is frequently misdiagnosed and insufficiently treated."

Regeneron expects to launch Arcalyst, its first commercial product, within the next 30 days.

"This approval exemplifies Regeneron's commitment to discover, develop, and commercialize important medicines for patients suffering from serious diseases, such as CAPS. I would like to take this opportunity to thank the clinical investigators and CAPS patients participating in our studies, the FDA, and everyone at Regeneron for their collaborative effort in making Arcalyst available to patients who need it," said Leonard S. Schleifer, M.D., Ph.D., Regeneron's president and chief executive officer. "We recognize that Arcalyst may help address a significant unmet medical need that exists among CAPS patients and are therefore committed to helping these patients obtain access to this new treatment."

Shire, TAP Pharma sign co-promotion agreement for Lialda

Shire plc, the global specialty biopharmaceutical company, announced a co-promotion agreement with TAP Pharmaceutical Products Inc. for Lialda (mesalamine) with MMX technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC).

This three year agreement is for the US only and will add more than 500 additional sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing Lialda primarily to gastroenterologists, a Shire press release stated.

"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."

lialda is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.

"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."

Once-daily Lialda with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.

The TAP sales force will begin detailing Lialda to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.

Lialda is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for ulcerative colitis. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The safety and efficacy of Lialda have been established for up to eight weeks. Lialda is the first new formulation in this class to be approved since 2000.

Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize Lialda in the US, Canada, Pacific Rim and Europe (excluding Italy). Lialda is known as Mezavant XL in the UK and Ireland, and Mezavant elsewhere outside of the US. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.

FDA Issues a Communication about an Ongoing Safety Review Regranex (becaplermin)

March 28, 2008--FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers. This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers.

At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex. Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient.

What does FDA know now about these data?

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate our conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed.

(As per article published on pharmalive.com)

Teva Provides Update on Generic Aricept Litigation

Mar 28, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of New Jersey has granted Eisai's motion for a preliminary injunction related to Teva's tentatively approved 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 injunction is based on Eisai's enforcement of U.S. Patent No. 4,895,841 that Teva has asserted is unenforceable. A trial date has not been set.

Lannett Company Receives FDA Approval for Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg, and 50 mg

Mar 28, 2008 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Bethanechol Chloride Tablets in 5 mg, 10 mg, 25 mg, and 50 mg, the generic equivalent of Urecholine(R) Tablets marketed by Odyssey Pharmaceuticals, Inc.

According to Wolters Kluwer, total sales of generic Bethanechol Chloride Tablets were $60 million in 2007. Bethanechol Chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

"This approval represents an important new addition to our product portfolio and is the result of the hard work and dedication of our employees," said Arthur Bedrosian, president and chief executive officer of Lannett. "We will commence marketing our Bethanechol Chloride product, in the 5 mg, 10 mg, 25 mg, and 50 mg tablets, immediately."

Actavis Receives Approval of Generic Wellbutrin SR and Zyban Tablets in the U.S.

Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately.

Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR(R) and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR(R) were US$ 498 million for the 12 months ending December 2007 according to IMS Health data.

Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban(R) and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban(R) were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.

Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said:

"These approvals further enhance our strength in the area of modified release products and provide valuable options to our customers and patients."

Celgene's Amrubicin granted orphan drug designation by US FDA

Celgene Corporation's Amrubicin has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer.

FDA's Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the United States. Orphan drug designation provides an important economic incentive for the development of new products in the cancer field. US orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, and additional regulatory support for R&D initiatives.

"The decision by the FDA to grant Amrubicin orphan drug designation in this critical area of oncology advances our efforts to deliver innovative therapies to patients in areas of unmet medical need and represents the first such milestone in the area of solid tumour cancers," said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. "We will continue to work diligently with regulators as we advance this promising next generation anthracycline through clinical development."

Amrubicin is a third-generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti-cancer therapies for a variety of solid tumours, including lung and breast cancers.

Amrubicin is currently approved and marketed in Japan for the treatment of small cell lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of the therapy. Dainippon Sumitomo also licensed the US and European rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in 2008.

Patients diagnosed with SCLC each year in the US and EU, approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease.

Singulair (montelukast)- Possible Association Between Use Of Singulair And Behavior/Mood Changes, Suicidality, And Suicide

March 27, 2008-FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair.

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

Novel Oral Anticoagulant Pradaxa (dabigatran etexilate) Approved by the European Commission

27 March 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa® (dabigatran etexilate) in all 27 EU member states. It is anticipated that Pradaxa® will be launched in Germany and the United Kingdom in the coming weeks.

Pradaxa® is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.

Neptune Technologies Patent Granted for Novel Phospholipids in Multiple Diseases and Pharmaceutical Applications

Neptune Technologies & Bioressources Inc. ("Neptune") announces that the European Patent Office (EPO) granted on May 31st 2007 Neptune's composition of matter patent entitled "Natural Marine Source Phospholipids comprising flavonoids, polyunsaturated fatty acids and their applications" (EP01417211B1) and that this patent has now been issued and validated in twenty-four European countries.

This patent is directed to the use of Neptune marine phospholipid and flavonoid compositions as a medicament for the prevention and treatment of multiple chronic health conditions, including coronary artery disease caused by hypercholesterolemia, peripheral vascular disease, neurodegenerative and other cognitive disorders.

"This composition of matter patent is a critical achievement that constitutes a key component for our commercial pharmaceutical development program," said Dr. Tina Sampalis, Chief Scientific Officer of Neptune. "Neptune's mission has always been the development of innovative pharmaceutical ingredients, and this patent is viewed as a vital element towards Neptune's pharmaceutical initiatives. Its enforcement is a major accomplishment and a step forward," she added.

As part of the EPO procedure, within a nine-month period following the date of granting of the European patent, a notice of opposition can be filed in writing with the EPO. In the case of Neptune, oppositions were filed by Norway-based Aker BioMarine and Israel-based Enzymotec. The opposition proceedings are a multi-year (5-7 year) procedure with the potential outcome of maintaining the patent, amending it or, in certain cases, revoking it. According to EPO regulations, the opposed patent is considered and remains granted and enforceable in all countries in which it has been validated. The patent continues to preclude the competition from commercializing products as krill oil containing marine phospholipids in these European countries, providing only the patent holder with the benefit of exclusive commercialization.

Graceway Pharmaceuticals Files False Advertising and Unfair Competition Litigation Against River's Edge Pharmaceuticals

Mar 27, 2008 - Graceway Pharmaceuticals, LLC ("Graceway") today announced that it yesterday filed a lawsuit against River's Edge Pharmaceuticals, LLC ("River's Edge") in the United States District Court for the Northern District of Georgia based on River's Edge's improper sales and marketing practices.

The lawsuit alleges that River's Edge unlawfully promotes its benzoyl peroxide gel and wash products as generically equivalent to - or otherwise substitutable for - Graceway's Benziq(TM) family of products: Benziq LS Gel (benzoyl peroxide 2.75%); Benziq Gel 50 g Tube (benzoyl peroxide 5.25%); and Benziq Wash (benzoyl peroxide 5.25%) (collectively "Benziq"). The lawsuit sets forth claims for False Advertising and Unfair Competition in violation of the federal Lanham Act, as well as claims for common law Unfair Competition and Misappropriation.

Benziq is available by prescription only, and was created for patients with a preference for a hydrating benzoyl peroxide treatment that does not irritate the skin.

Indication:
Benziq is indicated for the topical treatment of acne vulgaris.

Safety Information:
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application.

Otsuka to Pay More Than $4 Million to Resolve Off-Label Marketing Allegations Involving Abilify

Otsuka American Pharmaceutical Inc., the U.S. subsidiary of Japanese pharmaceutical manufacturer Otsuka Pharmaceutical Co., Ltd., has agreed to pay more than $4 million to resolve allegations that it marketed Abilify, an atypical antipsychotic drug, for "off-label" uses, the Justice Department announced today.

Otsuka developed Abilify in Japan and then entered into an agreement with Bristol-Myers Squibb (BMS) to co-promote sales of the drug in the United States. Under the agreement, Otsuka sales representatives worked on sales teams led primarily by BMS sales managers. In September 2007, BMS and the government entered into an agreement resolving allegations that BMS had promoted Abilify for off-label uses.

The Food and Drug Administration (FDA) has approved Abilify to treat adult schizophrenia and bi-polar disorder but has not determined the drug to be safe and effective in the treatment of children and adolescents or in the treatment of geriatric patients suffering from dementia-related psychosis. The FDA has mandated that the package for Abilify carry a "black box" warning concerning its use in the treatment of dementia-related psychosis.

Today's settlement resolves government allegations that, from 2002 through the end of 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis. Otsuka is alleged to have participated in directing its sales force to call on child psychiatrists and other pediatric specialists, with the sales force then urging those physicians and others providers to prescribe Abilify for pediatric patients. Otsuka sales representatives also participated in a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder. Because of the potential market benefit, the long term care sales force promoted Abilify off-label for the treatment of dementia-related psychosis.

From the global civil settlement amount of $4 million, the federal recovery is approximately $2.3 million. Otsuka also will pay approximately $1.7 million to the Medicaid programs in the participating states. Also, as part of today's settlement, Otsuka entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.

This settlement resolves the remainder of the allegations made in a False Claims Act action entitled, Civil Action No. 05-10196-MLW (D. Mass.). The Department of Justice settled claims based on the same allegations with BMS in September 2007.

The False Claims Act allows for private persons to file a or whistleblower suit on behalf of the government. If the government is successful in resolving or litigating its claims, the whistleblower may receive a share of the recovery. The whistleblower, Joseph Piacentile, a physician, will receive a total of approximately $348,000 as his share of the federal recovery amount from today's settlement, and an additional share of the state settlement amount.

This matter was investigated by the Boston offices of the Office of Inspector General for the Department of Health and Human Services, the Federal Bureau of Investigation and the Food and Drug Administration's Office of Criminal Investigations, and was handled by United States Attorney's Office for the District of Massachusetts and the Department of Justice Civil Division.

FDA Announces New Pediatric Dosing Recommendations for Reyataz Capsules, Patients Ages 6 to 18 Years Old

March 26, 2008--The Reyataz (atazanavir) Capsule label has been updated to include the dosing recommendations for pediatric patients 6 to 18 years of age.

REYATAZ should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus (a type of brain damage caused by excessive levels of bilirubin).

BioAlliance Pharma Receives Market Approval for Loramyc in Germany, Belgium and Luxemburg

BioAlliance Pharma SA (Paris:BIO) today announced that it has received three additional Marketing Authorizations under the European Mutual Recognition Procedure for Loramyc(R) in Germany, Belgium and Luxemburg (following on from the first authorizations granted in January in the United Kingdom and Denmark).

Market approval in Germany is another important milestone for BioAlliance Pharma in its Europe-wide commercialization strategy for Loramyc(R) via the dedicated SpeBio(R) subsidiary (a JV with SpePharm). Under the terms of the current licensing agreement, this marketing authorization will earn BioAlliance Pharma a EUR 2 million milestone payment from SpePharm. Milestone payments linked to marketing approval in Germany and the United Kingdom now amount to a total of EUR 4.5 million and will be fully counted in the turnover of Q1 2008. The terms of the agreement include up to EUR 17 million in sales-linked performance milestone payments.

"These new Marketing Authorizations mean that the internationalization of Loramyc(R) is continuing actively within Europe. We are working closely with the regulatory agencies in the remaining countries (Italy, Spain, Ireland, Sweden, Norway, Finland and The Netherlands), which should grant their approval in the very near future. The product availability for patients will depend on price negotiation and reimbursement constraints in each country but are scheduled for 2008 in the United Kingdom and Germany, in particular", commented Dominique Costantini, President and CEO.

Shire and TAP Agree to Co-promote Lialda (mesalamine), the Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis

March 26, 2008 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, announced today a co-promotion agreement with TAP Pharmaceutical Products Inc. for LIALDA(TM) (mesalamine) with MMX(R) technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). This three year agreement is for the U.S. only and will add more than 500 additional sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing LIALDA primarily to gastroenterologists.

"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."

LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.

"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."

Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.

The TAP sales force will begin detailing LIALDA to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.

State of Alaska and Eli Lilly and Company Reach Agreement to Settle Zyprexa Lawsuit

March 26, 2008 /PRNewswire-FirstCall/ -- Eli Lilly and Company and the State of Alaska have agreed on the following joint statement:

Alaska Attorney General Talis J. Colberg and Eli Lilly and Company today announced a settlement of the lawsuit filed by the State of Alaska over use of Zyprexa(R) (olanzapine) by the State's Medicaid program. The trial began March 3, 2008, in Superior Court in Anchorage.
The agreement resulted from ongoing mediation ordered by trial Judge Mark Rindner before the trial began. Presiding Judge Morgan Christen renewed mediation efforts with the parties last week.
The settlement will include payment by Lilly of $15 million plus a term that will ensure that Alaska is treated as favorably as any other state that may settle with Lilly in the future over similar claims.
"I am very pleased with the efforts by Assistant Attorney General Ed Sniffen and our team of trial attorneys," Colberg said. "We believe this is a good result for the State of Alaska and the Department of Health and Social Services," he added.
"We believe this settlement is in the best interest of the company, the State, and, importantly, of the patients, families and healthcare professionals for whom Zyprexa is an important treatment option," said Robert A. Armitage, Lilly's senior vice president and general counsel.
In addition, Lilly provided the following information:
"While we had a strong defense, we agreed with the State that the best result for everyone is an amicable resolution," Armitage said. "A trial always involves significant time and resources, especially a two-phase trial like this one that posed additional legal hurdles. A settlement helps us get back to what we want to focus on as a company: developing important new medications through research and partnerships with doctors and patients.
"We appreciate all the time and energy the jury invested over more than three weeks in such a complex case," Armitage added.
The agreement involves no admission of wrongdoing on Lilly's part.
The March, 2006 lawsuit claimed the State and healthcare providers were insufficiently warned about possible side effects relating to weight gain, high blood sugar and diabetes, causing harm to the State's Medicaid recipients and increased costs to the State. The lawsuit asked that Lilly pay the State for those costs and pay civil penalties under the Alaska Unfair Trade Practices and Consumer Protection Act (UTPCPA).
Prescribed for more than 23 million people since its initial approval by the FDA in 1996, Zyprexa is regularly prescribed in the U.S. and in more than 80 other countries. One of a class of medications called "atypical antipsychotics," it is approved to treat schizophrenia and bipolar disorder.
"Our decision to resolve this case does not change the fact that Zyprexa can continue to improve the lives of patients around the world who are suffering from schizophrenia and bipolar disorder," Armitage said.

Pfizer Sues Ranbaxy To Block Generic Caduet Until 2016

Pfizer Inc. lodged a declaratory judgment suit on Monday claiming that Ranbaxy's proposed generic would infringe two patents related to atorvastatin, in a move that could stop Ranbaxy Laboratories Ltd. from marketing a generic version of the Caduet until 2016.

Pfizer filed its complaint in the U.S. District Court for the District of Delaware, seeking a judgment that Ranbaxy's copycat Caduet would infringe two patents Pfizer says are valid through July 16, 2016. The suit seeks injunctive relief barring Ranbaxy from making, selling or importing its generic until those patents expire.

Pfizer's suit centers on U.S. Patent Numbers 6,087,511 and 6,274,740 — which issued in 2000 and 2001, respectively. Both patents cover methods of making amorphous atorvastatin, Pfizer's complaint said.

The active ingredients of Caduet, which is a combination of the Pfizer drugs Lipitor and Norvasc, are atorvastatin calcium and amlopdipine besylate.

The atorvastatin calcium and amlodipine besylate product contemplated in Ranbaxy's abbreviated new drug application is made by a process that would infringe the '511 and '740 patents, and Ranbaxy's importation and/or future sales of the ANDA product will also infringe the patents at issue, according to Pfizer.

Ranbaxy is looking to market its generic Caduet as soon as it can get FDA approval, Pfizer said.
Ranbaxy notified Pfizer that it had filed an ANDA seeking approval for generic Caduet in January 2007, which led Pfizer to sue Ranbaxy in Delaware in March of that year.

In that suit, Pfizer asserted U.S. Patent Numbers 4,681,893 and 6,455,574. Ranbaxy also brought U.S. Patent Number 5,273,995 into the mix by filing counterclaims alleging that the '995 patent in invalid and unenforceable or not infringed.

In November 2007, the district court in Delaware granted Pfizer's bid for a judgment that Ranbaxy had infringed the '893 patent.

The complaint Pfizer filed Monday notes that the New York-based pharmaceutical giant already won a judgment that enjoined the effective date of approval of Ranbaxy's ANDA Number 78-747 — which seeks the U.S. Food and Drug Administration's permission to make and sell generic Caduet — until the expiration of the '893 patent.

Adding on six months of pediatric exclusivity, to which Pfizer claims to be entitled, extends the exclusivity afforded by the '893 patent through March 24, 2010, the plaintiff claims.

J&J gets approvable letter for Ceftobiprole from US FDA

Johnson and Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), has received an approvable letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.

Dr. Anthony Man, CEO, Basilea said, "We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., to quickly address the questions from the FDA."An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.

The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotic.

J&JPRD, a part of Johnson & Johnson, has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Health Canada approved new treatment for heart failure

March 25, 2008 /CNW/ - Health Canada has approved a leading high blood pressure medicine Diovan* (valsartan) to treat chronic heart failure (HF) in patients who cannot tolerate angiotensin-converting-enzyme (ACE) inhibitors, a common type of heart failure therapy.

Characterized by a progressive weakening of the heart muscle until it no longer pumps blood effectively, HF is the most common cause for adult hospitalizations in Canada and carries a greater risk of death than most cancers.

"Quality of life remains compromised for many heart failure patients since 20% to 50% of these individuals can not tolerate standard therapy," says Dr. George Honos, a staff cardiologist and director of noninvasive cardiology at the Sir Mortimer B Davis Jewish General Hospital in Montreal, Quebec. "The approval of Diovan* is welcome news for this patient population who require additional options to improve survival."

Obesity Drug Market Will Increase More Than Five-Fold, Reaching $2.7 Billion in 2016

March 25, -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the obesity drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan will experience more than five-fold growth, rising from $478 million in 2006 to more than $2.7 billion in 2016. The market will grow most rapidly in the United States, where sales will increase from $222 million in 2006 to nearly $2 billion in 2016.

The new Pharmacor report entitled Obesity finds that the significant market growth will be driven by a number of emerging therapies, including Arena Pharmaceuticals' lorcaserin and Amylin Pharmaceuticals' pramlintide/leptin combination, which are both expected to launch in the world's major pharmaceutical markets by 2011. Lorcaserin, pramlintide/leptin and other emerging novel therapies will capture 80% of the total obesity market in 2016 as physicians switch from the few currently available therapies to new treatments with novel mechanisms of action.

The report also finds that increasing concern of the Food and Drug Administration (FDA) regarding the long-term safety of drug treatments for chronic conditions such as obesity poses one of the most significant threats to companies developing anti-obesity drugs. For example, although Sanofi- Aventis's Acomplia (rimonabant) had been widely anticipated to become a key therapy for obesity, its blockbuster potential was eliminated after a negative opinion of the drug was issued by an FDA advisory panel last year. According to the report, similar safety concerns will plague Merck's taranabant and Pfizer's CP-945598, which belong to the same drug class as rimonabant.

"Given the high prevalence of obesity in the world's major pharmaceutical markets, the opportunity for agents that fulfill the need for safe, effective and well-tolerated weight-loss therapies is significant," said Donny Wong, Ph.D. principal analyst at Decision Resources. "Although the most efficacious emerging obesity drugs are combination therapies with multiple mechanisms of action, most of the late-stage therapies in development lack blockbuster potential because they are either associated with safety concerns or are available only in inconvenient injectable formulations."

Sagent Pharmaceuticals Launches Cefepime Injection

Sagent Pharmaceutical, today announced that it has launched Cefepime for injection, USP, a broad spectrum antibiotic used to treat bacterial infections. Sagent's Cefepime for injection will be available in 1g and 2g single dose vials. According to IMS data, sales of Cefepime in the US in 2006 were approximately $167 million. Sagent will begin marketing and shipping cefepime immediately.

"In the past week Sagent has launched two anti-infective products, each upon the expiration of innovator exclusivity. These launches illustrate both Sagent's capabilities and the depth of our unique worldwide partnerships in effectively developing, obtaining approval for, and marketing a broad range of injectable products," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "The addition of Cefepime to our product portfolio, underscores our commitment to rapidly provide our customers and patients with a strong portfolio of injectable antibiotic products."

The introduction of Cefepime for injection marks the fourth product launch from Sagent's pipeline of more than 200 products. This month, the Company has launched two essential antibiotic products: ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous administration and Cefazolin for injection, USP.

(According to the article published on pharmalive.com)

APP Pharmaceuticals Launches Cefepime Hydrochloride for Injection

March 25, 2008--APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Cefepime Hydrochloride for Injection, the generic equivalent of Maxipime(R) marketed by Elan Corporation, plc. APP's cefepime is AP-rated, bar-coded and latex-free. According to IMS data, sales of Cefepime Hydrochloride in the United States were approximately $173 million in 2007.

Cefepime Hydrochloride for Injection is indicated in the treatment of the following infections: Pneumonia, Empiric Therapy for Febrile Neutropenic Patients, Urinary Tract Infections (including pyelonephritis), Skin and Skin Structure Infections, and Intra-abdominal Infections.

"The launch of Cefepime further bolsters our leadership position as a provider of the broadest portfolio of generic anti-infective injectable products," said Tom Silberg, President of APP. "APP is one of the only marketers of first, second, third and fourth generation cephalosporin in the U.S."

Taro Receives FDA Approval for Ondansetron Hydrochloride Injection USP, 2 mg/mL ANDA

Mar 25, 2008 - Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Injection USP, 2 mg/mL ("Ondansetron Injection").

Taro's Ondansetron Injection is used for the prevention of nausea and vomiting associated with chemotherapy. This new Taro sterile injectable prescription product is bioequivalent to GlaxoSmithKline's Zofran(R) Injection, 2 mg/mL. Taro's Ondansetron Injection will be manufactured in the Company's sterile facility in Ireland. According to industry sources, branded and generic injectable ondansetron products had U.S. sales of more than $150 million in 2007.

Aurobindo to enter Italian generic market

Aurobindo Pharma Ltd has recently concluded a strategic deal, for acquisition of intellectual property and marketing authorizations, with TAD Italy, a generic company registered in Italy.

This acquisition will give Aurobindo an access to more than 70 ready to market products which will fast track Aurobindo's entry into the Italian generic market. This strategic acquisition is expected to jump start the business for Aurobindo in Italy where the market and the regulatory procedures are considered as the one of the toughest in all EU.

"This deal will provide us with a ready local platform and will help us is immediately maximising the potential of our vast internal pipeline which is to follow in the next few months. Aurobindo has already flied 22 products for registration in Italy. During the integration process, we expect to derive maximum synergies from this acquisition by shifting the manufacturing of TAD's products to our own facilities", commented Ashish Menocha, Aurobindo's regional VP, Europe.

Aurobindo has also acquired high profile OTC brands Mapooro (www.mapooro.com) and Carmiooro from TAD as a part of this deal.

This is the company's third acquisition in Europe, after acquiring Milpharm Ltd in UK and Pharmacin International BV, in Netherlands. The company believes that such acquisitions reduce the time to market and enhance the relationships in the generic value chain in addition to building a broad and formidable product portfolio.

MedWatch - B. Braun Heparin Sodium Injection Solutions - Recall due to heparin-like contaminant

March 24, 2008-B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.

SIGA Files Application Supporting Emergency Use Approval for ST-246

Mar 24, 2008 - SIGA Technologies, Inc. (NASDAQ: SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, announced today that it has submitted to the FDA an application to support an Emergency Use Authorization (EUA) of its drug ST-246, an orally active, smallpox antiviral, to treat individuals exposed to the smallpox virus in the event of an outbreak.

The EUA mechanism was created by Congress to enable the FDA Commissioner to authorize the use of a drug that has not been approved, or has not been approved for a particular use, when the nation is in a state of declared emergency. EUA approval is given only to those drugs or products that may be effective in the prevention, diagnosis or treatment of serious or life-threatening diseases or conditions that can be caused by specified biological, chemical, radiological or nuclear agents.

Dr. Eric A. Rose, SIGA's Chief Executive Officer and Chairman, commented, "Opening a dialogue with the FDA regarding EUA status brings us closer to the opportunity for large-scale production and stockpiling of ST-246 to treat individuals with symptomatic smallpox infection. Based on the success to date of our product candidate in trials, we believe that we have the most advanced smallpox treatment in development, and that ST-246 represents the most effective treatment option should a smallpox threat ever arise."

Dr. Rose continued, "One year ago we were asked by the CDC to provide a formulation of ST-246 for treatment of a moribund child with eczema vaccinatum, an illness that mimics clinical smallpox. The FDA approved the compassionate emergency use of ST-246 within hours, and the child recovered after receiving ST-246 along with other medications. We believe that in the event of a smallpox outbreak responsible government agencies will also want to provide ST-246 to patients with clinical signs and symptoms, who otherwise would have an estimated mortality rate of 20 to 30%. Over the past year, we have completed additional animal effectiveness and human safety trials which, in the Company's view, have reasonably defined the adult dose of the drug for this purpose and a safety profile which, we believe, compares very favorably to the natural history of symptomatic smallpox. In addition, we have developed a manufacturing process to create substantial quantities of the drug for stockpiling."

"If the FDA determines that ST-246 is eligible for an Emergency Use Authorization, it will be a major milestone for our Company, facilitating government acquisition of the drug through Project BioShield. As we understand the BioShield requirements, ST-246 must demonstrate a path to FDA approval. Our EUA submission demonstrates, we believe, that ST-246 is progressing well on this path." Whether this or any drug receives Emergency Use Authorization is dependent on many factors, and the submission of an application to FDA provides no assurance that the application will be favorably acted upon by the agency.

The ST-246 project has, in part, been funded with Federal funds from the National Institute of Allergy and Infectious Disease and the Department of Defense's Threat Reduction Agency. The drug has previously shown significant antiviral activity in numerous animal models of orthopoxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus.

Suven Life Sciences Secures Two Product Patents in all Russian Countries (Eurasia Region)

HYDERABAD, India, March 24, 2008 – Suven Life Sciences Ltd (Suven) announces today that two product patents were granted in Eurasia (009193 and 009367) for two of their New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid until 2023. The patents are valid in all contracting countries like Armenia, Azerbaijan, Belarus, Kyrgyzstan, Kazakhstan, Moldova, Russia, Tajikistan and Turkmenistan.

These granted patents are exclusive intellectual property of Suven and are achieved through the exclusive internal discovery research efforts. Products out of these inventions which are in pre-clinical development may be out-licensed at the stage of clinical Phase-I or Phase-II stage.

“We are very pleased by the issuance of these patents to Suven for our drug candidates that are being developed for CNS disorders which targets an $18 billion potential market opportunity globally “says Venkat Jasti, CEO of Suven.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neuro-degenarative disorders like Attention deficient hyperactivity, Alzheimer’s, Parkinson, Schizophrenia and Huntington’s.

Barrier Therapeutics Granted Second Interim Patent Term Extension for Vusion Ointment

Barrier Therapeutics, Inc. (Nasdaq:BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, announced today that the U.S. Patent and Trademark Office (USPTO) has granted a second one-year interim patent term extension to United States Patent Number 4,911,932. This patent covers the Vusion(r) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment formulation and methods of treating diaper dermatitis. This action extends the term of this patent to March 27, 2009. The Company intends to list this extension in the Orange Book published by the U.S. Food and Drug Administration (FDA).

"Vusion is a key brand for Barrier Therapeutics, and we are pleased to receive this second one-year patent term extension from the USPTO as we continue our efforts to secure the full five-year patent term restoration under the Hatch-Waxman Act which, if granted, could protect Vusion to 2012," said Mr. Al Altomari, Chief Operating Officer.

This patent was originally scheduled to expire on March 27, 2007. Barrier Therapeutics has applied for up to five years of patent term extension under the United States Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. This five year application is currently being reviewed by the USPTO, in consultation with the FDA. The interim extension was granted pursuant to a portion of the Hatch-Waxman Act that provides a process for applying for interim extensions of up to one-year at a time, if a patent is scheduled to expire during the review of the application. This second interim grant extends the patent term until March 27, 2009, or until a final determination on the five year application is made, if earlier. Based on the current stage of the review process, the Company does not anticipate a final determination on the five year application prior to March 2009. Accordingly, the Company anticipates that it will request a 3rd interim extension later this year. While the Company has submitted an application for patent term extension until March 2012, it is possible that the USPTO could reject that application or grant an extension for a shorter period of time.

HIV/AIDS Update - Tentative Approval of Two Fixed Dose Combination Products for PEPFAR

On March 20, 2008, the Food and Drug Administration (FDA) granted tentative approval to two fixed-dose combination products containing generic versions of stavudine/lamivudine/nevirapine 30mg/150mg/200mg Tablets, and stavudine/lamivudine/nevirapine 40mg/150mg/200mg Tablets, under expedited procedures for the President's Emergency Plan for AIDS Relief (PEPFAR) program. Both fixed dose combinations are manufactured by Strides Arcolab Limited of Bangalore, India, and indicated for the treatment of HIV-1 infection.

Each ingredient of this generic tablet is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination of stavudine/lamivudine/nevirapine in lowering viral load and increasing CD4+ cells has been demonstrated in previously conducted controlled studies of the individual ingredients used together.

Combination products such as these can significantly reduce pill burden. potentially resulting in improved therapeutic compliance with complex dosing regimens, as well as facilitating the storage and distribution of these HIV medications.

FDA's "tentative approval "means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the PEPFAR program.

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.

These products were reviewed under the FDA guidance titled "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV" developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.

Merck's cervical cancer vaccine Gardasil gets US FDA priority review

Merck & Co., Inc. said the US Food and Drug Administration (FDA) has accepted, and designated for priority review, the supplemental Biologics License Application (sBLA) for Gardasil [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] for the potential use in women aged 27 through 45. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA's goal is to review and act on 90 percent of BLAs designated as priority review within six months of receipt.

Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. Women remain at risk for newly acquired HPV infections and developing HPV-related diseases throughout their lifetime.

Gardasil is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. It is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). Gardasil has not been shown to protect against disease due to other HPV types.

In clinical studies for Gardasil, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 per cent among recipients of Gardasil and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.

Sun Pharmaceutical Announces USFDA Approval to Market Generic Tessalon

MUMBAI, March 21, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Forest Lab’s Tessalon®, benzonatate capsules.

Benzonatate USP capsules are therapeutically equivalent to Forest Lab’s Tessalon®, and are available in two strengths: capsules containing 100 mg and 200 mg benzonatate USP.

Benzonatate has annual sales of approximately USD 40 million in the US. Benzonatate is an antitussive, used to relieve cough due to the common cold, bronchitis, pneumonia, or other lung infections. This product will reach market shortly.

Federal Court of Appeal in Canada Upholds Lipitor Enantiomer Patent, Decision Prevents Launch of Generic Product by Ranbaxy until 2010

Mar 20, 2008 - Pfizer Inc said today that the Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy Laboratories Limited from obtaining approval for a competitor product to Lipitor. The appellate court issued an order prohibiting regulatory approval of Ranbaxy's product in Canada until Pfizer's enantiomer (calcium salt) patent--Canadian Patent No. 2,021,546--expires in July 2010.

"This decision sends a strong signal about the importance of protecting intellectual property in Canada, which provides the incentive for research-driven pharmaceutical companies to make the significant high-risk investments necessary to develop new life-saving medicines," said Pfizer Senior Vice President and Associate General Counsel Peter Richardson. "The court's ruling is not only an important one for Pfizer, but also for patients."

Ranbaxy may seek a review of the decision by the Supreme Court of Canada.

Federal Circuit Addresses Effect of 271(e)(1) "Safe Harbor" in ITC Actions

Amgen holds at least six US patents that relate to erythropoeitin and its derivatives (“EPO”) and processes for making EPO, protecting the Amgen drugs Aranesp and Epogen. Sales of Aranesp alone topped $3.6 million last year. Roche produces EPO in Europe and has been seeking FDA approval for its own EPO drug, Mircera, in the US.

Roche began importing EPO as part of its effort to generate data for its regulatory submissions to the FDA. Amgen did not object to these acts of importation. However, Roche continued importing EPO even after its FDA application was complete (though Roche has not yet sold or contracted to sell any of its EPO in the US). Amgen responded by filing a Section 337 action with the International Trace Commission (ITC), asking the ITC to enjoin Roche’s further importation and future sale in the US of its European-produced EPO.

The ITC denied Amgen’s injunction request because (1) the ITC determined that Roche’s importation of EPO was protected by the FDA “safe harbor” provision of Section 271(e)(1), which provides that conduct cannot infringe a patent when it is reasonably related to securing FDA approval; and (2) the ITC has no jurisdiction absent a sale or contract for sale of EPO in the US. In a decision Wednesday, the Federal Circuit affirmed in part, reversed in part, and remanded the case to the ITC.

Amgen made three arguments on appeal: (1) Section 271(e)(1) provides no exemption for the importation of articles made overseas by patented processes in Section 337 actions before the ITC; (2) Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct; and (3) the ITC has jurisdiction whenever sale of the accused article is imminent. All three Federal Circuit panelists sided with Amgen on the second and third points. On the first point, however, Judges Newman and Lourie agreed with the ITC, while Judge Linn dissented to express his agreement with Amgen’s argument.

On Amgen’s first point, the majority accepted the ITC’s argument, i.e., that the Section 271(e)(1) safe harbor should operate identically in ITC litigation as in federal district court litigation. The importation of an article made by an infringing process constitutes an act of infringement under Section 271(g). But the safe harbor of Section 271(e)(1) holds that certain acts related to gaining regulatory approval are not acts of infringement. Therefore, 271(e)(1) cuts back on 271(g) by declaring that certain types of conduct do not constitute infringement. The ITC, however, does not look to Section 271(g) for its authority. Instead the ITC looks to 19 USC § 337(a)(1)(B)(ii), which declares unlawful the importation of any article “made . . . by means of a process covered by the claims of a valid and enforceable United States patent.” In contrast, Section 271(g) only forbids the importation of articles made by means of a process that infringes the claims of a valid and enforceable US patent. Because the safe harbor of Section 271(e)(1) only addresses infringement, Judge Linn (in dissent) argues that the safe harbor applies to infringement liability under Section 271(g) but not to unlawful trade practices under Section 337(a)(1)(B)(ii). The majority’s holding elects to gloss over these key differences between Section 271(g) and Section 337.

On the other hand, the majority’s holding probably does comport more closely with the policy rationales that support having the regulatory safe harbor. As the majority notes, the legislative history supports this proposition that the 271(e)(1) safe harbor applies identically to importation under Section 271(g) and to importation under Section 337(a)(1)(B)(ii). Moreover, the Supreme Court’s broad reading of the scope of the regulatory safe harbor in Integra v. Merck and Eli Lilly v. Medtronic lends further support for the majority’s policy judgment. Judge Linn even agrees that the majority reaches the policy outcome that makes the most sense. Nevertheless, the text of Section 337(a)(1)(B)(ii) is clearly at odds with such a policy outcome.

On Amgen’s second point, the Court agreed with Amgen. The safe harbor of Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct. For each separate act, the accused party must demonstrate that each act is reasonably related to gaining regulatory approval. Amgen asserted that Roche continued importing EPO after its FDA application was complete and used the imported EPO to conduct marketing studies. The Court remanded the case to the ITC for an act-by-act evaluation of whether Roche’s conduct was indeed within the ambit of Section 271(e)(1).

On Amgen’s third point, the Federal Circuit held that the ITC jurisdiction is invoked “[w]hen it has been shown that infringing acts are reasonably likely to occur . . . .” The court went to great lengths to point out that this standard is not new, and is, in fact, consistent with nearly three decades of ITC precedent. Because Section 337 provides for a prospective remedy, it makes no sense for the complainant to wait for an actual sale to occur, so long as an actual sale is imminent.

The link for decision is as follows: http://www.cafc.uscourts.gov/opinions/07-1014.pdf
(As per the article published on Orange book Blog)

Happy Holi

Dear Subscribers and Viewers

I wish all of you a very Happy Holi. Holi is a festival of colors and I wish this festival will add colors to your life.

Thanks for your kind support.
Amit

Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia

Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA(R) (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease. The American Cancer Society estimates that more than 15,000 new cases of this rare disease will be diagnosed in the United States this year. The TREANDA application as a CLL treatment received priority review from the FDA and was approved within six months of the September 2007 submission. Cephalon anticipates that TREANDA will be available to physicians and patients as a CLL treatment in the United States in April 2008.

Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients

Baxter Healthcare Corporation announced today the U.S. Food and Drug Administration (FDA) approval of ARTISS (Fibrin Sealant (Human)), the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. ARTISS was developed using Baxter's proven fibrin sealant technology platform and is the newest agent in the company's expanding BioSurgery portfolio.

ARTISS allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds, relative to rapid-setting fibrin sealants, which set in five to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. Baxter will launch ARTISS at the American Burn Association (ABA) 40th Annual Meeting held April 29 -- May 2, 2008 in Chicago.

"ARTISS is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts," said Ron Lloyd, general manager, BioSurgery. "This is another example of Baxter's scientific leadership in specialty biologic products, serving needs of patients and physicians."

The FDA approval is based on Phase III study results, which were also published in the March/April 2008 issue of The Journal of Burn Care and Research. The multi-center, prospective, randomized, controlled and blinded study compared the use of ARTISS to staples in 138 burn patients requiring skin grafting. ARTISS is safe and effective for attaching skin grafts with outcomes as good as staple fixation.

Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.

ARTISS is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. It will be available in two forms: a pre- filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, thus enabling application in a thin and even layer.

Perrigo Company Announces Launch of Clobetasol Propionate Foam

Perrigo Company today announced that the United States District Court for the District of New Jersey has denied Connetics Corporation's motion for a preliminary injunction related to Perrigo's Clobetasol Propionate Foam, the AB-rated generic equivalent to Connetics' Olux(R) Foam and has lifted the temporary restraints that have prevented Perrigo from launching the product. The Court also denied Perrigo's motion for Summary Judgment based on non- infringement. The case will now proceed to trial with the trial date not having been set.

With the temporary restraints lifted, Perrigo has commenced launching the product. As the first filer, this commences its 180 days of generic exclusivity.

Perrigo's Chairman and CEO Joseph C. Papa stated, "We are excited about the launch of Clobetasol Foam, which reflects our on-going efforts to make quality healthcare more affordable for our customers."

Clobetasol Propionate Foam is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008.

Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections

Arpida Ltd. today reported that it has submitted a New Drug Application (NDA) in an electronic format for intravenous iclaprim for the treatment of complicated Skin and Skin Structure Infections (cSSSI) to the US Food and Drug Administration (FDA). Arpida has requested a Priority designation for the review of the NDA. Iclaprim is a synthetic diaminopyrimidine which exhibits a rapidly bactericidal action against an extended spectrum of pathogens, including multidrug-resistant bacteria.

The iclaprim NDA contains data from 15 clinical studies, including two adequate and well-controlled multinational pivotal Phase III trials (ASSIST-1 and ASSIST-2, in which approximately 1,000 patients were enrolled and treated). Patients enrolled in both Phase III trials exhibited high incidences of methicillin-resistant Staphylococcus aureus (MRSA). In these two independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint. In the studies, iclaprim was well-tolerated with a safety profile which was compatible with treatment of patients with cSSSI.

Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are convinced that iclaprim - if approved - has the properties to become a successful drug in the hospital antibiotics market. In this market there is a clear need for novel therapies, as several of the currently available drugs are faced with reduced efficacy, emerging resistance or worrying side effects."

Dr Khalid Islam, President and CEO of Arpida Ltd. added: "We're very proud of reaching this important milestone. Arpida has successfully progressed iclaprim from an early preclinical stage all the way to regulatory filing. This achievement is a credit to our team at Arpida as well as to our external partners. We look forward to working closely with the FDA on their review of our submission."

In addition to the cSSSI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II. Moreover, an oral formulation of iclaprim is currently in Phase II clinical trials as a potential step-down therapy following initial intravenous treatment.

Sirtris Announces First U.S. Patent Issued On Class of SIRT1 Activators; Patent Covers First NCE to Enter Human Clinical Trials

March 19, 2008 - Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, announced today that the United States Patent Office issued to Sirtris the first patent covering a broad class of compounds that activate the enzyme SIRT1. Several Sirtris compounds--or new chemical entities (NCEs)--from this class lower glucose and improve insulin sensitivity in preclinical models of Type 2 Diabetes. The patent covers the first NCE that Sirtris plans to take into a human clinical safety trial in the first half of 2008.

"Just five months ago in the publication Nature, we reported the identification of new chemical entities that lower glucose and improve insulin sensitivity in preclinical models that the FDA--in recent draft guidance--recommended for the development of Type 2 Diabetes drugs," says Christoph Westphal, M.D., Ph.D., Chief Executive Officer and Vice Chair of Sirtris Pharmaceuticals. "We are very pleased to have the first patent covering a class of compounds that have the potential to be a frontline therapy for Type 2 Diabetes."

"Sirtris has a strong intellectual property program with over 180 patent applications for broad coverage of sirtuin activators, including composition of matter, formulations, and methods of treatment claims," says Karl Normington, Ph.D., Senior Director of Intellectual Property at Sirtris Pharmaceuticals. "This is the first patent issued by the U.S. Patent Office covering a class of compounds known to activate SIRT1."

In 2006, consecutive papers in the journals Cell and Nature by Sirtris scientists and Sirtris co-founder David Sinclair, Ph.D. of Harvard Medical School, showed that resveratrol, a SIRT1 activator found in red wine, could reduce the impact of a high fat diet, increase stamina two fold and significantly extend lifespan of mice. However, it is estimated that a person would need to drink roughly 1000 bottles of red wine per day to obtain the equivalent dose of resveratrol used in these studies. Sirtris has developed SIRT1 activating molecules that are chemically distinct from, and up to 1000 times more potent in in-vitro studies than resveratrol.

The sirtuins are a family of seven enzymes that help regulate the body's natural defense against disease. In preclinical research, members of the sirtuin family have been shown to have protective effects against various diseases such as Type 2 Diabetes, metabolic diseases, cardiovascular disease, neurodegeneration, inflammation and cancer. Future sirtuin therapeutics may have the potential to treat diseases of aging in a new way.

Sagent Pharmaceuticals Launches Ciprofloxacin Injection, USP, 5% Dextrose Premix Bag

March 19, 2008 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company today announced that it has launched ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous (I.V.) administration used to treat bacterial infections. Sagent's ciprofloxacin injection will be available immediately in 200mg and 400mg premix bags. According to IMS data, sales of injectable ciprofloxacin in the United States in 2006 were approximately $60 million.

"We are poised to be one of the first companies to make the I.V. form of this important antibiotic widely available to patients in the U.S.," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "The launch of our ciprofloxacin -- in ready-to-use, customer friendly, barcoded I.V. bags -- simultaneous with the expiry of the innovator's patent exclusivity further demonstrates Sagent's capabilities and expertise in injectable pharmaceutical products and our seasoned management team's commitment to the needs of patients and customers."

Ciprofloxacin is the third product introduced from Sagent's pipeline of more than 200 products since the launch of the company's first product, adenosine injection, USP, in December 2007. Earlier this month, the company launched another antibiotic, cefazolin for injection, USP, which is available in 1g single dose vials and 10g pharmacy bulk package vials.

Sun Pharmaceutical announces USFDA approval to market generic Cerebyx

March 19, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Parke Davis’s Cerebyx®, fosphenytoin sodium injection.

This fosphenytoin sodium injection USP, 50 mg PE*/ mL, is therapeutically equivalent to Parke Davis’s Cerebyx®, and is available in two packs: 100 mg PE*/ 2 mL and 500 mg PE*/ 10 mL single dose vials. (PE*= Phenytoin sodium equivalents).

Fosphenytoin sodium injection has annual sales of approximately USD 15 million in the US.

Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery.

Strides Arcolab receives its third injectable ANDA approval for Fosphenytoin Injection 50mg/mL

March 19, 2008-Strides Arcolab, one of India's largest exporters of branded generic pharmaceutical products, today announced its third ANDA approval for Fosphenytoin Injection 50mg/mL in 2 ml and 10ml vials.

The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc [NASDAQ: AKRX] and Strides Arcolab Limited [NSE: STAR, BSE: 532531]


Fosphenytoin is the third approval amongst 22 sterile submissions the Company has submitted with US FDA.


Mr.Arun Kumar - Vice Chairman and Group CEO of Strides Arcolab stated: "We are excited with our third sterile injecatable approval and are delighted having achieved a key milestone in creating a global sterile injectable business"

Teva Introduces Ciprofloxacin Injection, USP (In 5% Dextrose)

March 18, 2008 – Teva Health Systems is pleased to announce the introduction and availability of Ciprofl oxacin Injection, USP (In 5% Dextrose). This product is AP rated to Cipro®* I.V. for Intravenous Infusion. Ciprofl oxacin Injection is available in 2 mg/mL, 200 mg and 2 mg/mL, 400 mg in fl exible plastic containers.

“Teva offers a broad range of quality health systems generics from a single source,” states Jonathan Zalk, Director of Marketing. “We are pleased to announce this latest addition to our growing line.”

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.

Immunomedics' Milatuzumab Receives FDA Orphan Drug Designation for Therapy of Multiple Myeloma

March 18, 2008 (PRIME NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to milatuzumab for the treatment of multiple myeloma.

The designation allows the Company to have a seven-year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include waiver of Prescription Drug User Fee Act (PDUFA) filing fees, tax credits for the costs of clinical research, and assistance in clinical research study designs.

"We are pleased to receive Orphan Drug designation for milatuzumab. Preclinical studies by us and other scientists have shown that milatuzumab inhibits the growth of human multiple myeloma and lymphoma cells in culture and in mouse models, and blocks the over-expression of CD74 in chronic lymphocytic leukemia cells, which leads to increased cell death. We have initiated Phase I/II studies to evaluate the therapeutic potential of milatuzumab in patients with multiple myeloma, non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL)," commented Cynthia L. Sullivan, President and CEO.

In addition, John P Leonard, MD, Professor of Medicine at Weill Medical College of Cornell University, is conducting a Phase I study in patients with recurrent NHL or CLL funded in part by a grant from the National Cancer Institute.

FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections

March 18, 2008 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.

An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.

Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe

March 18, 2008 /PRNewswire/ -- Centocor, Inc. and Schering-Plough Corporation announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase 3 development programs are unprecedented among anti-tumor necrosis factor (TNF)- alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states. Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Pending regulatory approval in the European Union, Schering-Plough Corporation will assume exclusive marketing rights for golimumab in Europe.

"We look forward to working with the EMEA so that patients and physicians might one day have the opportunity to experience golimumab as a therapeutic option for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008."

Phase 3 primary endpoint study findings from the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial were reported at the of Rheumatology Annual Scientific Meeting in November 2007. Phase 3 study findings evaluating the efficacy and safety of golimumab in the treatment of more than 1,400 adults with moderate to severe rheumatoid arthritis will be presented at the European League Against Rheumatism Annual Congress in June 2008.

OSI Pharmaceuticals Announces That the Prior Revocation of Its European DP-IV Patent Has Been Upheld

Mar 18, 2008 - OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the decision of the European Patent Office (EPO) to revoke one of the Company's dipeptidyl peptidase IV (DP-IV) patents, EP0896538, claiming the use of DP-IV inhibitors to treat type II diabetes and related indications, has been upheld in appeal proceedings brought by the Company.

"We are disappointed with the outcome of the appeal proceedings. However, since the revocation applies to only one patent within our licensed DP-IV patent portfolio, any short-term loss in royalty revenue in Europe should be mitigated as additional licensed patents within the portfolio progress through the EPO examination procedure to grant," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. "The Company's DP-IV patent estate includes licensed rights to patents and patent applications claiming combinations of DP-IV inhibitors with other oral anti-diabetes drugs such as metformin."

"The Company anticipates that the vast majority of DP-IV sales in 2008 and 2009 are likely to take place in the US, therefore the financial implications of losing this patent in Europe are relatively insignificant and do not impact our prior DP-IV revenue guidance for 2008," stated Michael G. Atieh, Executive Vice President and Chief Financial Officer.

Background

OSI through its U.K. subsidiary, Prosidion Limited, owns or has licensing rights to issued and pending patents and patent applications with claims covering DP-IV as a target for anti-diabetes therapy and related indications. The patents which are subject of these DP-IV licenses will expire between 2017 and 2019. Thirteen pharmaceutical companies, including Merck & Co., Inc., Novartis AG and Bristol-Myers Squibb Company have taken licenses to this patent estate.

Hi-Tech Pharmacal Receives Final Approval for Ofloxacin Otic Solution

Mar 18, 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 Ofloxacin otic solution, 0.3%. Hi-Tech's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin(R) otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2007, had sales of $105 million according to IMS.

Are generics safe and effective as Brand name Drugs?

The Los Angeles Times is serving up a package of stories this morning questioning whether generic drugs are as good as the brand-name medications they copy.

The Times cites complaints about a variety of generics, including drugs for epilepsy, depression and the heart. It tells the story of patients like Jillian Bealer, of Buffalo, N.Y., who’d been taking antidepressant Wellbutrin XL for attention deficit disorder and an anxiety disorder. But after switching to a generic, her mental health deteriorated. While the FDA defends its generic-drug approval practice and says it’s confident generics are equivalent to brands, the Times quotes a number of doctors who say they’re not convinced.

Like Times, we found that both doctors and patients felt passionately that generics weren’t always up to mark. But despite lots of searching, we couldn’t find a solid, randomized and well-controlled study proving there was a problem. The Epilepsy Foundation and allied doctors acknowledged they didn’t have one either.

My own thinking says generics are good enough as branded products.

Today's Question: Do you think that Generics are good enough as Branded products w.r.t safety or efficacy? Please comment.

Neurochem Withdraws Its Marketing Authorisation Application for Kiacta (eprodisate disodium)

March 17, 2008-The European Medicines Agency (EMEA) has been formally notified by Neurochem Luxco II SARL of its decision to withdraw the application for a centralised marketing authorisation for the medicine Kiacta (eprodisate disodium) capsules.

Kiacta was expected to be used for the treatment of amyloid A amyloidosis, a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.

The application for marketing authorisation for Kiacta was submitted to the EMEA on 4 September 2006. The Agency’s Committee for Medicinal Products for Human Use (CHMP) had given a negative opinion recommending the refusal of the marketing authorisation on 13 December 2007. The company had requested a re-examination of the negative opinion. The re-examination had not yet finished when the company withdrew.

In its official letter, the company stated that the withdrawal of Kiacta was based on the request by the CHMP for an additional placebo-controlled study, which the company is not able to provide within the timeframe allowed by the centralised procedure.

More information about Kiacta and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.

Abraxis Bioscience Announces Filing of Marketing Application in Japan for Abraxane in the Treatment of Breast Cancer

Mar 17, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that its partner, Taiho Pharmaceutical Co., Ltd., has filed a Japanese New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare in Japan to market ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer. ABRAXANE is the first and only approved protein-bound nanometer-sized solvent-free taxane and is the first commercial product to validate Abraxis' proprietary nab(TM) technology platform.

"The J-NDA application is an important milestone as we broaden the use of ABRAXANE on a global basis," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "This submission in Japan was the result of close collaboration between the Taiho and Abraxis development teams, and followed the completion of phase I bridging studies in Japan."

ABRAXANE is now approved in Europe, the U.S., India and Canada, encompassing a total of 33 countries. ABRAXANE also is under active review in Australia, Russia, Korea and China by their respective regulatory agencies.

The submission in Japan includes four clinical studies that were part of the original New Drug Application in the United States, including the randomized, pivotal Phase 3 multicenter, comparative study of 460 women with metastatic breast cancer conducted by Abraxis and published in the Journal of Clinical Oncology. This randomized trial compared ABRAXANE at a dose of 260 mg/m2 given as a 30-minute infusion without pre-medication versus solvent-based paclitaxel injection (Taxol(R)) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine pre-medication. The Phase 3 study demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival in the approved indication, and showed comparable tolerability versus Taxol. Additionally, the submission in Japan included several subsequent Phase I and Phase 2 studies, including two conducted by Taiho.

Abraxis BioScience has entered into a license agreement with Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Pharmaceutical Co. Ltd., under which it granted to Taiho the exclusive rights to develop, market and sell ABRAXANE in Japan. A joint committee also was established to oversee the development of ABRAXANE in Japan for the treatment of breast, lung and gastric cancer and other solid tumors. The market for chemotherapy agents in Japan is estimated at approximately $2.6 billion in 2007.

Takeda Submitted a New Drug Application for a Fixed Dose Combination Tablet of Blopress with Diuretic in Japan for Treatment of Hypertension

March 17, 2008 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it submitted a New Drug Application of a fixed dose combination tablet of Blopress® (generic name: candesartan cilexetil) and diuretic (generic name: hydrochlorothiazide) for treatment of hypertension to the Ministry of Health, Labour and Welfare in Japan.

Discovered by Takeda, Blopress is an angiotensin II[*] receptor blocker (“ARB”), which was launched in 1999 and became the first ARB with an indication of Chronic Heart Failure in Japan. Hydrochlorothiazide is classified as a thiazide diuretic and lowers the blood pressure by increasing the flow of urine, which results in volume depletion. It is considered that there is a synergistic anti-hypertensive effect by concominant therapy of ARB and diuretic.

[*] Angiotensin II is known as one of the potent vasopressor hormones.

“We believe that the fixed dose combination tablet of Blopress with diuretic will be able to offer the better control of blood pressure,” said Masaomi Miyamoto, Ph.D., general manager of Pharmaceutical Development Division of Takeda. “We expect that this New Drug Application lead to maximization of added value of Blopress.”

Takeda is persuing every possiblity of fixed dose combination for its product line, which will contribute to the patient’s improved compliance. Currently, the fixed dose combinations of; Actos® (generic name: pioglitazone HCl) which is a member of the thiazolidinedione class of "insulin-sensitizing" agents with sulfonylurea ?generic name: glimepiride HCl?, and Actos with biganide (generic name: metformin HCl) are being marketed in overseas.

Tianyin Pharmaceutical Announces SFDA Approval to Market Azithromycin Dispersible Tablets

Tianyin Pharmaceutical, Co., Inc., , a manufacturer and supplier of modernized traditional Chinese medicine (''TCM'') based in Chengdu, China, today announced that the Company has been granted SFDA approval and is scheduled to launch Azithromycin Dispersible Tablets in the domestic market on April 15, 2008.

The manufacturing license for Azithromycin Dispersible Tablets is not only the first one Tianyin has received but also the first drug approval SFDA has granted to Sichuan Province in 2008. This is the third generic western medicine to be included in Tianyin's product portfolio. The Company will continue to diversify its TCM products, with additional western medicines as they receive approvals for the 10 drugs that are currently in the SFDA pipeline.

Azithromycin is highly effective in treating upper and lower respiratory tract infections and other bacterial infections in skins and reproductive system. Ever since the drug's first introduction, its sales have been growing steadily. Worldwide sales have grown from US$ 619 million in 1996 to $2.01 billion in 2003, representing a 32.6% growth over the previous year. Azithromycin has become a blockbuster product and is now among the TOP 50 prescription drugs in terms of global sales. It is estimated that approximately $350 million in total Azithromycin sales were generated in China during 2007.

''We are pleased to have the first of our pipeline products approved by the SFDA and believe that the launch of Azithromycin provides the opportunity for significant growth in both sales revenue and net profit in the coming years,'' stated Dr. Guoqing Jiang, Chairman and CEO.

The largest domestic distributor of Azithromycin, Anhui Huayuan Pharmaceutical Co., Ltd. is currently one of Tianyin's top strategic partners and has awarded the Company a $3.66 million distribution contract for 2008 covering most of the PRC for Azithromycin and other products. Margins associated with this product are in line with the Company's blended average during the past year. This collaboration will help speed the market entry of Tianyin's Azithromycin Dispersible Tablets and enable the Company to leverage its National SFDA manufacturing approval to gain market share throughout China.

Anesiva submits sNDA to US FDA to expand indication for Zingo

Anesiva, Inc. has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) to expand the indication for Zingo to treat the pain associated with peripheral IV insertions and blood draws in adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system is already approved by the FDA to provide local analgesia prior to peripheral IV insertions and blood draws in children three to 18 years of age.

The sNDA submission is based on results of a multi-centre, randomised, double-blind study in 699 adult patients, which demonstrated less procedural pain associated with blood draws or IV cannulations in those treated with Zingo compared to placebo. Of the study participants, 348 patients received placebo and 345 received Zingo one to three minutes before undergoing medical procedures requiring venipuncture or IV line placement at the back of hand or antecubital fossa (crux of the elbow). The primary endpoint was pain upon needle insertion, utilizing the VAS pain scale. The mean pain score in the Zingo-treated patients was significantly lower than in the placebo group (p = 0.003).

Demographic characteristics and sites of administration were evenly distributed across treatment groups. Zingo was found to be well tolerated in this patient population. The most common skin assessment findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. The incidence of adverse events with Zingo was no higher than with placebo.

"The initial commercial thrust for Zingo is in the paediatric setting, where we have focused our marketing efforts and have an experienced sales force already in place in advance of the planned commercial availability of Zingo in the second quarter of 2008," said John P. McLaughlin, chief executive officer, Anesiva. "Filing the sNDA for Zingo in adults represents another key milestone in Anesiva's efforts to expand and accelerate the growth of Zingo, and potentially offers a solution for adults concerned about pain associated with venous access procedures."

Peripheral venous access procedures are among the most common procedures performed at a hospital, with more than 400 million performed each year in US hospitals on adults. More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre-surgery procedures.

Zingo is an easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder to provide topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws. Zingo's rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. In clinical trials, the most common adverse events with Zingo were redness, red dots and swelling.

Glenmark launches Clobetasol products in US

Glenmark Pharmaceuticals Inc (GPI), the US subsidiary of Glenmark Pharmaceuticals Limited, one of the world's leading, integrated specialty pharmaceutical and high-quality generic companies, has commenced marketing and distribution of five Clobetasol Propionate dermatology products in the US market.

The company has acquired the US marketing rights for a line of Clobetasol Propionate products which include - cream, E cream, ointment, gel and topical solution through an US-based pharmaceutical development company, a company press release said.

Clobetasol Propionate is used to treat diseases such as eczema and psoriasis, where it is used on the scalp and body. It is also dispensed to counter auto-immune presentations, such as Alopecia areata (hair loss due to auto-immune diseases) and Lichen planus (auto immune skin nodules). The total sales for the five above mentioned Clobetasol Propionate products in the 12 month period ending December 2007 were in excess of USD 28 million, as per the IMS Health report.

This dermatology portfolio marks Glenmark's entry into the US semisolid product market. The company plans to launch an additional 11 dermatological products in the next 12 months.

Based on these recent launches, GPI now has a portfolio of 28 generic products for the US market. The company currently has over 35 ANDAs undergoing US FDA approval process/launch.

Sun Pharma gets US FDA nod for generic Ethyol

Sun Pharmaceutical Industries Ltd. said the US FDA has granted approval for its Abbreviated New Drug Application (ANDA) to market a generic version of MedImmune's Ethyol, amifostine for injection 500mg.

This generic amifostine for injection, used as an adjuvant in cancer treatment, is therapeutically equivalent to MedImmune's Ethyol amifostine for injection 500mg. Ethyol has annual sales of approximately USD 80 million in the US.

Sun Pharma, being the first-to-file an ANDA for generic Ethyol with a para IV certification, has a 180-day marketing exclusivity.

Ethyol is covered under 3 patents - '471 (July 31, 2012), '731 (July 31, 2012) and '409 (Dec 8, 2017). This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the District Court of Maryland and the case is under litigation.

Sun Pharma's amifostine for injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.

Eisai Submits Application for Aricept Oral Jelly Formulation in Japan

TOKYO, March 14, 2008-Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that the company submitted an application for a new oral jelly formulation of Aricept® (donepezil hydrochloride) in Japan. If approved, it will become the first Alzheimer's disease treatment available in an oral jelly formulation in the world.

Generally, Alzheimer's disease affects eldery population, and there are some patients who have difficulty swallowing a tablet or granule formulation with water due to the decline in their ability to swallow or the water enters into their trachea while taking the medication. For the patients with such problems, the new jelly formulation will make it easier to administer with the soft and jelly-like texture which can be taken without water. In addition, it can be devided with a spoon into an appropriate volume depending on the patient's ability to swallow, which reduces the burden of caregivers who help their patients take the medication.

Aricept®, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd., is the only approved prescription medicine for the treatment of Alzheimer's disease in Japan. It is believed to work by inhibiting the hydrolysis of acetylcholine, thereby increasing available levels of this neurotransmitter in the brain. It is estimated that there are approximately 1.25 million people with Alzheimer's disease in Japan, and the number is set to increase every year as the aging of the society is progressed.

In Japan, Aricept® is available in tablets, fine granule, and orally rapid disintegrating tablets. Through the addition of the new oral jelly formulation of Aricept® that helps patients adhere to taking medications appropriately, Eisai will continue to make contributions to improving the quality of life of Alzheimer's disease patients, their families and caregivers.

Cellectis Sues Precision BioSciences for Infringement of its Patents Concerning Meganuclease Technology

March 13, 2008 /PRNewswire-FirstCall/ -- Cellectis SA , a world leader in rational genome engineering, has announced today that it filed a patent infringement lawsuit against Precision BioSciences, Inc. in the United States District Court for the Eastern District of North Carolina. The lawsuit seeks a declaration that, by making and selling certain meganucleases, Precision BioSciences infringes two Cellectis patents relating to its proprietary meganuclease recombination systems. The Precision Biosciences' meganucleases at issue are intended to target site-specific DNA breaks and effect a desired genome modification in a given transgenic organism, such as a plant. The lawsuit seeks both monetary damages for infringement, as well as a permanent injunction preventing Precision BioSciences from any further making, using or selling of such meganucleases. "We take our intellectual property rights very seriously and intend to vigorously pursue this patent infringement case," said Dr. Andre Choulika, CEO and co-founder of Cellectis SA., and the man who participated in coining the term "meganuclease."

Since its creation in January 2000 and throughout its development, Cellectis has made special efforts to protect new discoveries made by its research team as well as those of its partner, the world-renowned Institut Pasteur. Cellectis currently owns the exclusive rights to over 35 issued patents and 113 pending patent applications. Most of these patents are based on Cellectis' fully integrated genome engineering system referred to as its Meganuclease Recombination Systems (MRSs). These systems offer natural, efficient, precise and flexible genome surgery with several applications, among others, in the therapeutic area and in the plant science field.

Panacea Biotec revokes Cyclosporin patent of Novartis AG in Europe

European Patent Office in Munich has given the decision in the favor of Panacea Biotec Ltd. by revoking Novartis European Patent number EP1059913 in its entirety.



Panacea Biotec had filed an ‘Opposition’ in 2005 against European patent bearing patent number EP1059913 assigned to Novartis AG, entitled “Emulsion preconcentrates containing cyclosporine or a macrolide”. ‘Opposition’ proceedings’ by Panacea Biotec were filed on the grounds of ‘Lack of Novelty’ and ‘Inventive-step’ against EP1059913 over the prior arts cited by the opponent. ‘Novartis’ filed its response for the Opposition. Later on; Novartis filed two auxiliary requests in order to protect their granted patent. In August 2007, summons for ‘Oral hearing’ were issued to both the parties, ‘Opponent herein referred to as Panacea Biotec’ and ‘Patentee herein referred to as Novartis AG’. Subsequently on Oral hearing the European Patent - EP patent 1059913 was revoked on account of being taken of the amendments made by the patent proprietor (Novartis) during opposition proceedings such that the patent and the invention to which it relates were found not to meet the requirements of the EPC (Art. 101(3) (b) EPC).



This victory stands as the testimony for Panacea Biotec to be an Innovation focused company. Further; this case serves as one of the major victories by an Indian pharmaceutical company in the lucrative European market.

Glenmark launches nabumetone & hydroxyzine tabs in US

Glenmark Pharmaceuticals Inc (GPI), the US subsidiary of Glenmark Pharmaceuticals Limited (Glenmark), has initiated the marketing and distribution of nabumetone tablets and hydroxyzine hydrochloride tablets in the US market.

Glenmark commenced shipping immediately upon final approval from the US Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for nabumetone tablets in 500mg and 750mg strengths and hydroxyzine hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc (InvaGen).

The company will exclusively market and distribute nabumetone and hydroxyzine hydrochloride tablets while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on nabumetone and hydroxyzine hydrochloride tablets' sale in the US will be shared equally between Glenmark and Invagen.

Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis. According to IMS Health data, for the 12 month period ending December 2007, the market size of nabumetone was USD 97 million.

Hydroxyzine belongs to a group of medicines called sedating antihistamines. Its main use is to help in the treatment of anxiety. According to IMS Health data, for the 12 month period ending December 2007, the market size of hydroxyzine hydrochloride was USD 60 million.

District Court Upholds Validity of P&G's Actonel Patent, Rejecting Teva's Obviousness Arguments

(As per the article published on Orange book blog)

Proctor & Gamble v. Teva Pharms. USA, No. 04-940 (D. Del. 2008)

Late last month, the U.S. District Court for the District of Delaware (J. Farnan) upheld the validity of Proctor & Gamble's U.S. Patent No. 5,583,122, which claims risedronate sodium, the active ingredient in Actonel. Teva had challenged the '122 patent in a paragraph IV certification in its ANDA. P&G's U.S. sales of Actonel, which is indicated for the prevention and treatment of osteoporosis, were approximately $1 billion last year.

Teva alleged that the '122 patent is invalid as obvious in light of U.S. Patent No. 4,761,406, entitled "Regimen for Treating Osteoporosis." Alternatively, Teva alleged that the '122 patent is invalid for obviousness-type double patenting in view of the '406 patent. Specifically, Teva argued that the structural similarities between risedronate, claimed in the '122 patent, and 2-pyr EHDP, disclosed and claimed in the '406 patent, render claims 4, 16 and 23 of the '122 patent obvious.

The district court's opinion relies heavily on the Federal Circuit's decision last year in Takeda v. Alphapharm:

The Federal Circuit has held that "structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness." Takeda. In addition to structural similarities, the Federal Circuit has also required a showing of "adequate support in the prior art" for the change in structure. Id. Clarifying these principals further, the Federal Circuit has held that a prima facie case of unpatentability requires a "showing that the prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention."

Reviewing the evidence adduced at trial in light of these legal principles, the Court concludes that Teva has not established by clear and convincing evidence that "the prior art would have suggested making the specific molecular modifications necessary" to achieve risedronate. To begin, the Court is unpersuaded that a person of ordinary skill in the art would have selected 2-pyr EHDP as the "lead compound" out of the numerous compounds disclosed in the '406 patent.

The court further concluded, "even if Teva can establish a prima facie case of obviousness, Proctor & Gamble has demonstrated sufficient evidence of unexpected results regarding resedronate's potency and toxicity to rebut such a prima facie showing." Finally, the court determined that Teva had not proven double patenting, as "the same type of analysis is used for an obviousness-type double patenting inquiry as for a Section 103 obviousness inquiry."

The '122 patent won't expire until December 2013. Teva immediately announced its intention to appeal the district court's decision to the Federal Circuit.

ProEthic Pharmaceuticals Announces Launch of Ibudone for Acute Pain

Mar 13, 2008 - ProEthic Pharmaceuticals, Inc. today announced the launch of Ibudone(TM) (hydrocodone bitartrate and ibuprofen tablets), a new prescription fixed combination of hydrocodone and ibuprofen for the short-term (generally less than 10 days) management of acute pain.

Ibudone provides the highest hydrocodone/ibuprofen dosage available - 10 mg of hydrocodone/ 200 mg of ibuprofen - in each tablet. Peak plasma levels are achieved in less than two hours. Ibudone is also available with 5 mg hydrocodone/ 200 mg of ibuprofen.

Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, "By combining 10 mg of hydrocodone with the gold standard NSAID, ibuprofen, Ibudone offers a powerful new option for relieving acute pain. It is important to note that Ibudone does not have the risk of acetaminophen liver toxicity, a leading cause of acute liver failure in the United States. In addition, Ibudone also offers physicians Schedule III prescribing convenience, a key issue with today's busy practices."

ProEthic acquired the exclusive marketing, sales and distribution rights to Ibudone from Vintage Pharmaceuticals (Huntsville, Alabama). To learn more about Ibudone, visit www.ibudone.com.

No Sign of ANDA Filing for Daptomycin

Mar 13, 2008 - Cubist Pharmaceuticals (NASDAQ: CBST) said today that it believes that no generic manufacturer acted last September to secure a potential "first to file" advantage, by filing an abbreviated new drug application (ANDA) for daptomycin. If such a filing had occurred, the generic company would have had to notify Cubist within 20 days of acceptance of the ANDA by the FDA. It is now a full six months since September 12, 2007--the first opportunity for a generic company to file an ANDA and the only date on which a generic company could be assured of securing the "first to file" advantages available under the Hatch-Waxman legislation--and Cubist has received no notification.

As of March 11, 2008, the FDA Office of Generic Drugs (OGD) web site had listed twenty-six accepted filings for ANDAs filed since September 12, 2007. The March 11, 2008 update to the OGD web site (http://www.fda.gov/cder/ogd/ppiv.htm) included seven ANDAs submitted between November, 2007 and mid-January, 2008.

The company believes it is significant that no generic company appears to have assured itself of the "first to file" advantage by filing on September 12, 2007. Cubist President and CEO, Mike Bonney, cited two key challenges that may have created hurdles for a generic manufacturer considering such a filing: "First of all, to file an ANDA, a generic company would have to believe they could successfully challenge the daptomycin patents listed in the FDA Orange Book." The Orange Book patents for CUBICIN(R) (daptomycin for injection) include two method-of-administration patents based on the discovery by Cubist scientists Drs. Tally and Oleson. This discovery made it possible to complete clinical trials for daptomycin as an I.V. antibiotic at doses high enough to treat serious skin and bloodstream infections caused by Gram-positive pathogens, including MRSA. "CUBICIN, which as of year-end 2007 had been used in the treatment of an estimated 460,000 patients, would not have become a drug without the discovery on which these patents are based," Bonney pointed out. "We stand behind these patents and are prepared to defend them vigorously if they are challenged."

The company also noted that only three of the twenty-six ANDA filings accepted by the FDA since September 12 have been for intravenously delivered products. "Making an I.V. drug is almost always more costly than making an oral therapy such as a pill," said Bonney. "In the case of daptomycin there are some unique challenges in the purification process that add to the cost of manufacture. This would impact margins if a generic manufacturer determined that it would need to price a 'generic CUBICIN' at or near the acquisition price of the existing generic I.V. therapy in this market, vancomycin."

Under the terms of the Hatch-Waxman legislation enacted in 1984, a generic manufacturer has the right to challenge the U.S. patent protection of a drug, by filing an ANDA with a paragraph IV certification, one year prior to the expiration of FDA-granted data exclusivity. For CUBICIN, that date was September 12, 2007. The Hatch-Waxman legislation provides an incentive to encourage such filings. A generic manufacturer who is the first to file an ANDA with a paragraph IV certification and who prevails in patent litigation is eligible for 180 days of exclusivity, during which the FDA will not authorize another generic drug for marketing in the U.S.

Further information about the intellectual property protection for CUBICIN, including information on the three FDA Orange Book listed patents, is available on the Investor Relations page at www.cubist.com

Hawthorn Pharmaceuticals, Inc. Receives FDA Approval on Granisol Oral Solution

Mar 13, 2008 - Hawthorn Pharmaceuticals, Inc. announced today the US Food and Drug Administration (FDA) approval of the company's Granisol(TM) (granisetron HCl) Oral Solution. Granisol(TM) is an oral solution for the prevention of nausea and vomiting associated with cancer therapy. Granisol(TM) is the AA-rated equivalent of Roche's Kytril(R) Oral Solution.

"According to the National Cancer Institute, oral mucositis occurs in almost all patients receiving radiation for head and neck malignancies, in more than 75% of bone marrow transplant recipients, and in nearly 40% of patients receiving chemotherapy," said Chris Smith, Vice President of Sales. "We feel this product will fill an important need in helping to prevent nausea and vomiting associated with chemotherapy or radiation for cancer therapy patients who may have difficulty swallowing tablets."

Granisol(TM) Oral Solution is available through all the national drug wholesalers as well as multiple other distribution channels and will begin shipping immediately. Granisol(TM) Oral Solution is available by prescription only in the United States.

Watson Files ANDA for Generic Lybrel

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth. Watson's Levonorgestrel and Ethinyl Estradiol product is a generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol) tablets which is indicated for the prevention of pregnancy.

Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 6,500,814. Wyeth's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

Sandoz sued by Sanofi to Protect Ambien Patent

Sanofi-Aventis filed a law suit on Friday against Sandoz, a subsidiary of Novartis AG, to keep Sandoz away from marketing its generic version of insomnia drug Ambien CR.

Sandoz recently filed an ANDA with the USFDA to market a generic extended-release pill containing zolpidem tartrate, the active ingredient in Ambien, before Sanofi's patent on the drug, U.S. Patent Number 6,514,531, expires, Sanofi says in a complaint filed in the U.S. District Court for the District of New Jersey.

The '531 patent, issued to Sanofi in 2003, describes a “controlled-release dosage forms of zolpidem or salts thereof adapted to release zolpidem over a predetermined time period.”

Sandoz claimed in its ANDA that the '531 patent is invalid, according to Sanofi's complaint.

“By filing the ANDA ... for the purpose of obtaining approval to engage in the commercial manufacture, use or sale of its proposed zolpidem tartrate extended release tablets before the expiration of the '531 patent, Sandoz has committed an act of infringement,” Sanofi said.

“Further, the commercial manufacture, use, offer for sale, sale and/or importation of tablets made under that ANDA will also infringe one or more claims of the '531 patent,” it said.

Sanofi has asked the court to enjoin Sandoz from selling a generic version of
Ambien until the '531 patent expires and to award monetary damages for any other
acts of infringement it might find.

Sanofi has also moved to protect the market for Ambien, which currently has no competitors, from generic competition by other companies.

Last June, the company sued Mutual Pharmaceutical Company Inc., United Research Laboratories Inc. and their parent company Pharmaceutical Holdings Corp., which had also filed an ANDA to make generic versions of Ambien. Those suits are still pending in the District of New Jersey.

In addition, Sanofi filed suit in February 2007 against Dutch pharmaceutical company Synthon Holding BV over an ANDA Synthon submitted in a bid for FDA approval to market generic Ambien in the U.S.

As in the suits against Sandoz and Mutual, Sanofi asserted the '531 patent in
its suit against Synthon.

Ambien, which was approved for sale in the United States in the early 1990s, is
one of Sanofi's biggest sellers, generating $1.9 billion in sales during the
first nine months of 2006.

Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA

March 12, 2008 – Luitpold Pharmaceuticals, Inc. reported today that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter for its new drug application (NDA) for Injectafer™ (ferric carboxymaltose injection) (Internal name VIT-45), an intravenous iron injection, for the treatment of iron deficiency anemia in women due to postpartum (PP) or heavy uterine bleeding (HUB).

Wyeth Europa Ltd Withdraws Its Marketing Authorisation Application for Pristiqs (desvenlafaxine)

March 12, 2008-The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its decision to withdraw the application for a centralised marketing authorisation for the medicine Pristiqs (desvenlafaxine) 50mg and 100mg prolonged release tablets.

Pristiqs was expected to be used for the treatment of vasomotor symptoms associated with menopause. The application for marketing authorisation for Pristiqs was submitted to the EMEA on 4 October 2006. At the time of the withdrawal, it was 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 Pristiqs was based on its plans to conduct additional clinical studies that would address the CHMP’s questions regarding the benefit-risk profile of Pristiqs as a treatment for vasomotor symptoms.

FDA approval of Abbott's Simcor marks start of co-promotion with Solvay

March 12, 2008-Solvay welcomes the recent U.S. Food and Drug Administration (FDA) approval to market SIMCOR® (Niaspan®/simvastatin), a fixed-dose combination lipid therapy developed by Abbott, in the United States, which has resulted in a milestone payment of USD 100 million from Solvay to Abbott. This marks the start of planned co-promotion efforts. Solvay Pharmaceuticals was granted co-promotion rights in the United States for SIMCOR® as a result of an agreement with Abbott announced on October 22, 2007.

Further to the USD 100 million capital investment, Solvay Pharmaceuticals will start contributing to the commercial expenses of SIMCOR® in the first quarter of 2008.“The treatment of cardiometabolic diseases is one of Solvay Pharmaceuticals’ strategic therapeutic areas,” said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc. “We are excited about the collaboration on SIMCOR®, which extends Solvay’s presence in the United States and builds on a long-standing partnership with Abbott on TriCor®. Further developments include SLV348/ABT 335, the next-generation fenofibrate, for which Abbott submitted a New Drug Application to the FDA in the 4th quarter of 2007.”SIMCOR® combines two well-established and leading medications, Niaspan and simvastatin, to target multiple lipid parameters - LDL "bad" cholesterol and HDL "good" cholesterol – in a single pill.

Loxonin Tape 50mg/100mg Receives Approval for Manufacture and Marketing

DAIICHI SANKYO COMPANY, LIMITED (President and representative director: Takashi Shoda) and Lead Chemical Co., Ltd. (President: Masao Mori) today announced that they received an approval for manufacture and marketing of the percutaneous absorption-type analgesic and anti-inflammatory preparation, Loxonin® Tape 50mg/100mg (generic name: loxoprofen sodium) by the Japanese Ministry of Health, Labour and Welfare on March 7, 2008. The product is jointly developed by both firms.

Loxonin® Tape is the first loxoprofen sodium adhesive tape in Japan containing the same constituents as Loxonin® pills and Loxonin® powder which are leading agents among orally administered analgesic and anti-inflammatory drugs. The adhesive tape is expected to have superior analgesic and anti-inflammatory efficacy when applied once per day.

Following the launch of Loxonin® Pap in 2006, we are confident that this new addition to the long-standing top brand Loxonin® will further contribute to analgesic and anti-inflammatory drug treatment.

This preparation is scheduled to be manufactured by Lead Chemical and sold by DAIICHI SANKYO.

Sandoz Enhances Patient Access with Launch of Omnitrope Pen 5 with Liquid Cartridge

March 12, 2008 -- Sandoz today announced the introduction in the United States of Omnitrope(TM) Pen 5 with liquid cartridge, a new form of the first follow-on version of a previously approved recombinant biotechnology drug approved by the Food and Drug Administration. Omnitrope, a somatropin (rDNA origin) for injection recombinant, is approved for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency. The Omnitrope Pen 5 with liquid cartridge approved by the FDA is available in 5 mg strength at a price of USD 33.65/mg, which is approximately 35% less than the published price for Genotropin®, the comparator reference product, and other leading recombinant growth hormones. This new delivery system is more convenient for patients because the liquid is already dissolved in a ready-to-use cartridge and can be loaded into the pen for injection.According to the FDA, Omnitrope is highly similar to Genotropin in its pharmacokinetic/pharmacodynamic, safety and efficacy profiles, which is a very high regulatory standard and the same comparability standard currently applied to brand products when they make manufacturing changes. "The Omnitrope Pen 5 with liquid cartridge represents Sandoz commitment to meeting the needs of patients through providing more convenient delivery systems," said Bernhard Hampl, chief executive officer of Sandoz Inc., the US subsidiary of Sandoz. "This launch is another milestone in our continuing efforts to provide US healthcare providers and patients with greater access to high-quality biologic medicines at more affordable prices." An Omnitrope liquid pen system has been available in Europe since spring 2007. A lyophilized powder form of Omnitrope was launched in the US by Sandoz in January 2007, following its approval by the FDA in May 2006 under the 505(b)(2) Pathway of the Hatch-Waxman Act. Shortly prior to that, Omnitrope was also the first biosimilar to be approved in Europe. No other follow-on biologic (referred to as biosimilars in Europe) has received approval and been made available to patients in both regions.Sandoz strongly supports a balanced position on follow-on biologics, which advocates that the same standards of high quality and science consistently be applied to all medicines, ensures respect for legitimate intellectual property, and recognizes the role that generic drugs and follow-on biologics can play in the health care system.

Connecticut AG Blumenthal Sues Eli Lilly For Illegally Marketing Antipsychotic Drug Zyprexa For Unapproved Uses

March 11, 2008 -Attorney General Richard Blumenthal today sued Eli Lilly and Company, Inc. for illegally marketing its antipsychotic drug Zyprexa for unapproved uses, and concealing the drug's serious side effects, for more than a decade.

Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children.

The deceptive marketing campaign dangerously concealed risks associated with Zyprexa, including diabetes, cardiovascular problems, and significant weight gain.
In a lawsuit filed today, Blumenthal seeks to recover millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa.
"The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems," Blumenthal said. "This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects.
"Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa.
"Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly's illegal, senseless schemes."
Blumenthal sued pursuant to the Connecticut Unfair Trade Practices Act (CUTPA) and the federal Racketeering Influenced and Corrupt Organizations Act (RICO) on behalf of Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr. and Department of Social Services (DSS) Commissioner Michael Starkowski.

Trial Date Set For Seroquel Patent Litigation

March 12, 2008-AstraZeneca today announced a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries Ltd. and Sandoz, Inc. alleging infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings of Abbreviated New Drug Applications (ANDAs). The ANDAs seek approval to market generic versions of SEROQUEL® (quetiapine fumarate tablets) in the US before SEROQUEL’s patent expires in 2011. The Court has set a date for trial beginning on 11 August 2008.

Strides Arcolab Receives Health Canada Approval for Tazo Pip Injection

12-Mar-08-Strides Arcolab today announced its second ANDS approval from Health Canada for Tazo Pip Sterile Injection in three presentations.

The product is licensed to an undisclosed partner in Canada and the company expects to launch the product immediately.

Pip Taz is amongst the various sterile submissions the company has submitted with Health Canada. Tazo Pip is a generic version of Tazocin ® – registered trade mark of Wyeth. Market for Pip Taz in Canada is approximately US$ 20 million and has global sales of over US$ 500 million

Barr Receives Approval for Generic Taxol Injection USP, 6mg/mL

March 12, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Bristol-Myers Squibb Company's Taxol(R) (paclitaxel) Injection USP, 6mg/mL, packaged in 100mg/16.7 mL and 300mg/50 mL Multiple-dose Vials. The Company plans to launch its product shortly. Barr's U.S. generic injectable portfolio now totals seven products.

Barr's product will compete in a market that had annual sales of approximately $98 million for the twelve months ended January 2008, based on IMS sales data.

US FDA extends review period for J&J's nosocomial infection drug

Johnson & Johnson Pharmaceutical Research and Development, L.L.C, said the US Food and Drug Administration (FDA) has extended the review timeline for the second New Drug Application for the antibiotic Doribax (doripenem for injection). The application, submitted in June 2007, seeks approval to market Doribax to treat nosocomial, or "hospital-acquired," pneumonia and ventilator-associated pneumonia, which occurs in patients who are on mechanical ventilation because they cannot breathe on their own.

The FDA extended the review period by three months to provide time for a full review of the application after receiving additional information it had requested from the company.

Doribax is already FDA-approved to treat complicated urinary tract and complicated intra-abdominal infections and is marketed by Ortho-McNeil , Division of Ortho-McNeil-Janssen Pharmaceutical Services, Inc., in the US. The use of Doribax to treat complicated urinary tract and complicated intra-abdominal infections and nosocomial pneumonia, including ventilator-associated pneumonia, currently is under regulatory review in Europe, Canada and in other countries. Doribax is licensed from Shionogi and Co., Ltd.

Doribax is indicated as a single agent for the treatment of: complicated intra-abdominal infections caused by susceptible strains of E. coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S. constellatus or P. micros, and for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible strains of E. coli, including cases with concurrent bacteremia, K pneumoniae, P. mirabilis, P. aeruginosa, or A baumannii.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doribax and other antibacterial drugs, Doribax should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dabur gets approval for generic version of Camptosar in Italy & Denmark

Dabur Pharma Ltd has received approvals for irinotecan hydrochloride injection, generic version of Pfizer's Camptosar, in Italy and Denmark. The company had successfully launched the generic version of the drug in the US recently. It has also received approval for the drug in the UK.Ajay Kumar Vij, chief executive officer, Dabur Pharma Ltd., said, "We are extremely pleased to receive these approvals for irinotecan across Europe. This bear testimony to the strong foundation we are laying towards becoming one of the leading oncology players across the globe."Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. It is also indicated for patients with metastatic carcinoma of the colon or rectum where disease has recurred or progressed following initial fluorouracil based therapy.

Gilead seeks EU marketing nod for nebuliser solution

Gilead Sciences, Inc. has submitted a Marketing Authorisation Application (MAA) for approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA).

Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalised, provides one marketing authorization in all member states of the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow Nebuliser (PARI GmbH).

The MAA is supported by data from two phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2.

"Chronic pseudomonal airway infection represents the single greatest cause of morbidity and mortality for people with cystic fibrosis, and with a limited number of inhaled antibiotics, there remains a significant unmet medical need," said A. Bruce Montgomery, MD, senior vice president and Head, Respiratory Therapeutics, Gilead Sciences. "The submission of this MAA in the European Union further underscores Gilead's commitment to advancing therapies for patients with this life-threatening disease."

Aztreonam lysine 75 mg powder for nebuliser solution is an investigational therapy and has not yet been determined safe or efficacious in humans. Aztreonam lysine 75 mg powder for nebuliser solution is an antibiotic candidate currently being studied in an ongoing phase III open label trial for people with cystic fibrosis who have pulmonary P. aeruginosa. Aztreonam has potent activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is a US Food and Drug Administration (FDA)-approved agent for intravenous administration. Aztreonam lysine is a proprietary formulation of aztreonam developed specifically for inhalation and has been designated with orphan drug status in the United States and Europe. In the United States, the investigational product is referred to as aztreonam lysine for inhalation. Gilead submitted its US New Drug Application for aztreonam lysine for inhalation to the FDA on November 16, 2007. The FDA has established a target review date, under the Prescription Drug User Fee Act, of September 16, 2008. Gilead submitted its application in Australia on November 30, 2007.

Aztreonam lysine 75 mg powder for nebuliser solution is delivered by an eFlow Nebuliser, developed by PARI Pharma GmbH. eFlow is a portable nebuliser that enables aerosolisation of liquid medications via a vibrating, perforated membrane. PARI Pharma also contributed to the development and optimization of the drug formulation (aztreonam lysine 75 mg powder for nebuliser solution) for delivery via eFlow. Based on PARI's 100-year history working with aerosols, PARI Pharma is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.

Schering-Plough Announces Filing of U.S. Application for OTC Zegerid

Schering-Plough Corporation today announced a submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for ZEGERID(R) (omeprazole/sodium bicarbonate) in the dosage strength of 20 mg of omeprazole as a branded over-the-counter (OTC) product to treat frequent heartburn.

The NDA was submitted under the terms of a license agreement with Santarus, Inc. of San Diego, Calif., which was signed in October 2006 for the exclusive U.S./Canadian rights to market OTC ZEGERID proton pump inhibitor (PPI) products using Santarus' patented technology.
"Schering-Plough is looking forward to working with the FDA to bring this prescription product to consumers as an OTC treatment for frequent heartburn," said John E. O'Mullane, B.Sc., Ph.D., group vice president, Research and Development, Schering-Plough Consumer Health Care. "When approved, ZEGERID will be a valuable addition to our expanding portfolio of gastrointestinal OTC products such as MiraLAX(R), which was launched last year for the treatment of occasional constipation."

Under the agreement with Santarus, Schering-Plough is responsible for the development, manufacturing and commercialization of ZEGERID (omeprazole/sodium bicarbonate) OTC products for heartburn-related indications in the U.S. and Canada. Santarus continues to manufacture, promote and sell its ZEGERID (omeprazole/sodium bicarbonate) prescription products in both 20 mg and 40 mg dosage strengths of omeprazole for the U.S. prescription market for PPI products.

FDA Approves New Drug Application for LEVOleucovorin, Spectrum's First Proprietary Oncology Drug

Mar 7, 2008 -Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.

LEVOleucovorin was reviewed under a full NDA, and included an Oncologic Drug Advisory Committee (ODAC) review. Spectrum anticipates that the drug will be listed without any therapeutically equivalent product in the FDA Orange Book. Drugs without therapeutic equivalents are considered 'single source drugs' which under section 1847A of the Social Security Act generally qualify for a separate reimbursement code with CMS.

U.S. Patent Office Upholds Two Additional Human Embryonic Stem Cell Patents in Reexamination Decisions

Mar 11, 2008 - Geron Corporation (Nasdaq:GERN) announced today that the U.S. Patent Office has upheld the validity of two additional patents for human embryonic stem cells (hESCs) that were challenged through reexamination proceedings.

In its latest communication, the Patent Office issued Notices of Intent to Issue Ex Parte Reexamination Certificates for U.S. Patent Numbers 5,843,780 and 6,200,806, which claim preparations of, respectively, primate and human embryonic stem cells and methods for their isolation. During the proceedings, the Wisconsin Alumni Research Foundation (WARF), an organization to which the patents are assigned, made minor amendments to certain claims to improve clarity and consistency and added three new claims to each patent. The decisions of the Patent Office on these two patents are final and cannot be appealed.

Last month, the Patent Office upheld the claims of a related third patent: U.S. Patent Number 7,029,913. All three patents are assigned to WARF and licensed exclusively to Geron for the development and commercialization of therapies based on three types of cells derived from hESCs: neural cells, cardiomyocytes and pancreatic islet cells. Geron is also licensed non-exclusively for the development and commercialization of other cell types derived from hESCs for therapeutic and non-therapeutic uses.

"We are pleased that the Patent Office has reconfirmed the validity of all three of the patents," said David J. Earp, J.D., Ph.D., Geron's chief patent counsel and senior vice president of business development. "The reexamination proceedings were detailed and comprehensive, and the positive outcomes have strengthened the patents."

Nastech Pharmaceutical Company Inc. Completes Key RNAi Patent Filings

Mar 11, 2008 - Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today that it has completed filing 83 patent applications (79 international applications and 4 U.S. applications) directed toward 144 different genes with siRNA's designed and modified using Nastech's proprietary RNAi technologies. These gene targets are disease-validated against cancer, inflammatory disease, and metabolic disorders. Overall, these patent applications are directed toward tens of thousands of targets.

The inventions involve the use of Dicer substrates (25-30 nucleotide two-stranded duplexes), Meroduplex substrates (three stranded constructs with an antisense strand of 15-30 nucleotides and two sense strands), and non-chemically modified base substitutions with specific, experimentally determined sequences within the 144 gene sequences, which include the disease-validated targets. The inventors of this target gene patent estate, Drs. Steven Quay, James McSwiggen, Narendra Vaish, and Mohammad Ahmadian, are all Nastech employees.

"Today's announcement is the culmination of our multi-year intellectual property strategy in RNAi," stated Steven C. Quay, M.D., Ph.D., Nastech's Chairman and CEO. "Our goal has been to provide a patent estate for potential partners that is independent of the two primary, exclusively licensed commercial IP estates, one such estate directed broadly to RISC substrates without reference to target genes and the other such estate directed to a set of target genes that operate with either Dicer or RISC. Until now, these two estates effectively tied up the most interesting and commercially promising targets for just two companies to exploit. For the first time in several years, all 20,000 human genes are once again available for development through our patent estate enabling us to pursue any disease target of our choosing without the need to obtain licenses to existing patents."

Sigma-Aldrich, Oxford BioMedica and Open Biosystems Settle Patent Dispute Over Use of LentiVector Technology in Research Reagents

Sigma-Aldrich , Oxford BioMedica and Open Biosystems, Inc., a privately held corporation, have jointly announced a confidential settlement of their patent litigation. Sigma-Aldrich and Oxford BioMedica agreed to dismiss the lawsuit brought against Open Biosystems. Open Biosystems agreed to dismiss its counterclaims in the lawsuit. As part of the settlement Open Biosystems will acquire certain license rights under the Oxford BioMedica patents for use of the LentiVector technology in research activities. Other details of the agreement have not been disclosed

Akorn-Strides, LLC Announces FDA Approval for Tobramycin Injection USP, 80 mg/2mL and 1.2 grams/30mL

Mar 11, 2008 - Akorn-Strides, LLC today announced the approval of an ANDA for Tobramycin Injection USP, 80 mg/2mL and 1.2 grams/30mL. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR, BSE: 532531). The primary mission for the Joint Venture is developing liquid, lyophilized and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.

Tobramycin Injection is an antibiotic and is indicated for the use in treating or preventing infections that are proven or strongly suspected to be caused by susceptible bacteria. Recent IMS data estimates an annual marketsize of approximately $19 million.

The current product portfolio of the Joint Venture, which is funded equally by Akorn and Strides Arcolab, was recently expanded and now includes 29 ANDA's with a total of 53 SKU's, or product line offerings. To date, the Joint Venture has filed for 17 ANDA's. The Joint Venture expects to generate product revenues in 2008 based on this and future product approvals, as well as subsequent product launches.

In a statement given by Arthur S. Przybyl, President and CEO of Akorn and Member Manager of Akorn-Strides, LLC, "We are excited to announce this product approval for Tobramycin Injection."

Perrigo Company Receives Final Approval on Clobetasol Propionate Foam

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.

The product is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008. As the first filer, Perrigo will be eligible for 180 days of generic marketing exclusivity once it launches the product.

Perrigo's Chairman and CEO Joseph C. Papa stated, "We are obviously excited about this approval. This approval reflects our on-going efforts to make quality healthcare more affordable for our customers and drive value for our shareholders."

In late 2005, Connetics Corporation, which sells the brand drug, filed a patent infringement suit against Perrigo in the United States District Court for the District of New Jersey following Perrigo's paragraph IV patent certification in its ANDA stating that the Connetics' patent is invalid, unenforceable, or will not be infringed by Perrigo's ANDA. In response to a motion filed by Connetics last Thursday, the Court temporarily restrained Perrigo, as of March 7, 2008, from manufacturing, using, offering to sell, selling or importing into the United States its product pending the outcome of a hearing on March 19, 2008. On that date, the Court will hear arguments on Perrigo's pending Summary Judgment Motion as well as Connetics' Motion for a Preliminary Injunction.

Teva Sues FDA After the Agency Refuses to Relist RISPERDAL Patent and Recognize the Company’s 180-Day Exclusivity Eligibility

As previously published, In August 2007, Teva Pharmaceuticals USA submitted a citizen petition to FDA requesting that the Agency relist in the Orange Book U.S. Patent #5,158,952 (“the ‘952 patent”) covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets (approved under NDA #20-272), and to confirm the company’s eligibility for 180-day exclusivity. (See Orange Book Blog post here.) According to the petition, Teva submitted ANDA #76-228 to FDA on August 28, 2001. The ANDA contained a Paragraph III certification to U.S. Patent #4,804,663 (which expired in December 2007, but is covered by a period of pediatric exclusivity scheduled to expire in June 2008), and a Paragraph IV certification to the ‘952 patent. In October 2001, FDA notified Teva that the ‘952 had been delisted from the Orange Book, and required the company to amend its patent certification to reflect that the ‘952 patent was no longer listed in the Orange Book as claiming RISPERDAL Tablets. Teva complied and submitted the ANDA amendment. In November 2006, the U.S. Court of Appeals for the District of Columbia decided in Ranbaxy Laboratories Ltd. v. Leavitt that FDA may not delist a patent from the Orange Book following the submission of an ANDA with a Paragraph IV certification to that patent. Teva states in its petition that following the Ranbaxy decision the company reviewed its ANDA portfolio for any potential unlawful patent delistings that could affect the company’s eligibility for 180-day exclusivity. This review led to the company’s August 2007 citizen petition.Teva argues in its petition that because the “official Orange Book” (that is, the printed edition of the Orange Book) listed the ‘952 patent when the company submitted ANDA #76-228, “FDA’s putative delisting of the ‘952 patent did not become effective until January 2002, when the official Orange Book reflected the delisting of that patent.” As such, according to Teva, given the decision in Ranbaxy, FDA could not have lawfully delisted the ‘952 patent because of the company’s Paragraph IV certification to that patent, and the company remains eligible for 180-day exclusivity. Teva also contends that because FDA “failed to provide official notice of the ‘delisting’ for several months following the submission of Teva’s ANDA,” the delisting does not affect Teva’s “entitlement” to 180-day exclusivity.

On February 26, 2008, FDA denied Teva’s petition. FDA states that according to the Agency’s records, the ‘952 patent was delisted before Teva submitted ANDA #76-228 to FDA, and that as a result, the delisting was proper and Teva is not eligible for 180-day exclusivity. Specifically, according to FDA, Janssen requested that the Agency delist the ‘952 patent from the Orange Book in April 2001, and “[i]n accordance with these instructions, FDA modified its patent listing database on June 11, 2001” to remove the patent from its RISPERDAL Orange Book file. FDA states that the “delisting of the ‘952 patent was reflected in the publicly available, electronic Orange Book shortly after June 29, 2001, and no later than July 20, 2001, the date of the next database update.” As such, “at the time Teva submitted its ANDA, the electronic Orange Book contained the most current information regarding patents listed for Risperdal tablets . . . [and Teva’s] assertion that the delisting of the ‘952 patent did not become effective until publication of the 2002 annual edition of the Orange Book is without merit.”

FDA notes that the Agency’s decision is consistent with the Ranbaxy decision. In Ranbaxy, “[t]he NDA holder’s request to delist the patents for simvastatin came almost 2 years after the Ranbaxy ANDA was submitted and almost 3 years after the Ivax ANDA was submitted. In contrast, [Janssen] requested that the ‘952 patent for Risperdal be delisted 2 to 4 months before Teva’s ANDA for risperidone was submitted” (emphasis in original).

Dissatisfied with FDA’s petition response, Teva sued the Agency on March 4, 2008 in the U.S. District Court for the District of Columbia requesting injunctive relief. Specifically, Teva’s complaint requests that the court enter an injunction compelling FDA to relist the ‘952 patent and restore the company’s paragraph IV patent certification, and declare that Teva is entitled to 180-day exclusivity. Teva also requests that the court enjoin FDA from granting final approval to other ANDAs for generic RISPERDAL during Teva’s 180-day exclusivity period. (Both Mylan and Pliva have tentatively approved ANDAs.) Teva’s memorandum accompanying the company’s motion for expedited preliminary injunctive relief makes similar requests and argues that “FDA’s refusal to relist the ‘952 patent and honor Teva’s right to 180-day exclusivity as the first Paragraph IV filer fundamentally undermines the Hatch-Waxman regime and flatly contradicts the [Ranbaxy decision].”

(As per the Article published on FDA Law Blog)

USV wins US rights to novel drug salt donepezil oxalate

Mumbai-based drug maker USV Ltd. scored a decisive win in a recent legal appeal, winning exclusive US rights to a new drug salt.

The new drug salt, donepezil oxalate, is effective in treating Alzheimer's disease. USV applied to patent this compound in 2004. USV's patent application described its invention as a "Composition of matter," the legal term used in the US patent statute. Surprisingly, the US Patent Office then refused to issue USV's patent application, arguing that the phrase "composition of matter," which appears in the patent statute itself, is too vague to support proper patent rights.

An appeals board in Washington disagreed. Rather, The Board of Patent Appeals and Interferences noted that a 1980 Supreme Court ruling involving another Indian inventor, Sidney A. Diamond v. Ananda Mohan Chakrabarty, concluded that the phrase "composition of matter" is perfectly acceptable. The appeals board thus concluded, in Ex parte Venkatasubraminarian Radhakrishnan Tarur et al., Appeal No. 2007-4478, that USV is entitled to its patent.

Mark Pohl, patent attorney with Pharmaceutical Patent Attorneys LLC of Morristown, New Jersey, argued on behalf of USV Limited; Celia C. Chang of Arlington, Virginia argued on behalf of the United States Patent Office. Talking about the new patent on donepezil oxalate, USV Ltd's managing director Prashant Tewari said, "The patent on our novel drug salt donepezil oxalate is very important for us. That is why when US patent office rejected our case we went for the appeal".

The company's R&D head Radhakrishnan said that donepezil oxalate is a novel salt for making the donepezil hydrochloride which is the final API product. It is very essential for us for meeting the international quality in our products. "There were several questions from the US Patent office regarding the product. We explained them all their doubts that is why we have received the patent now", Radhakrishnan said.

Gilead Submits MAA for Aztreonam Lysine 75 mg Powder for Nebuliser, for cystic fibrosis to EMA

Mar 7, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a Marketing Authorisation Application (MAA) for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA). Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow(R) Nebuliser (PARI GmbH).

The MAA is supported by data from two Phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2.

Rapinyl Has Received Swedish Marketing Authorization

7th March 2008 - Orexo's licensing partner for Rapinyl in Europe, ProStrakan Group plc announces that Rapinyl™ has received Swedish Marketing Authorization. It is anticipated that the product branded as "Abstral" will be launched in Sweden in Q3 2008 through Orexo's joint venture with ProStrakan, which operates in the Nordic countries.

Rapinyl™ is a fast-dissolving tablet for sublingual administration of fentanyl intended for the treatment of breakthrough cancer pain, for which ProStrakan Group plc, the international specialty pharmaceutical company, has in-licensed exclusive rights in Europe from Orexo. ProStrakan today announces that it has received Marketing Authorization in Sweden for Rapinyl™.

Pfizer Wins Challenge to Two Main U.S. Patents for Celebrex by Generic Manufacturer Teva

(Read the whole case as http://www.cafc.uscourts.gov/opinions/07-1271.pdf)

Mar 7, 2008 - Pfizer Inc announced today that the Court of Appeals for the Federal Circuit has upheld the two main U.S. patents covering Celebrex, the company's selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. The patents had been challenged by generic manufacturer Teva Pharmaceuticals USA.
The panel ruled that the patents (Nos. 5,466,823 and 5,563,165) covering the active ingredient and a pharmaceutical composition thereof are valid, enforceable and infringed by the generic manufacturer's product. In the same decision, the Court ruled that a third patent (No. 5,760,068) covering the use in the treatment of inflammation was invalid. The decision prohibits Teva from launching a competitor drug in the U.S. until May 2014. Either party may request a rehearing by the Court of Appeals or a review by the U.S. Supreme Court. Celebrex was approved by the FDA in 1998. Its sales totaled $1.7 billion the U.S. in 2007

Pfizer Wins Challenge to Two Main U.S. Patents for celecoxib (celebrex) by Generic Manufacturer Teva

(Read the whole case as http://www.cafc.uscourts.gov/opinions/07-1271.pdf)

Mar 7, 2008 - Pfizer Inc announced today that the Court of Appeals for the Federal Circuit has upheld the two main U.S. patents covering Celebrex, the company's selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. The patents had been challenged by generic manufacturer Teva Pharmaceuticals USA.

The panel ruled that the patents (Nos. 5,466,823 and 5,563,165) covering the active ingredient and a pharmaceutical composition thereof are valid, enforceable and infringed by the generic manufacturer's product. In the same decision, the Court ruled that a third patent (No. 5,760,068) covering the use in the treatment of inflammation was invalid. The decision prohibits Teva from launching a competitor drug in the U.S. until May 2014. Either party may request a rehearing by the Court of Appeals or a review by the U.S. Supreme Court. Celebrex was approved by the FDA in 1998. Its sales totaled $1.7 billion the U.S. in 2007

Court denied summary judgement to Dr. Reddys against Teva's Coreg patent

A district judge has allowed Teva Pharmaceutical Industries Ltd. to proceed with its lawsuit to bar Dr. Reddy's Laboratories Inc. from marketing a generic version of GlaxoSmithKline Inc.'s congestive heart failure drug Coreg.

Dr. Reddy's had asked the U.S. District Court for the District of New Jersey in October for a partial summary judgment that the first two claims of one of the patents at issue, known as the '008 patent, were invalid because they were anticipated by prior art.

Teva, an Israel-based generic drug company, responded that it was not even asserting the first claim, making the motion moot, and disputed the plaintiff's interpretation of the second claim.
In his opinion handed down on Tuesday, Judge Garrett E. Brown, Jr. sided with Teva.

“The court will deny DRL’s summary judgment motion to the extent it concerns claim 1 of the ‘008 patent because there is no case or controversy as to that claim,” the judge wrote. As for the second claim, he said, summary judgment would be “premature” until the court could decide in claim construction whether the plaintiff's reading was correct.

An attorney for Dr. Reddy's declined to comment on the ruling.

Hyderabad, India-based Dr. Reddy's Taro is one of more than a dozen pharmaceutical companies being sued by Teva over their plans to market copycat versions of GlaxoSmithKline's drug Coreg.

The lawsuits concern U.S. Patent Numbers 6,699,997; 6,710,184; 7,056,942 and 7,126,008 – all of which are owned by Teva. The patents cover carvedilol, the active ingredient in Coreg.

GSK was granted six months of pediatric exclusivity for Coreg after its patent for the drug expired on March 5, 2007. But Teva says in its lawsuits that the generic companies' plans to manufacture and sell Coreg's active pharmaceutical ingredient to third parties constitute an imminent threat of infringement.

The U.S. Food and Drug Administration approved 14 Abbreviated New Drug Applications for carvedilol in September – including Dr. Reddy's – after Glaxo's exclusivity period ended. Taro's ANDA sought to market generic versions of Coreg in four different dosages.

Many of the suits accuse the generic drug makers of not providing Teva information to determine whether the generic tablets would fall under the patent claims.

The importation, manufacture and sale of carvedilol will infringe one or more claims of the four Teva patents, or contribute to or induce such infringement, Teva claims in its complaints.
Teva has asked the court to declare that its patents are valid and enforceable and enjoin the generic manufacturers from infringing the four patents.

Coreg is a beta blocker used to treat high blood pressure. From late 2006 to late 2007, Glaxo's total sales of the drug (Coreg and Coreg CR) exceeded $1 billion.

Dr. Reddy's is represented in the case by Budd Larner PC. Teva is represented by Lite DePalma Greenberg & Rivas LLC.

The case is Teva Pharmaceutical Industries Ltd. et al. v. Dr. Reddy's Laboratories Ltd., case number 3:07-cv-02894, in the U.S. District Court for the District of New Jersey.

USV gets US patent on new way to make ropinirole

The Mumbai-based USV Ltd. has obtained US patent to a new way to make ropinirole, an active ingredient in GlaxoSmithKline's Parkinson's disease drug Requip.Requip has US sales of over US $500 million per year. GlaxoSmithKline's patents expire this spring, opening the market to a host of new, lower-cost generic products.To prepare for this, a team of researchers at Mumbai-based USV Limited developed a way to make ropinirole with a higher purity, and at a lower cost, than had previously been known. The US Patent Office has just ruled that USV is entitled to exclusive US rights to this invention. The US Patent Office decided that USV's patent application, Serial No. 10/888,901, is also entitled to a full scope of expanded coverage under a US legal doctrine known as the Doctrine of Equivalents. This is significant because such expanded coverage is currently accorded to only a small fraction of US patents, said a press statement from Pharmaceutical Patent Attorneys, LLC.

Biofrontera Expands the Patent Protection for Its Compound BF-1 in Migraine Prophylaxis

March 6, 2008 - Biofrontera AG (DSF: B8F) today announces that the Russian and Chinese patent offices have issued a patent for the migraine-prophylaxis compound BF-1. The patents protect the use of this substance as a pharmaceutical product in these countries. Biofrontera is currently developing this compound for the use in migraine prophylaxis. The two patents granted now expand the scope of protection for BF-1, which already entailed the whole of Europe, South Africa, and the USA. The issue of the patent in Hong Kong is awaited in the near future. Patents for Australia, Japan, Canada, Korea and India are pending.

Wyeth To Appeal Arkansas Hormone Therapy Trial Verdicts

Wyeth confirmed today that it will appeal the verdicts in the case of Donna Scroggin v. Wyeth, in the U.S. District Court, Eastern District of Arkansas, beginning with post-trial motions.

"There is no basis in fact or law for this award or for the earlier compensatory damage award. We will pursue several post-trial motions and will ultimately appeal the entire case if necessary. We are confident in our position on appeal," says Lyn P. Pruitt, an attorney with Mitchell, Williams, Selig, Gates & Woodyard, PLLC, a firm representing Wyeth in the case.
On February 25, 2008, the jury awarded the plaintiff $2.75 million in compensatory damages against Wyeth and co-defendant Upjohn. After a second phase of the trial, the jury subsequently awarded $19,360,000 in punitive damages against Wyeth and $7,760,000 against Upjohn.
Of the six other cases that have gone to trial and reached resolution, four resulted in judgments for Wyeth, one resulted in a plaintiff's judgment, while the other was remanded for a new trial. Four other cases set for trial were dismissed by courts on summary judgment and a dozen other trial-set cases have been voluntarily dismissed by the plaintiffs before trial.
The first phase of the trial began on February 5, 2008 before The Honorable William R. Wilson. The second phase began on March 3, 2008. The plaintiff alleged that she developed breast cancer from the use of Premarin(R) and Prempro(R), products marketed by Wyeth.
Premarin (conjugated estrogens tablets USP) and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) are approved by the U.S. Food and Drug Administration as safe and effective when used as indicated.

Perrigo Company to Market Over-the-Counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets

Perrigo Company today announced that its partner, Teva Pharmaceutical Industries Ltd. , has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.

The product will be marketed by Perrigo under store brand labels and is comparable to McNeil Consumer Healthcare's recently launched Zyrtec-D(R) Extended-Release Tablets, indicated for 12 hour relief of indoor and outdoor allergy symptoms and nasal congestion. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending December 2007 were approximately $190 million.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval and marketing agreement reflect our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders."
The Company expects to begin shipping the product in the next 90 days.

IMPAX Comments on Lawsuit Related to Generic Version of Detrol LA

Mar 6, 2008 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that Pfizer Inc., Pharmacia & Upjohn Co. LLC, and Pfizer Health AB (collectively "Pfizer") have filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Detrol LA(R) 2mg and 4mg capsules. IMPAX's ANDA submission includes a Paragraph IV certification stating the Company believes its product does not infringe Pfizer's listed patents or that the listed patents are invalid or unenforceable.

Pfizer markets Detrol LA for the treatment of overactive bladder and urinary incontinence. According to Wolters Kluwer Health, U.S. sales of Detrol LA capsules were approximately $857 million in the 12 months ended January 31, 2008.

"This suit is just a delaying tactic to prevent patients from accessing generic drugs sooner," commented Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "We believe that it is without merit and we will vigorously defend our ANDA."

Pfizer to acquire Serenex

Pfizer Inc said it has entered into an agreement to acquire Serenex, Inc., a privately-held biotechnology company with a phase I clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), an exciting target in the fight against cancer. Financial terms of the deal were not disclosed.

As per the agreement, Pfizer will acquire the rights to SNX-5422, an oral Hsp90 inhibitor currently in phase I trials for the potential treatment of solid tumours and haematological malignancies. Pfizer will also acquire Serenex's proprietary drug discovery technology and extensive small molecule Hsp90 inhibitor compound library. Compounds from this library have potential uses in treating deadly and debilitating diseases, such as cancer, inflammatory and neurodegenerative diseases. SNX-1012, another compound in clinical development for the treatment of oral mucositis in cancer patients, is not included in the agreement.

The transaction is expected to close in the second quarter of 2008, subject to customary closing conditions, including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

"The agreement to acquire Serenex is the latest step in the execution of Pfizer's strategy to expand our commitment to oncology, an area where Pfizer plans to establish a leadership position," said Jeffrey Kindler, chairman and chief executive officer, Pfizer.

"Pfizer is committed to pursuing compelling science taking place outside our laboratories, and the agreement to acquire Serenex is a splendid example of those efforts," said Martin Mackay, Ph.D., president, Pfizer Global Research and Development. "The Serenex oncology candidate extends Pfizer's substantial internal research efforts to develop novel treatments for cancer, a leading cause of death in the United States and much of the world. The library of early phase compounds also has wide potential for utility in a range of neurodegenerative and anti-inflammatory disorders, such as Alzheimer's disease, Parkinson's disease and arthritis".

Serenex discovered its small molecule Hsp90 inhibitors using a proprietary high-content screening platform that enabled the company to rapidly and simultaneously optimize libraries of compounds against a multitude of important therapeutic and toxicity targets. This novel technology improved the overall efficiency across the entire spectrum of drug discovery by dramatically improving library screening, mechanism of action determination and toxicity testing, lead optimization and candidate selection. Hsp90 is an important molecular chaperone protein that regulates the folding and degradation of client proteins involved in cell growth and survival. These signalling proteins play key roles in cancer, inflammatory diseases, and neurodegenerative diseases such as Alzheimer's. The potential of this exciting drug class in many other therapeutic indications is yet to be fully explored.

"We are pleased that our proprietary screening platform and product pipeline will become part of the superb scientific environment at Pfizer," said Richard Kent, M.D., president and chief executive officer, Serenex, Inc. "We are confident that Pfizer has the vision and resources necessary to leverage these new assets in its continuing efforts to produce much-needed new medicines".

NexMed Confirms Acceptance of NDS in Canada

Mar 5, 2008 - NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on its proprietary NexACT drug delivery technology, today announced that Health Canada has accepted the New Drug Submission (NDS) for its topical erectile dysfunction (ED) treatment for review. Health Canada's target is to complete review within three hundred (300) days for ninety percent (90%) of submissions.

Commenting on today's news, Vivian Liu, President and Chief Executive Officer of NexMed, stated, "We are very pleased to reach another regulatory milestone. The acceptance of the NDS for review is a positive development for the discussions with potential commercialization partners in Canada."

New 300mg Loading Dose Tablet for Plavix Receives Positive Opinion From the European Committee for Medicinal Products (CHMP)

March 05, 2008 /PRNewswire-FirstCall/ --Sanofi-aventis and Bristol-Myers Squibb Company announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix(R) (clopidogrel bisulfate). This positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval.

The new 300mg tablet will facilitate the use of the approved loading dose of Plavix(R) and the early initiation as recommended by national and international guidelines in appropriate patients with acute coronary syndrome (ACS), including those with unstable angina / non-ST segment elevation myocardial infarction (managed with percutaneous intervention (PCI) with or without stent or medically managed) and ST segment elevation myocardial infarction patients. The 300mg tablet is bioequivalent to four 75mg tablets of Plavix(R).

Sanofi-aventis and Bristol-Myers Squibb are committed to further studying the optimization of the Plavix(R) loading dose in ACS patients managed with an early invasive strategy in the ongoing large international clinical trial known as 'CURRENT'. CURRENT is the only randomized controlled trial designed to investigate in 14000 patients, whether the use of a clopidogrel 600mg loading dose, followed by an intensified clopidogrel dosing regimen (6 days at 150mg follow by 75mg) yields improved clinical outcomes as compared to clopidogrel 300mg loading dose followed by 75mg in ACS patients managed with an early invasive strategy. The primary endpoint of CURRENT is the reduction of a composite endpoint of cardiovascular death, stroke and myocardial infarct (MI) and the results are expected by the end of 2008.

EU Commission Approves Updated Prescribing Information for Aranesp

Mar 5, 2008 - Amgen (NASDAQ: AMGN) today announced that the European Commission reached its final decision to amend the prescribing information for Aranesp(R) (darbepoetin alfa) based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) in January 2008. The CHMP granted positive opinions for all centrally-authorized Erythropoiesis Stimulating Agents (ESAs) in the European Union (EU), each of which will receive European Commission Decisions. The European Commission's decision announced today is consistent with that described in Amgen's press release on Sept. 28, 2007 and the European Medicines Agency's (EMEA) announcement on Oct. 23, 2007.

A summary of key changes to the prescribing information for Aranesp are presented below. The CHMP has sought to ensure this information is consistently addressed in the Summary of Product Characteristics (SmPCs) for all ESA products in Europe.

-- Amending the SmPCs to stipulate a uniform target hemoglobin range of 10 g/dL to 12 g/dL with guidance to avoid sustained hemoglobin levels above 12 g/dL.
-- Providing guidance for dosage adjustments to maintain hemoglobin concentration between 10-12 g/dL once the therapeutic objective for an individual patient has been achieved. Patients should be monitored to ensure the lowest approved dose is used to maintain hemoglobin at a level that controls the symptoms of anemia.
-- Amending the Posology and method of administration section to recommend that Aranesp should be administered to cancer patients with symptomatic chemotherapy induced anemia (CIA) (e.g. hemoglobin concentration equal to or less than 10 g/dL (6.2 mmol/l)).
-- Amending the therapeutic indication for chronic renal failure (CRF) from "treatment of anemia associated with CRF" to "treatment of symptomatic anemia associated with CRF" in adult and pediatric patients.
-- Amending the Special Warnings to indicate ESAs have not been shown to improve overall survival or decrease the risk of tumor progression in patients with anemia associated with cancer. ESA trials have shown an unexplained excess mortality in association with high target hemoglobin concentrations (greater than 12 g/dL), including (1) shortened time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; (2) shortened overall survival in patients with metastatic breast cancer receiving chemotherapy; (3) increased risk of death when administered to target a hemoglobin of 12g/dL (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. Clinical trials in patients with CKD have also observed an increased risk of death and serious cardiovascular events when ESAs were administered to target a hemoglobin of greater than 12g/dL (7.5 mmol/l).

Barr Subsidiary Sues Watson for Seasonique Patent Infringement

Barr Pharmaceuticals, Inc. today announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., has filed suit against Watson Pharmaceuticals and its subsidiary, Watson Laboratories, Inc., for infringement of the patent protecting Duramed's Seasonique extended-cycle oral contraceptive product. The Company's SEASONIQUE Patent No. 7,320,969 is due to expire on January 30, 2024. In addition to the patent, the Company also has 3-year New Product Exclusivity for its SEASONIQUE product until May 25, 2009.

"We remain committed to enforcing our patent on our SEASONIQUE extended-cycle oral contraceptive product and will pursue all legal means necessary to prevent Watson from launching a generic product prior to patent expiry in 2024," said Bruce L. Downey, Barr's Chairman and CEO.

On January 22, 2008, the U.S. Patent and Trademark Office issued the patent for the Company's SEASONIQUE extended-cycle oral contraceptive. The Company immediately submitted the patent to the U.S. Food and Drug Administration (FDA) for listing in the Orange Book. On January 22, 2008, Watson notified the Company pursuant to the Hatch-Waxman Act that Watson had filed an Abbreviated New Drug Application (ANDA) with the FDA for SEASONIQUE and that Watson had amended its application to include a paragraph IV certification asserting that the SEASONIQUE patent is invalid, unenforceable or not infringed by Watson's ANDA product. Barr has filed to enforce the patent and prevent Watson from marketing a competing product prior to patent expiry in 2024. If Barr is unsuccessful in this litigation, the Company may face generic competition for SEASONIQUE as early as May 25, 2009, the date of expiration of our existing new product regulatory exclusivity for SEASONIQUE.

Sun Pharma gets USFDA tentative approval for generic Gemza injection

March 5, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for its generic version of Eli Lilly and Co’s Gemzar, gemcitabine injection.

These generic gemcitabine injections are therapeutic equivalents of Eli Lilly and Co’s Gemzar® injections availablein two strengths: 200 mg and 1 g single use vial. These strengths of gemcitabine injections have annual sales ofapproximately USD 680 million in the US.Gemcitabine is an anticancer, used singly or in combination with other anticancer agents. Gemzar® is a registered trademark of Eli Lilly and Co.

Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for Xyotax

Cell Therapeutics, Inc. (CTI) announced today that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) who have ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The application is based on a positive opinion CTI received from the EMEA's Scientific Advice Working Party, which agreed to review the application based on the existing results of the phase III clinical trials of XYOTAX, known as the STELLAR trials.

Eisai Announces Vasolan (Ischaemic Heart Disease Treatment) Received Approval for Atrial Fibrillation/Flutter; Paroxysmal Supraventricular Tachycardia

Eisai Co., Ltd. (TSE: 4523) announced today that Vasolan(R) Tablets 40mg (generic name: verapamil hydrochloride) received approval for the additional indications of the treatment of atrial fibrillation/flutter and paroxysmal supraventricular tachycardia. This approval makes Vasolan the first oral form of calcium channel blockers approved for the treatment of tachyarrhythmia in Japan.
Vasolan is a calcium channel blocker with coronary/peripheral vasodilator actions. It has been used to treat ischaemic heart disease for more than forty years. For many years, Vasolan has been used to treat arrhythmia in the U.S. and European countries because of its beneficially effects on heart rate control in artial fibrillation/flutter and stopping/preventing paroxysmal supraventricular tachycardia. In Japan, Vasolan for intravenous injection 5mg that contains the same active ingredients as the oral form tablet has been approved for the treatment of tachyarrhythmia (paroxysmal atrial fibrillation/flutter and paroxysmal supraventricular tachycardia). The additional indications approved today for the oral form of Vasolan will provide a wider range of treatment options for patients who are suffering from tachyarrhythmia.

Patents Awarded

Generex Biotechnology Corporation (Nasdaq:GNBT) announced today that it has received new patents in Canada and Argentina. The Canadian Intellectual Property Office has granted the Company a new patent titled, "Mixed Micellar Pharmaceutical Delivery System and Method of Preparation." The patent contains process, formulation and use claims to a mixed micellar pharmaceutical formulation for buccal administration.

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has received allowance of a second US patent application protecting a novel photoactive analog of its lead photodynamic product PH-10, from the United States Patent and Trademark Office (USPTO). The pending patent covers systemic use of the drug, PH-12, for photodynamic treatment of cancer, skin diseases, and other tissue disorders using visible light activation.

Generic Risperidal - Teva's Update

Mar 4, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that its U.S. subsidiary has filed a lawsuit against the U.S. Food and Drug Administration ("FDA") seeking an order requiring the FDA to relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal(R) (Risperidone) Tablets.

Teva argues that the FDA's denial of Teva's Citizen's Petition, seeking the relisting of U.S. Patent No. 5,158,952 and restoration of Teva's 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful, as Teva disputes that the agency provided legal notice that the patent had been delisted prior to Teva's submission of a Paragraph IV certification to that patent.

Watson Files Application for Generic Seasonique

(Source: Pharmalive.com)
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. Watson's levonorgestrel and ethinyl estradiol product is a generic version of Barr's SEASONIQUE(R).

On January 23, 2008 pursuant to the Hatch-Waxman Act, Watson notified Barr that it had filed an ANDA with a paragraph IV certification with the FDA for a generic version of SEASONIQUE(R) asserting that the SEASONIQUE(R) patent is invalid or not infringed. Based on available information, Watson believes it may be the first applicant to file an ANDA for SEASONIQUE(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

NDAs submitted

Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, announced today that it has filed a new drug submission for SEASONIQUE® with the Therapeutic Products Directorate of Health Canada. SEASONIQUE® is the next generation of extended-cycle oral contraceptives for the prevention of pregnancy. Paladin signed a license and distribution agreement with Duramed Pharmaceuticals, Inc., a wholly owned subsidiary of Barr Pharmaceuticals, Inc. (NYSE:BRL), which granted Paladin the exclusive Canadian license to market SEASONIQUE®.

Takeda Pharmaceutical Company Limited (“Takeda”) today announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan. Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. These receptors are located in suprachiasmatic nucleus, a body’s ‘master clock’, which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, body’s sleep-wake cycle is regulated and physiological sleep is promoted.

PPD, Inc. today confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.

February 28, 2008- Alpharma Inc. (NYSE:ALO), a global specialty pharmaceutical company, today announced that a New Drug Application (NDA) has been submitted for EMBEDA, a pharmacological abuse-deterrent, extended-release morphine product candidate.

AstraZeneca Submits sNDA for Seroquel XR for the Treatment of Major Depressive Disorder

AstraZeneca today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

MDD affects 15 million American adults -- between 5 and 8 percent of the population each year -- and today it is often treated with generic or branded antidepressants.(1) Studies have shown that at least one-third of patients with MDD treated with antidepressants fail to achieve a satisfactory response.(2) The American Psychiatric Association Practice Guidelines recommend switching to a medication in another class when two medications from the same class have proven ineffective.(3) AstraZeneca has investigated the use of SEROQUEL XR, an atypical antipsychotic, in the treatment of MDD, aiming to develop another potential treatment option, including treatment for patients who have failed or had an inadequate response to another antidepressant therapy.

FDA approvals

Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has approved PRISTIQ(TM) (desvenlafaxine), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping PRISTIQ to wholesalers beginning in the second quarter of 2008.

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY(R) (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old). ABILIFY has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.

FDA Approves Aloxi (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting

Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi(R) (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

Aloxi, available in the United States since 2003, is the first and only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by the FDA for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.
The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In the trial, 574 patients undergoing elective gynecologic or abdominal laparoscopic surgery (predominately in the out-patient setting) were randomized to receive one of three single intravenous doses of Aloxi (0.025 mg, 0.050 mg or 0.075 mg) or placebo prior to administration of anesthesia. The effectiveness of Aloxi in PONV was assessed on the day of surgery (0-24 hours) and for two subsequent days (24-72 hours).

Endo Pharmaceuticals to Launch Three New Dosage Strengths of Opana ER

Endo Pharmaceuticals Inc., a market leader in pain management and a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), today announced that the U.S. Food and Drug Administration has approved three new dosage strengths of OPANA(R) ER (oxymorphone HCl) extended-release tablets CII. The new strengths -- 7.5 mg, 15 mg, and 30 mg -- will be available on April 1, 2008 and will join previously approved OPANA ER dosage strengths of 5 mg, 10 mg, 20 mg, and 40 mg. An opioid analgesic, OPANA ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. (See Important Safety Information below.)

"The addition of three new dosage strengths of OPANA ER, complementing the currently available strengths, will make it easier for physicians to titrate patients to the optimal level of pain relief," said David A. Lee, M.D., Ph.D., Chief Scientific Officer. "The new strengths will also facilitate clinicians' ability to convert patients to OPANA ER from other opioid analgesics to which they may not have had an adequate clinical response. Further, the introduction of these new strengths underscores Endo's long-term commitment to the OPANA franchise and to providing physicians with additional treatment options for their appropriate chronic pain patients."

The approval is based on studies demonstrating the safety and efficacy of OPANA ER in its four original strengths. Because the new dosages fall between the available strengths, FDA did not require new safety or efficacy studies.

Procter & Gamble Wins Patent Infringement Lawsuit for Osteoporosis Therapy Actonel

Today the United States District Court of Delaware ruled in favor of The Procter & Gamble Company (P&G) in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals USA, Inc. The positive ruling protects P&G's rights in the U.S. to exclusively market the osteoporosis therapy Actonel(R) (risedronate sodium tablets).

On August 13, 2004 P&G filed a patent infringement lawsuit against Teva to enforce P&G's U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention. Today's Court ruling upheld the P&G patent, expressly rejecting Teva's validity challenge.

"We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule," said Tom Finn, P&G President, Global Health Care. "We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures."

The Actonel patent life extends through the end of 2013, excluding any potential extensions. Actonel was approved in 2000 by the U.S. Food and Drug Administration for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures in just one year.

Barr Announces Favorable Ruling in Yasmin Patent Challenge

Barr Pharmaceuticals, Inc. today announced that the U.S. District Court for the District of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG in connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious.

"We are delighted that Judge Sheridan has invalidated the patent on Yasmin," said Bruce L. Downey, Barr's Chairman and CEO. "We are currently reviewing the opinion in the case and evaluating all of our options. Clearly, this is a positive development for the Company and we are evaluating what the potential impact could be on our earnings guidance for 2008."

Yasmin provides an oral contraceptive regimen consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $572 million for the twelve months ended December 2007, based on IMS sales data.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Yasmin product with the U.S. Food & Drug Administration (FDA) in January 2005, and received notification of the application's acceptance for filing in February 2005. Following receipt of the notice from the FDA, Barr notified Berlex, the New Drug Application (NDA) holder, and Schering AG, the patent owner. In April 2005, Schering AG and Berlex filed a patent infringement suit against Barr in the U.S. District for the District of New Jersey. In June 2006, Bayer AG acquired Schering AG. In November 2007, the patent infringement case was heard in front of Judge Sheridan.

Fournier Laboratories Ireland Ltd and Laboratoires Fournier SA filed patent infringement actions against Teva in the USA

March 3, 2008-Fournier Laboratories Ireland Ltd (LFI) and Laboratoires Fournier S.A. (LFSA), wholly-owned subsidiaries of Solvay Pharmaceuticals, announced today that they have filed patent infringement court actions in the United States against Teva Pharmaceuticals.In January 2008 Fournier was informed by Teva Pharmaceuticals that the latter had filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval of a generic version of TriCor® (fenofibrate) 145mg NFE tablets in the U.S. As part of its application process, Teva submitted a Paragraph IV certification as required by law.

Solvay Pharmaceuticals is fully committed to its fenofibrate franchise and will vigorously protect the intellectual property for this product against any infringement.

Teva Provides Update on Generic Actonel Litigation

Feb 29, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter & Gamble's Actonel(R) (Risedronate Sodium) Tablets, 5mg, 30mg and 35 mg. The Court found Procter & Gamble's U.S. Patent No. 5,538,122 to be valid. Teva intends to appeal this decision.

Actavis Receives Approval for Irinotecan Hydrochloride Injection; Extends US Portfolio with First Injectable Product

Actavis Group, the international generic pharmaceuticals company, has received approval for Irinotecan Hydrochloride Injection from the U.S. Food & Drug Administration. Distribution of the product will begin immediately.
Irinotecan Hydrochloride Injection, the generic equivalent to Pfizer's Camptosar(R) will be available in 40 mg/2 mL and 100 mg/ 5 mL sizes and is used in the treatment of patients with metastatic carcinoma of the colon or rectum. Annual sales of Irinotecan Hydrochloride Injection in the United States were approximately US$556 million for the twelve months ending December 2007 according to IMS Health data.
Doug Boothe, Executive Vice President of US Commercial & Administration, said: "The launch of Irinotecan marks the expansion of Actavis' US portfolio into the injectable pharmaceuticals arena. Actavis has set its sights firmly on the hospital sector and currently has around 300 pending applications worldwide for injectable medicines. Furthermore, Actavis' ambitious pipeline comprises more than 60 new injectable projects, developed both internally and through established relationships with other developers."
Actavis currently markets over 50 hospital products worldwide, with a focus on oncology products and a growing range of anti-infectives, local anesthetics and analgesics.

Teva Introduces Irinotecan Hydrochloride Injection

February 28, 2008 – Teva Health Systems is pleased to announce the introduction and availability of Irinotecan Hydrochloride Injection. This product is AP Rated to Camptosar®* Injection. Irinotecan Hydrochloride Injection is available in 20 mg/mL, 40 mg, and 20 mg/mL, 100 mg in single dose amber polymer vials.“Teva offers a broad range of quality health systems generics from a single source,” states Jonathan Zalk, Director of Marketing. “We are pleased to announce this latest addition to our growing line.”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.