Happy New Year

A Very - Very

Happy New Year 2008

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US FDA accepts Jerini's NDA for HAE drug Icatibant

The US FDA has accepted Jerini AG's New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE). The US Food and Drug Administration also designated the drug for priority review, stated a Jerini AG press release.
Priority review is granted to those products that address significant unmet medical needs and provides for a review period of six months from the date of submission. The FDA has issued an action date of April 26, 2008, under the Prescription Drug User Fee Act (PDUFA) for the NDA.

In addition, the FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting on February 20, 2008, to discuss Icatibant. Advisory committees provide advice to the agency and are often held as part of the review process for first-in-class drugs. Although the committee provides advice to the agency, final decisions are made by the FDA.

"We are very pleased with the successful completion of this important regulatory step and the FDA's decision to include an advisory panel as part of the review process," said Jens Schneider-Mergener, CEO, Jerini. "We are confident that our phase III data demonstrate Icatibant's safety and efficacy in treating HAE, and we look forward to having the opportunity to present our data package to the panel.

" Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. Icatibant has been granted orphan drug status for the treatment of angioedema by the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), potentially securing upon approval, market exclusivity for seven and ten years, respectively.

HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks of the hands, feet, face, larynx, and abdomen. It is estimated that approximately 10,000 patients in the United States and Europe have been diagnosed with HAE. HAE attacks affecting the hands, face, and feet can be disfiguring, while attacks in the gastrointestinal tract result in severe pain caused by swelling of the intestinal wall. Attacks that affect the larynx are life-threatening because swelling of the larynx constricts the upper airways and can lead to death by suffocation. The prevalence of HAE is estimated between one in 50,000 and one in 10,000 individuals, and it is estimated that between 15,000 and 75,000 people are affected with HAE in the European Union and the United States.

Mylan Announces Final FDA Approval for Cetirizine Hydrochloride Tablets

PITTSBURGH, December 28, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

Cetirizine HCl Tablets are the generic version of Pfizer's Zyrtec(R) Tablets, which had U.S. sales of approximately $1.4 billion for the 12 months ending Sept. 30, 2007.

This product will be shipped immediately.

Perrigo Announces FDA Approval for Over-The-Counter Cetirizine Hydrochloride Tablets

ALLEGAN, Mich., December 28, 2007 /PRNewswire-FirstCall/ -- Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.

The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Cetirizine Hydrochloride Tablets, 5 and 10 mg, which will be marketed as Zyrtec(R) Tablets, indicated for allergy and hives relief. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.

Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablet and Zyrtec Hives Relief Tablet

DETROIT, December 28, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets, "over the counter", (OTC), 5 mg and 10 mg, (Cetirizine HCl).

Cetirizine HCl, which will be marketed as two separate OTC products in two strengths of 5 mg and 10 mg, is an antihistamine drug, which is used to treat allergies, hives, and other allergic inflammatory conditions. These new products are the bioequivalent to Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R), registered trademarks of Pfizer, Inc.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to have the opportunity to market these products as they represent the first "over-the counter" products to be added to our current portfolio of prescription products. Zyrtec Allergy(R) has just been approved for the OTC market and we are pleased to be able to market a generic OTC version as an alternative. It previously was marketed strictly as a prescription product under the Zyrtec(R) brand name where it had done over $1.3 billion in prescription sales. We continue to focus on working towards expanding our product offering as quickly and effectively as possible. We plan to market these products to the generic pharmaceutical and OTC market immediately. This will bring our total product selection to 45 different products represented by 96 various strengths."

AstraZeneca Files Patent Infringement Actions in Response to Crestor™ ANDAs

AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™

On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.

Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.

Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.

Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the ‘314 patent). AstraZeneca licenses the ‘314 patent from Shionogi & Co. Ltd.

US FDA extends review period for Genta's melanoma drug Genasense

The Food and Drug Administration (FDA) has extended its review period of Genta Inc's request for correction of certain information that was filed pursuant to the Information Quality Act for an additional 60 days.

The requested correction relates to FDA's assessment of progression-free survival (PFS) in the phase III trial of Genasense (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee (ODAC) that considered Genta's New Drug Application for Genasense in patients with advanced melanoma.

"Melanoma is a key indication in our current phase III development program", said Dr Loretta M. Itri, MD, president for pharmaceutical development and chief medical officer, Genta. "A methodological error may have impacted ODAC deliberations, which voted unanimously that an improvement in PFS of some magnitude represents clinical benefit that could support regular approval in advanced melanoma.

"Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.

Tibotec submits sNDA for Prezista to US FDA

Tibotec, Inc. said it submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the protease inhibitor (PI) Prezista (darunavir). The drug seeks traditional approval and an expanded indication to include human immunodeficiency virus (HIV)-1-infected, treatment-naïve adults.

The application includes 48-week data from two phase III studies, ARTEMIS and TITAN, which were presented at HIV conferences earlier this year, as well as 96-week data from the phase IIb studies, POWER 1, 2, and 3.

Prezista received accelerated approval in June 2006 based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) phase IIb studies. As part of the post-marketing commitment, 48-week data from ongoing phase III studies (ARTEMIS and TITAN) and 96-week data from POWER 1, 2, and 3 are required before the FDA can consider traditional approval for Prezista.

Prezista, co-administered with 100 mg ritonavir and with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of Prezista/ritonavir in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The sNDA submission includes the 48-week efficacy and safety results of Artemis (AntiRetroviral Therapy with TMC114 Examined In naïve Subjects), a phase III, randomised, controlled, open-label study that compared the efficacy and safety of Prezista/r with the PI lopinavir/r in treatment-naïve HIV-1-infected adult patients. Patients were randomised to receive a Prezista/r dose of 800 mg/100 mg once daily (an investigational dose) or, based on approved dosing in each country, either lopinavir/r 800 mg/200 mg once daily or 400 mg/100 mg twice daily, plus an optimized background regimen (OBR) of tenofovir and emtricitabine once daily. Data from this study were presented at the 47thInterscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) in Chicago on September 18, 2007.

The sNDA submission also includes data from TITAN (TMC114/r In Treatment-experienced patients Naïve to lopinavir/ritonavir), a 96-week, phase III, randomised, controlled, open-label study, comparing the efficacy and safety of a Prezista/r dose of 600 mg/100 mg twice daily with lopinavir/r 400 mg/100 mg twice daily, each with OBR, in treatment-experienced HIV-1-infected adult patients who were lopinavir/r-naïve. Forty-eight week data from this study were published in the July 7, 2007, issue of The Lancet and presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention in Sydney, Australia, on July 24, 2007.Prezista does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Coadministration of Prezista/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).

Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving Prezista during the clinical development programme. In some cases, fever and elevations of transaminases have also been reported. In clinical trials, rash (all grades, regardless of causality) occurred in seven percent of subjects treated with Prezista; discontinuation due to rash was 0.3 per cent. Rashes were generally mild-to-moderate, self-limiting and maculopapular.

New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycaemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.

Tibotec, Inc., based in Yardley, Pennsylvania, is a pharmaceutical research and development company, with headquarters in Ireland and an operating affiliate in Belgium. Tibotec Inc., is dedicated to the discovery and development of novel, new drugs for HIV/AIDS and other infectious diseases.

Noven Announces FDA Tentative Approval of Stavzor Valproic Acid Delayed Release Capsules

MIAMI--(BUSINESS WIRE)--Dec 26, 2007 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration (FDA) has issued a tentative approval letter related to the New Drug Application (NDA) for Stavzor(TM) (valproic acid delayed release capsules) in 125mg, 250mg and 500mg strengths. The tentative approval relates to the use of Stavzor(TM) in the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

The FDA states in the letter that it has completed its review of the amended Stavzor(TM) NDA and that it is tentatively approved. "Tentative approval" generally means that the FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.

The NDA for Stavzor(TM), which was submitted by Banner Pharmacaps Inc. (the NDA holder and developer of the product) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories' Depakote(R) product. Based on receipt of the tentative approval letter and Noven's understanding of Depakote(R) exclusivity, Noven continues to expect FDA final approval of Stavzor(TM) by the end of July 2008.

Stavzor(TM) was developed using Banner's patent-pending EnteriCare(TM) enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor(TM) in the U.S. as part of Noven's acquisition of JDS Pharmaceuticals in August 2007. If approved for marketing, Stavzor(TM) will be a branded product; it will not be AB-rated to or generically substitutable for Depakote(R), nor will Depakote(R) or any Depakote(R) generics be substitutable for Stavzor(TM). Promotion of the Stavzor(TM) brand will occur through the Noven/JDS sales force.
"We are very pleased that Banner's response to the FDA's October 2007 approvable letter for Stavzor(TM) was deemed a complete response by the FDA, and that the FDA has granted tentative approval of this important new product for the treatment of three indications," said Robert C. Strauss, Noven's President, CEO & Chairman. "Stavzor(TM) launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization."

FDA's letter does not raise any specific concerns about the safety or efficacy of Stavzor(TM). Noven expects that the product label will contain similar warnings to those described in the Depakote(R) product label, including those relating to life threatening adverse reactions concerning hepatotoxicity, teratogenicity, and pancreatitis.
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatin capsules.
EnteriCare(TM) is a trademark of Banner; Depakote(R) is a registered trademark of Abbott Laboratories or its affiliates.

Suven Obtains First Product Patent from US Patent Office

HYDERABAD, INDIA (Dec. 27, 2007) – Suven Life Sciences Ltd announces today that the US Patent office has granted Product Patent # US 7,297,711 to Suven. This is Suven’s first product patent granted in USA. The granted claims of the patent include the class of selective Serotonin receptor affinity compounds discovered by Suven and are being developed as therapeutic agents. According to the invention ‘711 patent disclosure, the compounds are useful in the treatment of neuro-degenarative disorders like Alzheimer’s, Parkinson, Schizophrenia and Huntington’s.

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

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

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

Suven Life Sciences is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class therapies through the use of GPCR targets. The company has six internally-discovered therapeutic drug candidates currently in pre- clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s’ disease and obesity in addition to developmental candidates in Alzheimer’s disease and Schizophrenia.

Astellas Won the Patent Infringement Suit on Oral Cephalosporin Antibiotic Cefzon Capsule

TOKYO, Dec. 27, 2007-Astellas Pharma Inc. today announced that the Supreme Court has dismissed a final appeal by Taiyo Yakuhin Co., Ltd. against a patent infringement lawsuit for its oral cephalosporin antibiotic cefdinir. It implies that Astellas won this lawsuit.

For the full report, see attachment.

Downloads
AstellasSuit.pdf

U.S. District Court Decision About Eisai's Legal Action Over Aricept ODT ANDA Filing

TOKYO and WOODCLIFF LAKE, N.J., December 27, 2007 /PRNewswire/ --- Eisai Co., Ltd. and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) (collectively "Eisai") filed a lawsuit in August 2006 against Mutual Pharmaceutical Co., Inc. and United Research Laboratories, Inc. (collectively "Mutual") claiming that its submission of an abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) for Aricept ODT(R) (donepezil hydrochloride orally disintegrating tablets) would infringe Eisai's composition of matter patent.

On December 20, 2007 (U.S. EST), the U.S. District Court for the District of New Jersey issued a ruling dismissing the lawsuit against Mutual on the procedural grounds that there is no case or controversy between the parties, because Mutual did not make a certification challenging the patent and does not yet have FDA approval to market its product. The Court recognized that Mutual is required, by a stipulation entered between the parties and signed by the Court, to give Eisai 45 days' notice of any launch of a generic version of Aricept ODT(R), and Eisai may during that 45-day period bring an action against Mutual for patent infringement and seek injunctive relief against Mutual's sales of any such product. Therefore, Mutual cannot market the generic version of Aricept ODT(R) immediately.

The Court did not address the substantive merits of Eisai's infringement action against Mutual. Eisai believes that its donepezil composition of matter patent is valid and enforceable until its expiration date of November 25, 2010, and that Mutual would clearly infringe its donepezil composition of matter patent if Mutual were to launch a generic version of Aricept ODT(R) in the United States prior to the expiration. Eisai intends to vigorously enforce and defend that patent.

The Court's ruling has no impact on Eisai's ongoing infringement action against Teva Pharmaceuticals for its ANDA for generic Aricept(R) (donepezil hydrochloride).

Pfizer gets US FDA approvable letter for Dalbavancin

The pharma major Pfizer has received an approvable letter from US Food and Drug Administration (FDA) for Dalbavancin HCl. This drug is Pfizer's once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

The US regulator recently published a draft guidance on studies designed to show non-inferiority as a basis for approving antibacterial drug products and requested Pfizer to provide additional data with regard to Dalbavancin. Pfizer is working with the FDA to respond to these new requirements.

Also, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third party manufacturer, not specifically related to Dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues. Pfizer is also addressing a question from the FDA regarding length of storage time following reconstitution of Dalbavancin.

Dalbavancin, a member of the Glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.

The company has a long history of developing new medicines for treating infectious diseases and remains committed to providing physicians with this important new treatment option for skin infections caused by MRSA.

MRSA is a virulent and potentially deadly bacterium, and MRSA infections are on the rise in hospitals, long-term care facilities and within communities. MRSA is resistant to many classes of commonly used antibiotics and can cause several types of infections, with skin infections being the most common. The Infectious Diseases Society of America (IDSA) has included MRSA on a reported Hit List of top-priority, dangerous drug resistant microbes that require additional research and new treatments.

Mylan gets US FDA nod for hypertension drug Bystolic

The US Food and Drug Administration has approved the novel beta blocker hypertension drug Bystolic (nebivolol) manufactured by Mylan Inc.

Forest Laboratories, Inc. will market the prescription drug to the US under the name Bystolic and will pay Mylan undisclosed royalty payments as part of their collaboration agreement. . Forest licensed US and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the US. The company expects Bystolic would be available to physicians, patients, and pharmacies in January 2008.

Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. Hypertension affects approximately 72 million adults in the US and 65 per cent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range, underscoring the need for additional therapeutic options.

Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 per cent Black, 54 per cent male, 19 per cent elderly and 8 per cent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.

"Bystolic is the newest beta blocker approved for the treatment of hypertension in the US and should prove useful due to its efficacy in a broad range of patients and its favourable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."

Howard Solomon, chairman and chief executive, Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."

Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the US and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.

Patients being treated with Bystolic should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of therapy with beta blockers. When discontinuation is planned, the dosage should be reduced gradually over a one to two week period and the patient carefully monitored.

Bystolic is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.Like other beta blockers, Bystolic should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. The most common adverse events with Bystolic were headache, fatigue and dizziness.

Jazz receives US FDA approvable letter for Luvox CR

Jazz Pharmaceuticals Inc., a specialty pharmaceutical company focused on identifying, developing and commercialising innovative products to meet unmet medical needs in neurology and psychiatry, received an approvable letter from US FDA for its once-a-day Luvox CR (fluvoxamine maleate) extended-release capsules.

For Luvox CR (fluvoxamine maleate) extended-release capsules Jazz and Solvay are seeking marketing approval for the treatment of two anxiety disorders - social anxiety disorder (SDA) and obsessive compulsive disorder (OCD), according to the company sources

However, FDA has requested information related to the companies' response concerning the previously disclosed CMC issue. The companies are seeking clarification from FDA and look forward to working with FDA to resolve this as quickly as possible.

The approvable letter did not raise any questions related to safety or efficacy of Luvox CR. The approvable letter included the FDA's proposed labelling.

The FDA approved Luvox (fluvoxamine maleate) for the treatment of OCD on December 20, 2007.

Roche's anti-cancer drug Avastin gets approval in Europe

Roche's innovative anti-cancer drug, Avastin (bevacizumab), was approved in Europe for the first-line treatment of patients with advanced renal cell cancer (RCC) in combination with interferon (IFN), the current standard of care1.

The approval was based on data from the pivotal phase III AVOREN trial, which showed that patients with advanced RCC who received Avastin in combination with IFN lived nearly twice as long without their disease progressing ("progression free survival"), as those who received IFN alone.

Kidney cancer, known as renal cell carcinoma (RCC) is a disease that kills over 100,000 people per year world-wide2.

There are few early symptoms in kidney cancer which means that unfortunately the majority of patients are diagnosed with advanced disease, where current treatment options are limited. Kidney cancer is highly resistant to chemotherapy and radiotherapy, which are often key weapons against other cancer types3.

"The approval by European health authorities is a significant step forward in the treatment of advanced renal cell cancer. Avastin effectively doubles the time in which patients live without their disease getting worse, so this approval has the potential to change the treatment landscape for this disease, where treatment options have been limited" said William M. Burns, CEO, Pharmaceutical Division, Roche.

Kidney cancer is the fourth cancer type in which Avastin has demonstrated positive survival benefits for patients. Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, breast, lung, and kidney cancer:

The AVOREN study is a randomised, controlled, double-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.

The results of the AVOREN trial showed that by adding Avastin to IFN a progression free survival (PFS) was almost doubled from a median of 5.4 to 10.2 months while the tumour response was significantly increased from 12.8 per cent with IFN alone to 31.4 per cent when Avastin was added. Dose-reduction of IFN did not appear to affect the efficacy of the combination with Avastin (based on PFS event free rates over time, as shown by a sub-group analysis). The study also showed a trend towards improved overall survival; however, these data are still pending. No new or unexpected adverse events were observed.

An interim analysis of AVOREN was performed in December 2006 and the benefits provided by Avastin were so positive that the Drug Safety Monitoring Board recommended that the trial was unblinded and all patients were offered treatment with Avastin. The study demonstrated for the first time that Avastin benefits patients in combination with an immunotherapeutic, the class of drugs to which IFN belongs.

Kidney cancer is more common in men than women (approximately 62 per cent of patients with kidney cancer are men) and incidence increases with age2.

As the most common type of kidney cancer, RCC accounts for approximately nine out of ten cases of the disease4. Within this cancer type, there are several sub-types of cancer based on looking at the cells under a microscope. Clear cell renal cell cancer is the most common type. If RCC is diagnosed at an early stage when the cancer is still confined to the kidney, the 5-year survival rates are relatively good at 60 to 75 per cent. However, if diagnosis is made at a later stage and the cancer has already spread to distant sites the 5-year survival rate is less than 5 per cent. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages.

Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but is only really successful in early stage disease. In later stage disease, treatment is more often employed with a view of controlling the cancer and improving associated symptoms.

Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called vascular endothelial growth factor (VEGF), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic, ovarian, renal cell cancer, and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.

Wyeth to sue Teva over generic version of Protonix

The patent dispute over Protonix rewed up when Wyeth Pharmaceuticals said it would pursue a patent infringement claim for lost profits and other damages against Teva Pharmaceuticals USA, Inc after Teva launched the generic version of Wyeth's top-selling heart burn drug Protonix.

"Teva has not disputed that its product infringes the United States Protonix compound patent exclusively licensed to Wyeth by Altana, recently acquired by Nycomed," said Lawrence V. Stein, senior vice president and general counsel, Wyeth. "We believe our patent is valid and enforceable and that Teva will be required to compensate Wyeth for the substantial damages caused by Teva's violation of our patent rights."

On September 6, 2007 the United States District Court for the District of New Jersey denied Wyeth and Altana's motion for a preliminary injunction against the launch of a generic pantoprazole tablet by Teva and Sun Pharmaceuticals prior to resolution of a pending patent infringement proceeding. Although Teva and Sun did not dispute that such a launch would infringe the Protonix patent, the court found that the defendants had raised sufficient questions about the validity of the patent to preclude the issuance of the extraordinary remedy of a preliminary injunction. The court did not conclude that the patent was invalid and emphasized that its findings were preliminary. The court stated that at trial, the generic companies would face the higher burden of demonstrating by clear and convincing evidence that the patent is not valid. At trial, Wyeth will seek to recover its lost profits and other damages resulting from Teva's infringing sales and a permanent injunction against future sales of generic pantoprazole prior to expiration of the Protonix patent.

The patent will expire in July 2010, but Wyeth's marketing exclusivity may be extended until January 2011 as a result of clinical research undertaken by the company regarding the paediatric use of the product.

Sales of Protonix for the first nine months of 2007 totalled approximately $1.4 billion.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.

Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis

COLLEGEVILLE, Pa., December 24, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis.

In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by the Company's complete response to the first approvable letter. The FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events. The Agency also identified certain issues concerning data collection and reporting and requested additional source documents.

The FDA stated that the Wyeth Asian studies that were submitted on November 9 and December 14, 2007, were not reviewed for this action. Wyeth believes the data from these nearly 1,000 women provide additional support for a favorable benefit to risk ratio for bazedoxifene in the prevention of postmenopausal osteoporosis.

The Agency did not request the initiation of any new studies and has suggested an end-of-review conference between Wyeth and the FDA to address the remaining issues.
"We look forward to working with the FDA to resolve these issues. Wyeth is dedicated to identifying therapies for the millions of postmenopausal women who are at risk for increased bone loss," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals.

The Company received the first approvable letter on April 23, 2007, and submitted data requested in June 2007. In July 2007, Wyeth submitted a separate New Drug Application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis, which was accepted for filing in September 2007, with an action date in May 2008.

Eisai Introduces New Aricept Dose Formulations for Treatment of Severe Alzheimer's Disease in Japan

TOKYO, Dec. 25, 2007-Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) today announced that the company will introduce new dose formulations of Aricept® (donepezil hydrochloride), Aricept® Tablet 10 mg and Aricept® D Tablet 10 mg, for treatment of severe Alzheimer's disease (AD) in Japan on December 26, 2007.

On August 23, 2007, Eisai obtained approval for additional efficacy and dosage for Aricept® for the treatment of severe AD as well as for the marketing authorization for the new 10 mg dose formulations in Japan. The new 10 mg dose formulations were added to the National Health Insurance (NHI) drug price list as of December 21, 2007.

In the treatment of severe AD, dose of Aricept® is increased to 10 mg once daily, after four weeks and later at 5 mg. Currently, Aricept® is marketed in 3 mg tablet or 5 mg tablet formulations. With introduction of 10 mg tablets, one tablet a day administration treatment becomes available for all stages of AD (mild, moderate and severe) which can be beneficial for the patients and their families, as well as their caregivers.

Dr. Reddy`s gets tentative nod for generic Protonix

The Hyderabad-based company has been granted the tentative approval by the USFDA to sell tablets of Pantoprazole Sodium, or generic Protonix, in multiple strengths.

Dr. Reddy's Laboratories Ltd., one of the leading pharmaceutical companies in India, has received a tentative approval from the US Food and Drug Administration (USFDA) to sell a generic version of Wyeth's heartburn drug Protonix.

The Hyderabad-based company has been granted the tentative approval by the USFDA to sell tablets of Pantoprazole Sodium, or generic Protonix, in multiple strengths, the US drug regulator said on its web site.

Wyeth seeks reimbursement of lost profit from Teva's generic launch of Pentoprazole

A patent dispute over the heartburn drug Protonix escalated Monday when Wyeth said it will sue to recover lost profits from sales of Teva Pharmaceutical Industries Ltd.'s generic version.The US4758579 which covers Fluoroalkoxy substituted benzimidazoles useful as gastric acid secretion inhibitors including petoprazole as product. The patent is set to expire in July 2010, though Wyeth could extend the date to 2011 if it seeks a pediatric use for the drug. Protonix had sales of $1.4 billion during the first nine months of 2007.Meanwhile, the companies are still discussing a possible settlement and Teva said it is voluntarily halting additional shipments of the generic drug for 30 days.Teva has already been awarded a 180-day period of market exclusivity for being the first company to file for a generic version of the drug, which the U.S. Food and Drug Administration approved in August.Wyeth estimated that Teva likely began shipping the generic drug Friday and, in a conference call, several analysts expressed concern that Teva's launch may have been substantial.In its own conference call, Teva categorized the Protonix launch as "relatively full" but limited to the United States. Most shipments won't be received until after the new year and will be included in the 2008 financial results. Teva did not provide additional details on the launch.The companies are already embroiled in a patent infringement lawsuit over the drug. In September, a federal judge in New Jersey denied a motion by Wyeth and its partner Altana Pharma AG to halt sales of Teva's generic version. While Teva is not disputing it infringed the patent, it is arguing the patent itself is not valid.Both Wyeth and Altana have already filed an appeal over the denied injunction. The drug was licensed to Wyeth by Altana, which was recently bought by Nycomed Holding AS.Wyeth president Bernard Poussot said the company will stand by its position that the patent is valid and enforceable while heading into further Teva negotiations."We are going to use the days ahead to assess our best options," he said in a conference callWyeth expects the patent trial to start in the second half of 2008 and said the lawsuit raises significant revenue challenges in the New Year. The company will revise its 2008 business plan and guidance in January.Sun pharma and Schwarz Pharma are the other two para IV filers.

Teva Announces Launch of Generic Protonix(R) Tablets, 20 mg and 40 mg

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that it has commercially launched Pantoprazole Sodium Delayed Release (DR) Tablets, 20 mg and 40 mg, which are AB-rated to Wyeth's erosive GERD treatment Protonix® DR Tablets. The brand product had annual sales of approximately $2.5 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data. As one of the first companies to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity. Teva is currently involved in patent litigation with Wyeth and Altana concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set. In September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva's Pantoprazole Tablets. Wyeth and Altana have filed a notice of appeal. Following the denial of the preliminary injunction, and a thorough review of the Court’s opinion, Teva accelerated launch preparations for its product, which had already been granted final approval by the U.S. Food and Drug Administration (FDA) on August 2, 2007. Teva and Wyeth/Altana have commenced settlement discussions regarding this product and, to facilitate such discussions, have entered into a standstill agreement pursuant to which Teva agreed not to ship additional product for a period of 30 days. Although the Company expects that the majority of Pantoprazole units will be reflected in its 2008 results, it cannot currently assess the impact of this product on its 2008 financial performance. Based on this launch and on the data available at this time, and in light of its practice of risk-adjusting forecasts for potential launches, the Company is increasing its previous guidance for 2007 fully diluted earnings per share to $2.34 to $2.36, up from reaching the higher end of $2.20 to $2.30.

Pfizer Receives Approvable Letter from FDA for Dalbavancin

NEW YORK--(BUSINESS WIRE)--Dec 21, 2007 - Pfizer Inc today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) issued for dalbavancin HCl, Pfizer's once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

The FDA recently published a draft guidance on studies designed to show non-inferiority as a basis for approval of antibacterial drug products and has requested that Pfizer provide additional data with regard to dalbavancin. Pfizer is working with the FDA to respond to these new requirements.

Separately, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third-party manufacturer, not specifically related to dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues.
Pfizer is also addressing a question from the FDA regarding length of storage time following reconstitution of dalbavancin.

Dalbavancin, a member of the glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.
Pfizer has a long history of developing new medicines for treating infectious diseases and remains committed to providing physicians with this important new treatment option for skin infections caused by MRSA. FDA-approved products, including Pfizer's ZYVOX(R) (linezolid IV/Oral), are currently available for the treatment of complicated skin and skin structure infections caused by MRSA.

MRSA is a virulent and potentially deadly bacterium, and MRSA infections are on the rise in hospitals, long-term care facilities and within communities. MRSA is resistant to many classes of commonly used antibiotics and can cause several types of infections, with skin infections being the most common. The Infectious Diseases Society of America (IDSA) has included MRSA on a reported Hit List of top-priority, dangerous drug resistant microbes that require additional research and new treatments.

GSK acquires heart drug specialist Reliant for $1.65bn

GlaxoSmithKline had completed its $1.65 billion buyout of heart drug specialist Reliant Pharmaceuticals after the US Federal Trade Commission's early termination of its anti trust waiting period.

With the completion of the deal, Reliant's cardiovascular medicines join the GSK portfolio in the US. These include Lovaza (omega-3-acid ethyl esters), an FDA-approved treatment for adult patients with very high levels of triglycerides. Triglycerides are fatty substances in the blood associated with increased risks of coronary artery disease.

Lovaza (formerly known as Omacor) is indicated as an adjunct to diet to reduce triglyceride levels in adults with very high (=500 mg/dL) triglyceride levels. In the nine months ending September 30, 2007, net sales of Lovaza were $206 million, an increase of 115 per cent over the first nine months of 2006.

GSK acquired Reliant, based in Liberty Corner, NJ, for $1.65 billion (£800 million) in cash and expects the transaction will be slightly accretive to earnings in 2008, excluding integration costs, and will create additional value in following years.

"We're eager to begin building on Reliant's success with Lovaza," said Chris Viehbacher, president, US Pharmaceuticals, GSK. "We think this medicine has significant potential to help larger numbers of patients, and we expect it to become an important driver of sales growth in the US."

The acquisition gives GSK marketing rights to Lovaza in the US and Puerto Rico. Pronova BioPharma ASA (Oslo:PRON), the compound's originator, has licensed rights in other markets to several other companies.

In addition to Lovaza, three other cardiovascular products marketed by Reliant will join the GSK portfolio in the US. They are DynaCirc CR (isradipine) and InnoPran XL (propanolol HCl), which treat high blood pressure, and Rythmol SR (propafenone), which treats abnormal heart rhythms, or arrhythmia.

Isentress (raltegravir) from MSD, First Integrase Inhibitor, Approved by the European Union Commission

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck Sharp & Dohme (MSD) announced today that ISENTRESS® (raltegravir) has been granted a license from the European Union Commission (Commission) by way of a decision for use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy (ART). The Commission's decision is applicable to the 27 Member States of the European Union (EU), including France, Germany, Italy, Spain and the United Kingdom. Separate national licenses, based on the Commission's Decision, will also be issued in European Economic Area Member States Iceland and Norway. Raltegravir is the first approved integrase inhibitor, a new class of ART that works by targeting the integrase enzyme, which is essential for HIV replication.

The Commission’s decision, reflecting the positive opinion of the European Medicines Agency, was based on efficacy and safety data from two double-blind, placebo-controlled trials of 24 weeks duration in treatment-experienced patients. In these studies raltegravir, in combination with optimised background therapy (OBT), significantly reduced HIV RNA viral load (p<0.001), and significantly increased CD4 cell counts (p<0.001). The efficacy and safety of raltegravir have not been established in treatment-naïve adult patients or paediatric patients, although studies in these populations are underway.

“Raltegravir is an important new advancement in the treatment of HIV, because it is the first therapy in a new class of drugs that attacks the virus in a completely different way from other available medicines,” said Ken Frazier, executive vice president and president, Global Human Health, Merck & Co., Inc. “This approval marks another milestone in MSD's continued commitment to combating HIV and AIDS by conducting research for breakthrough medicines, developing business models that help our products reach as many people as possible, and participating in partnerships to help build infrastructure and address health and development challenges around the world."

Despite the availability of drugs to treat HIV and AIDS, the pandemic continues. In the EU, nearly 250,000 cases of HIV have been reported since 2002, according to the European Centre for the Epidemiological Monitoring of HIV and AIDS. Additionally, resistance to current HIV therapies in treatment-experienced patients has been noted in numerous international studies, suggesting that resistance to at least one class of antiretroviral agents may be as high as 76 percent. The World Health Organisation (WHO) has called resistance an emerging public health concern and has partnered with the International AIDS Society to develop the Global HIV Drug Resistance Surveillance Network to track emerging resistance patterns in developing and developed countries.

“Treatment-experienced HIV patients have limited options for therapies that are well-tolerated and can reduce viral loads while boosting CD4 counts,” said Jürgen Rockstroh, professor of medicine and head of the HIV Outpatient Clinic, University of Bonn, Germany. “The approval of raltegravir in the EU represents a significant scientific advancement, but more importantly, it addresses a much-needed evolution in the treatment of HIV and AIDS.”

Reduction in viral load and increase in CD4 cell counts

Raltegravir is being studied in two ongoing Phase III multi-centre, double-blind, randomised, placebo-controlled studies (BENCHMRK-1 and BENCHMRK-2) in 699 treatment-experienced adult patients with documented resistance to at least one drug in each of three classes [nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)] of ARTs. Raltegravir 400 mg taken twice daily in combination with OBT was significantly (p<0.001) more effective at both reducing levels of HIV RNA and increasing CD4 cell counts in these patients, when compared to a regimen of placebo plus OBT. The efficacy responses were evaluated based upon the 699 patients from the pooled studies who had completed 24 weeks of treatment or discontinued earlier.

The studies showed that after 24 weeks of therapy, 75 percent of patients (347 out of 462) receiving raltegravir in combination with OBT achieved HIV RNA load reduction to below 400 copies/mL, compared to 40 percent of patients (95 out of 237) receiving placebo plus OBT. In addition, after 24 weeks of therapy, 63 percent of patients (289 out of 462) receiving raltegravir plus OBT achieved viral load reduction to below 50 copies/mL, compared to 34 percent of patients (80 out of 237) receiving placebo plus OBT. After 24 weeks of therapy, increases in CD4 cell counts from baseline were 84 and 37 cells/mm3 for patients receiving raltegravir plus OBT and for those receiving placebo plus OBT, respectively.

Raltegravir is a single 400 mg tablet taken twice daily without regard to food. Raltegravir does not require boosting with ritonavir. In Phase II and III clinical trials, the side effect profile was comparable with placebo. The most common side effects are diarrhoea, nausea, headache and pyrexia.

The United States Patent and Trademark Office Orders the Re-Examination of Two Patents Included in the Patent Litigation between Illumina and Affymetr

SAN DIEGO--(BUSINESS WIRE)--Dec 21, 2007 - Illumina, Inc. (NASDAQ:ILMN) announced today that the United States Patent and Trademark office has ordered the re-examination of U.S. Patent Nos. 6,355,432 and 6,646,243. The serial numbers for the re-examinations are 90/008,885 and 90/008,889, respectively. They were assigned the same filing date of November 27, 2007. The 6,355,432 and 6,646,243 patents are two of the patents currently the subject of the infringement suit Affymetrix, Inc. filed against Illumina on July 26, 2004 in U.S. District Court for the District of Delaware under Civil Action No. 04-901-JJF.

Any person may at any time request that the U.S. Patent Office re-examine a patent on the basis of prior art. The request for re-examination must explain the relevance of the prior art being brought to the attention of the Patent Office, and the manner of applying the cited prior art to every claim for which reexamination is requested. In its request for re-examination of the '432 and 243 patents Illumina has asked the Patent Office to re-examine all of the patent claims. Once, as in this case, the Patent Office has found that the cited prior art raises a substantial new question of patentability, the re-examination process typically takes about one year.

Detailed information about these re-examinations can be found on the U.S. Patent Office website which can be accessed at http://portal.uspto.gov/external/portal/pair. The U.S. Patent Office has yet to rule on the other requests for re-examination filed by Illumina regarding the three other patents that are the subject of the 2004 suit.

"We are pleased to hear that the U.S. Patent Office has decided to re-examine the validity of these two patents. We expect the Patent Office to consider closely the applicability of the prior art in their evaluation of whether these patents should be amended or invalidated in their entirety," said Jay Flatley, President and Chief Executive Officer of Illumina.

Teva Introduces Ceftriaxone for Injection, USP

IRVINE, California, December 21, 2007 - Teva Health Systems is pleased to announce the introduction and availability of Ceftriaxone for Injection, USP. This product is AP rated to Rocephin®* for Injection. Ceftriaxone for Injection is available in 250 mg/vial, 500 mg/vial, 1 gm/vial, and 2 gm/vial, in single dose glass vials, and 10 gm/vial in multiple dose glass vials. “Teva Health Systems is committed to providing high-quality, cost-effective pharmaceuticals to our customers and patients,” states Jonathan Zalk, Marketing Director. “We are excited to offer Ceftriaxone for Injection to meet their needs.”

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.‡

Suven Stepped into Indian ‘NCE’ Patent Wagon, Joins Glenmark

Hyderabad-based drug manufacturing company Suven Life Sciences lately stepped into Indian 'NCE' Patent Wagon joining Mumbai-based drug Research Company Glenmark for receiving Indian patent for New Chemical Entity (NCE) indigenously researched and developed by the Indian company. The Chennai Patent Office issued Indian Patent No. 209540 to Suven for substituted 3-aminoalkoxyindoles as 5-HT (Serotonin) receptors against the mail-box Application No. 883/MAS/2002 filed November 28, 2002. Suven has also made a corresponding US patent filing via PCT National Phase published as US20060173193 dated August 03, 2006. According to the '193 publication, the compounds are suggested to have reach through indication over the treatment of certain CNS disorders such as, anxiety, depression, convulsive disorders, obsessive-compulsive disorders, migraine headache, cognitive memory disorders e.g. Alzheimer's disease and age-related cognitive decline, ADHD (Attention Deficient Disorder/Hyperactivity Syndrome), personality disorders, psychosis, paraphrenia, psychotic depression, mania, schizophrenia, schizophreniform disorders, withdrawal from drug abuse such as cocaine, ethanol, nicotine and benzodiazepines, panic attacks, chronobiological abnormalities, circadian rhythms, anxiolytic, osteoporosis, ischemic stroke, lower the risk of SIDS in young infants with low endogenous melatonin levels, reproduction, glaucoma, sleep disorders (including disturbances of Circadian rhythm) and also disorders associated with spinal trauma and/or head injury such as hydrocephalus. Compounds are further expected to be of use in the treatment of mild cognitive impairment and other neurodegenerative disorders like Alzheimer's disease, Parkinsonism and Huntington's chorea. The compounds are also expected to be of use in the treatment of certain GI (Gastrointestinal) disorders such as IBS (Irritable bowel syndrome) or chemotherapy induced emesis.

BioMarin reacquires rights for tetrahydrobiopterin from Merck

BioMarin Pharmaceutical Inc. re-acquired the Canadian rights for tetrahydrobiopterin (BH4), including Kuvan (sapropterin dihydrochloride), from Merck Serono, a division of Merck KGaA.

The terms of the agreement specify a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed cap.

Kuvan is an oral small molecule for the treatment of phenylketonuria (PKU) developed in partnership with Merck Serono. Based on published literature, there are approximately 1,200 to 1,500 people under the age of 40 with PKU in Canada.

"Acquiring rights to Kuvan in Canada allows BioMarin to better coordinate commercialisation efforts in the North American market," said Stephen Aselage, Senior Vice President, Global Commercial Development, BioMarin. "This agreement with Merck Serono comes at an exciting time for the company and the PKU community after Kuvan was approved in the United States last week.

"Kuvan (sapropterin dihydrochloride) Tablet is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.

The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. BioMarin and Merck Serono estimate that Kuvan could be a potential treatment option for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in the developed world.

Kuvan has received orphan drug designation from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan has received seven years of market exclusivity in the United States. In November 2007, Merck Serono submitted a Marketing Authorization Application (MAA) to the EMEA for sapropterin dihydrochloride as an oral treatment for patients suffering from HPA due to PKU or BH4 deficiency. If approved in the EU, it will receive 10 years of market exclusivity for this indication.

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase. PAH is required for the metabolism of phenylalanine, an essential amino acid found in most protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe mental retardation and brain damage, mental illness, seizures, tremors, and limited cognitive ability.

Lilly ties up with Ambrx for drug discovery

Eli Lilly and Company entered into a collaboration agreement with the privately held Ambrx Inc. to discover and develop novel treatments in several therapeutic areas, including metabolic diseases, central nervous system disorders and other diseases.

The collaboration will apply Ambrx's unique protein optimisation technology, Recodetm, with Lilly's expertise in biologics discovery, development and commercialisation to pursue first-in-class or best-in-class drug candidates, including therapeutic antibodies and improved variants of native proteins, a company press release said.

"We are pleased to enter into this agreement with Lilly, a biologics leader with a proven ability to launch successful medicines in areas of strategic interest to Ambrx," said Stephen W. Kaldor, Ph.D., president and chief executive officer, Ambrx. "This new collaboration allows us to use our existing Recodetm technology to produce high quality protein clinical candidates while simultaneously affording us the ability to expand our reach into new areas such as therapeutic antibodies. In addition, this agreement will further solidify Ambrx's financial condition for the next several years."

Under the terms of the agreement, Ambrx will receive an initial upfront payment and ongoing research support payments. Ambrx may also receive potential research and development milestones and, if assets resulting from the collaboration are successfully commercialised, Ambrx would receive additional milestones and royalties. Other terms of the deal were not disclosed. This collaboration builds on an earlier agreement signed between the two companies in January 2007.

"Lilly continues to be impressed with the technical breadth and depth of the Ambrx scientific staff," commented Thomas Bumol, M.D., Lilly vice president, biotech discovery research and president of Lilly's Applied Molecular Evolution subsidiary. "By leveraging Ambrx technology with our protein engineering capabilities, we hope to accelerate the development of several promising compounds in our pipeline."

Ambrx Inc. is a biopharmaceutical company focused on the discovery and development of first-in-class and best-in-class BioSuperior, protein-based drugs. Using its technology, the company can overcome the performance limitations of high-value commercial proteins by improving their efficacy, safety and ease of use.

Jubilant, Hikal drop out of race for Pfizer's Ireland unit

At least two Indian companies, Jubilant Organosys and Hikal Pharma, have dropped out of the race to acquire Pfizer's Ireland unit. However, other companies such as Nicholas Piramal and Dr Reddy's Laboratories (DRL) could still be in the fray.

Pfizer's European unit is a manufacturing centre for the US-based global major, which it decided to sell earlier this year. A group of Indian companies, mostly those focussed on contract manufacturing, are in the race to buy the asset, estimated to be between $60 and $100 million.

Pfizer to acquire biotherapeutics company CovX

In a move to boost its pipeline of biotech products, Pfizer Inc inked an agreement with CovX to acquire the privately-held biotherapeutics company.

Financial terms which is expected to close in the first quarter were not disclosed.

With the deal, Pfizer is looking forward to the completion of its new Biotherapeutic and Bioinnovation Centre based in California. Based in La Jolla, California, CovX will operate as a division of Pfizer's new Biotherapeutic and Bioinnovation Centre, the company said in a recent press statement.

"The acquisition of CovX is a further step in Pfizer's strategy to acquire and identify new product candidates that we can put into development, leveraging both Pfizer's expertise and that of world-class scientists charged with discovering and bringing in new compounds," said Jeffrey Kindler, chairman and chief executive officer, Pfizer. ". We are looking for the best science wherever we can find it, with a special focus in our priority areas, such as biotherapeutics.

" CovX's biotherapeutic platform is a technology that links therapeutic peptides to an antibody "scaffold". The peptide targets the disease while the antibody scaffold allows the peptide to remain in the body long enough to achieve therapeutic benefit. The technology thereby allows half-life extension and bioavailability to support optimal dosing regimens for peptide therapeutics.

As validation of this technology, CovX has generated three early- stage compounds, one diabetes and two oncology compounds, that are expected to further strengthen Pfizer's biologic pipeline portfolio.

"This deal demonstrates Pfizer's ongoing commitment to build a competitive biotherapeutics enterprise through the acquisition of talented scientists, promising product candidates and a cutting edge technology platform," said Dr. Corey Goodman, president, Biotherapeutic and Bioinnovation Centre, Pfizer. "CovX scientists will remain in place, which reflects our decision to partner differently and maximize the productivity of the research initiatives underway outside of our walls."

"We are pleased to transition the CovX technology to Pfizer's Biotherapeutic and Bioinnovation group and are confident they have the vision and resources to scale the platform and realize the opportunity to make efficacious drugs which will make a difference in peoples' lives," stated Shehan Dissanayake, chairman, CovX and CEO, Tavistock Life Sciences. The acquisition is subject to customary closing conditions (including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976), and is expected to close in the first quarter of 2008.

Indevus Receives Non-Approvable Letter From FDA for Valstar

VALSTAR-specific Issues Have Been Resolved; Remaining Issues Pertain to cGMP Compliance of Third-party Manufacturing Facility

LEXINGTON, Mass., December 19, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for Valstar(TM) related to its chemistry, manufacturing and controls (CMC) NDA supplement submitted to the FDA in May 2007. The letter was received following the Company's response to an August 2007 approvable letter.

The VALSTAR-specific issues that caused the 2002 withdrawal of the product from the market have been satisfactorily resolved. However, during a recent FDA pre-approval inspection of the Company's third-party manufacturing facility for VALSTAR, deficiencies were identified that require resolution prior to approval. The Company believes that successfully addressing the deficiencies at the manufacturing plant is the only remaining item for product approval. Upon resolution, which the Company expects to occur within several months, the Company will respond to the FDA and request re-inspection of the facility.

"We and our third-party manufacturer firmly believe we will be able to resolve the open cGMP issues within the next several months," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "We have been in direct communication with the FDA and they have committed to working closely with us and our manufacturer to resolve the open cGMP issues in an expeditious manner. They appreciate the need and desire to return VALSTAR, currently on the FDA Drug Shortages List, to the market as quickly as possible."

VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette- Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder. VALSTAR was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List. Indevus acquired VALSTAR through its acquisition of Valera Pharmaceuticals and after completing the resolution of the impurity issue, submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007.

GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder

Application Data Show PROMACTA Significantly Raised Platelet Counts and Lowered Bleeding Risk in Clinical Trials for the Short-Term Treatment of Patients with Chronic Idiopathic Thrombocytopenic Purpura (ITP)

PHILADELPHIA and LONDON, December 20, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval to market PROMACTA(TM) (eltrombopag). If approved, eltrombopag would be the first oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding. Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.(1,2) Eltrombopag is an investigational, once-daily oral treatment that induces the proliferation and differentiation of cells in the bone marrow to produce platelets.

"Patients with chronic ITP do not have a treatment option that offers the convenience of an oral platelet growth factor," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GSK is pleased with the data provided to support the NDA and hopeful that, if approved, PROMACTA may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease."

GSK also plans to submit a Marketing Authorization Application (MAA) for eltrombopag in Europe in 2008.

Eurand Completes New Drug Application for Zentase

PHILADELPHIA, Dec. 20, 2007 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that it has completed the filing of its New Drug Application (NDA) with the Food and Drug Administration (FDA) for Zentase(tm) (EUR-1008), the Company's lead product candidate for the treatment of exocrine pancreatic insufficiency (EPI).

Eurand initiated its rolling NDA submission in June 2007 and was granted fast-track designation by the FDA.
In the NDA, the Company included results from two Phase III trials, one pivotal trial, and a supportive trial of Zentase in pediatric patients. Also included in the NDA were results from a gastrointestinal (GI) bioavailability study of Zentase conducted in chronic pancreatitis patients in the U.S., which was completed in November 2007.

Gearoid Faherty, Chief Executive Officer of Eurand, commented, "The completion of our NDA filing for Zentase marks an important milestone for Eurand. With the file now under review, our current focus is on the build out of our Sales and Marketing infrastructure for the anticipated launch of Zentase and integrating the recently announced SourceCF acquisition."

Zentase is a porcine-derived pancreatic enzyme replacement therapy which is being developed to treat EPI, a condition associated with cystic fibrosis (CF), chronic pancreatitis and other conditions. The product is a highly stable formulation that includes eight key enzymes and a number of coenzymes and cofactors and is biologically similar to endogenous human pancreatic secretions necessary for proper human digestion

Abbott's Humira Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis

In Clinical Trials, Patients Taking HUMIRA Saw Significant and Sustained Skin Clearance

ABBOTT PARK, Ill., December 20, 2007 /PRNewswire-FirstCall/ -- Abbott has received marketing authorization from the European Commission for the use of HUMIRA(R) (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis. In one clinical trial, more than 80 percent of patients taking HUMIRA achieved skin clearance of 75 percent or better and in another, almost three quarters of patients achieved 75 percent clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90 percent clearance as early as 16 weeks into treatment. Psoriasis is the fifth approved indication for HUMIRA in the European Union. A regulatory application for HUMIRA to treat psoriasis is also under review with the U.S. Food and Drug Administration.

"Psoriasis is not only a skin disease -- it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment," said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "HUMIRA is the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists to treat this disease."

Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis. Patients may also suffer from poor self-image and social isolation.

"Patients taking HUMIRA for psoriasis experienced rapid, significant skin clearance and maintained improvement for up to a year," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "This fifth indication for HUMIRA demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn's disease and now psoriasis."

New patent law has consequences for the pharmaceutical industry

SURREY, England, 20th December 2007 - On 13th December 2007 a revised version of the European Patent Convention (EPC) came into force. This new law, known as EPC2000, has a number of consequences for the pharmaceutical industry and the way in which patent applications are examined. In addition to implementation of EPC2000, the London Agreement is expected to enter into force in the early part of 2008. Once in force, the London Agreement will greatly reduce the costs associated with validating a granted European patent in the designated states.

According to the European Patent Office (EPO) EPC2000 will bring the EPC up-to-date with the latest legal developments concerning patents internationally, will retain the time-tested structure and the high standards of quality for which the system in known and is intended to make the procedures before the EPO quicker, clearer and more efficient.

* Format for Allowable Patent Claims

Under the old law, if an invention related to a new medical use for a known compound, it was necessary to formulate the claims into the so-called "Swiss-type" format, i.e. "Use of a substance or composition X in the manufacture of a medicament for therapeutic application Y".

In contrast, under the new law, such a claim format is no longer necessary and for the first and each subsequent medical use of a compound or composition the more straightforward language of "Substance or composition X for use as a medicament" or "Substance or composition X for use in the treatment of Y" will be potentially allowable.

* Missed deadlines

Under the old law, if a European patent application was refused or deemed withdrawn following failure to reply to an official letter, the application could be reinstated without a loss of rights by requesting 'further processing', paying a 'further processing fee' and completing the omitted act within the extended time period set by the EPO. However, further processing could only be requested in limited circumstances. In other circumstances, where rights were lost, but it was not possible to request further processing a complex and costly process for re-establishing rights exists, but it was necessary to provide by filing evidence supporting the fact that it was not possible to meet the deadlines despite all due care having been taken.

In contrast, under the new law it will be possible to request further processing in the majority of cases where a deadline has been missed. This will greatly simplify the procedure involved, reduce costs and provide more certainty for applicants.

Other notable changes include the relevance of 'novelty only' prior art documents in the designated states, the requirements for obtaining a valid filing date for a European patent application and the introduction of a post grant central limitation and revocation procedure.
Whilst implementation of the new law will provide many advantages for applicants in the pharmaceutical sector and elsewhere, there is at least one change that will be unfavourable.

* "Multi-invention" applications

It is the established practice in most jurisdictions that a patent may only be granted for a single invention.

Under the old law, if an International patent application entered the European regional phase, and it related to more than one invention, it was possible to choose upon which invention future examination of the application should be based. This situation typically arose in a patent application relating to more than one gene sequence or protein where the EPO considered each gene sequence or protein to relate to a separate invention. The old law provided a convenient way for applicants to file a single patent application covering a large number of gene sequences or proteins and then to decide which gene sequences or proteins were the most important once further experiments had been performed.

Under the new law, if the EPO established the International Search Report (ISR), the resultant European patent application will automatically proceed on the basis of the first invention identified in the claims. If protection is required for other inventions included within the application, then it will be necessary to file one or more divisional applications, which can prove to be a costly exercise.

Accordingly, when preparing International patent applications which are to be examined by the EPO, it is advisable to decide upon the most important subject matter and to prepare the application so that this subject matter is the first subject matter identified in the claims.
If the EPO did not establish the ISR, then it will be possible to amend the claims on entry into the European regional phase to relate to the invention of choice.

Mark Sweetinburgh, a European Patent Attorney from Fry Heath Spence commented "In general, it appears that the changes to the law brought about by EPC2000 will be of benefit to applicants. However, it remains to be seen whether the benefits to those in the pharmaceutical industry will be outweighed by the restrictions imposed during the examination of multi-invention applications."

FDA Grants Tentative Approval to First Generic for Antiretroviral Viread

ROCKVILLE, Md., Dec.18, 2007--The U.S. Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug for use in combination with other antiretroviral agents in the treatment of HIV.

Tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of FDA's manufacturing quality and clinical safety and efficacy requirements.

The action marks the first tentative approval for a nucleotide analog reverse transcriptase inhibitor (nRTI). The nRTIs block an enzyme called reverse transcriptase, which is important to HIV production.

“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem.”

Tenofovir disoproxil fumarate is the latest addition of an anti-retroviral product that can be considered for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion effort to fight the HIV/AIDS pandemic — the largest commitment ever by a single nation toward an international health initiative.

All FDA reviews of applications received in association with the PEPFAR program are expedited. FDA reviewed this application for generic tenofovir disoproxil fumarate tablets in less than six months.

The U.S. Department of Health and Human Services and its agencies, including FDA, are part of an interagency effort under PEPFAR to accomplish the President's goals of treating 2 million HIV-infected people, preventing 7 million new infections, and caring for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children.

As of Sept. 30, 2007, PEPFAR supported life-saving anti-retroviral treatment for a total of more than 1.3 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. On May 30, 2007, President Bush announced that he would work with Congress to reauthorize PEPFAR for another five years.

The tenofovir disoproxil fumarate 300 milligram tablets are manufactured by Matrix Laboratories, LTD, of Andhra Pradesh, India.

Otsuka to acquire busulfan rights from PDL BioPharma

Otsuka Pharmaceutical Co., Ltd. (OPC) and PDL BioPharma, Inc. (PDLI) have entered into a definitive agreement under which Otsuka will acquire from PDL the rights to IV Busulfex (busulfan), including trademarks, patents, intellectual property and related assets, for $200 million, to be paid in cash at closing.

IV Busulfex is an oncologic product marketed and sold by PDL in the United States (US) and Canada, and through distributors in a number of other countries.

"The acquisition of IV Busulfex, a first-in-class drug therapy for conditioning prior to allogeneic haematopoietic progenitor cell transplantation, and the oncology expertise of PDL accelerates Otsuka's global oncology business," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. "We are currently developing first-in-class oncology drugs in the United States, including drugs to treat severe cancer pain (currently in phase II), along with oral mucositis and leukaemia (currently in phase I). Our focus is on global opportunities to contribute to the health of patients who are suffering from severe illness."

"We're pleased to enter into this agreement with Otsuka, which builds on the successful efforts of PDL's commercial team and enables this important product to continue to benefit patients worldwide," said L. Patrick Gage, Ph.D., PDL's interim chief executive officer.

"This transaction is a first step to deliver on our strategic goal to maximize value for our stockholders through our ongoing strategic process."This transaction follows PDL's decision, announced on October 1, 2007, to actively pursue the sale of its key assets. PDL continues with this strategic process, which includes working to maximize the value of its royalty stream, commercial products and antibody discovery, development and manufacturing assets.

Following the close of the transaction, OPC will oversee the outsourced manufacturing of the product, while its U.S. affiliate, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex.

Another OPC affiliate, Otsuka America Pharmaceutical, Inc. (OAPI), will market the product for its current indication in the United States. OPDC was established in 2007 and OAPI was established in 1989 by Otsuka America, Inc. (OAI). Both OPDC and OAPI are wholly owned by OAI, which is the holding company for OPC's interests in the US. OAI is wholly owned by OPC.

The transaction has been approved by the boards of directors of both companies and is expected to close in the first quarter of 2008, subject to antitrust clearance under the Hart-Scott-Rodino Act and satisfaction of other customary conditions.

Montgomery and Co., LLC is acting as financial advisor and Heller Ehrman LLP is acting as legal advisor to OPC in connection with the transaction. Merrill Lynch & Co. is acting as financial advisor and DLA Piper is acting as legal advisor to PDL in connection with the transaction. ]

IV Busulfex was approved by the U.S. Food and Drug Administration (FDA) in 1999 for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic haematopoietic progenitor cell transplantation (also referred as blood or bone marrow transplantation or BMT) for chronic myelogenous leukemia (CML). IV Busulfex is the only drug that is FDA-approved for use in combination with cyclosphosphamide as a conditioning agent in allogeneic haematopoietic stem cell transplantation for CML.

During the 12 months ended September 30, 2007, IV Busulfex sales were $29.4 million, a 29.7 percent increase over the $22.7 million in sales in the prior 12-month period. IV Busulfex is marketed in more than 40 countries worldwide.

Wyeth Submits New Clinical Trial Data on Viviant to FDA

Wyeth has submitted reports on two recently completed clinical studies of its osteoporosis drug Viviant to the FDA in support of two new drug applications (NDAs) for the drug.
The agency sent the company an approvable letter for the drug’s proposed prevention indication, requesting data from a Phase III trial, including information on bone fractures.

The data Wyeth submitted come from two trials conducted in Asia. These data also supplement the company’s pending NDA for Viviant (bazedoxifene) to prevent postmenopausal osteoporosis.

The action date for the prevention NDA is the end of this month, but no labeling discussions have taken place yet, the company said. It added that the agency may issue an action letter by the end of the year or extend the review period by 90 days as a result of the new data submission.

The FDA action date for Wyeth’s separate NDA for Viviant as a treatment for postmenopausal osteoporosis remains the end of May 2008, the company said. — Martin Gidron

Pfizer Moving Ahead With Biotech Acquisitions

Pfizer said it has received U.S. and German antitrust approvals for its $164 million purchase of Coley Pharmaceutical Group and announced separately that it will acquire CovX, a privately held biotherapeutics company, for an undisclosed amount.

Pfizer first announced the acquisition of Coley last month. The publicly held biopharmaceutical company specializes in vaccine adjuvant technology and a new class of immunomodulatory drug candidates designed to fight cancers, autoimmune diseases and allergy and asthma disorders.
Acquiring Coley is part of Pfizer’s strategy to research new vaccines to prevent infectious diseases and treat cancers and other debilitating conditions, Jeffrey Kindler, Pfizer chairman and CEO, said. Areas where the two firms already are cooperating on research include Alzheimer’s disease, asthma, infectious diseases and oncology.

CovX specializes in preclinical oncology and metabolic research and is a developer of a biotherapeutics technology platform that has led to three early-stage compounds — one in diabetes and two in oncology. Pfizer’s acquisition of the firm is expected to close in the first quarter of 2008. — Martin Gidron

Insmed Receives FDA Orphan Drug Designation for Iplex in the Treatment of Myotonic Muscular Dystrophy

RICHMOND, Va., December 18, 2007 /PRNewswire-FirstCall/ -- Insmed Inc. , a developer of follow-on biologics and biopharmaceuticals, today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for Iplex(TM) for the treatment of Myotonic Muscular Dystrophy (MMD). Insmed is currently conducting a 24-week Phase III enabling trial for IPLEX(TM) in MMD, and recently was awarded a grant of approximately $2.1 million from the Muscular Dystrophy Association (MDA), which is expected to cover a substantial portion of the external costs associated with the trial.

"This Orphan Drug Designation is another milestone for Insmed in our development and commercialization plan for IPLEX(TM) in MMD," said Geoffrey Allan Ph.D., Insmed's President and Chief Executive Officer. "Orphan status, combined with the recent $2.1 million MDA grant, positions us well to continue advancing this important product candidate through clinical development, and maximize the market opportunities for MMD available to us."

Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually. This orphan drug designation for IPLEX(TM), grants Insmed seven years of market exclusivity upon approval for the MMD indication. In addition, Insmed is eligible for tax credits relative to its development costs, as well as assistance from the FDA in advancing the drug candidate through the regulatory process.

MMD affects approximately 37,000 Americans, and nearly 60,000 people in the European Union. MMD is a genetic disease characterized by endurance loss, muscle wasting, weakness, pain, cognitive impairment and gastro-intestinal dysfunction. There is currently no cure for the disease, and no specific treatment has been developed to satisfactorily reverse or ameliorate the common symptoms associated with the disease.

Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer

SAN MARINO, Calif., December 18, 2007 /PRNewswire/ -- Epeius Biotechnologies Corporation announced today that the company has received a Certificate of Product Registration for Rexin-G(R) from the Philippine Bureau of Food and Drugs (BFAD), enabling the commercialization of its lead product as a safe and effective treatment for a broad spectrum of intractable cancers. Developed as a tumor-targeted anticancer agent, that actively seeks out and destroys metastatic cancers, Rexin-G exhibits unprecedented single-agent efficacy where other agents, including targeted biologics, have failed. Moreover, Rexin-G has established an exemplary record of clinical safety, virtually eliminating the systemic toxicities routinely encountered with chemotherapies, thus enhancing quality of life.

Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension

NEW YORK, December 18, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Mylan Inc. announced today that the novel beta blocker Bystolic(TM) (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. Hypertension affects approximately 72 million adults in the U.S. and 65 percent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range (blood pressure <140/90 mmHg), underscoring the need for additional therapeutic options.

Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 percent Black, 54 percent male, 19 percent elderly and 8 percent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.
"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."

Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the U.S. and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.

Forest licensed U.S. and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the U.S. and will pay Mylan undisclosed royalty payments as part of their collaboration agreement.

Forest expects Bystolic to be available to physicians, patients, and pharmacies in January 2008.

FDA Approves New Beta Blocker to Treat High Blood Pressure

ROCKVILLE, Md., Dec. 17, 2007-The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for the treatment of high blood pressure.

Bystolic is a beta blocker, a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. It is a new drug not previously approved in the United States.

Nearly one in three adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death.
"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," said Douglas C. Throckmorton, M.D., FDA's deputy director of the Center for Drug Evaluation and Research. "Bystolic offers a new treatment option for people who need to control their high blood pressure."

The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.
A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control. In total, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers.

The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness and diarrhea.

Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., is the sponsor of Bystolic. New York City-based Forest Laboratories, Inc. owns the rights for the sales and marketing of the drug.

Eisai Enters Into In-licensing Agreement Minophagen Pharmaceutical for Liver Disease/Allergic Disease Agents Stronger Neo-Minophagen and Glycyron tab

TOKYO, Dec. 18, 2007--Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) signed an in-licensing agreement with Minophagen Pharmaceutical Co., Ltd. (Headquarters: Tokyo, President and CEO: Kyozo Utsunomiya) for liver disease/allergic disease agents Stronger Neo-Minophagen® C and Glycyron® Tablets on December 18, 2007.

With this agreement, Eisai will assume exclusive rights for development and marketing of these products in Japan and in the Euro-Asia countries and region where the products are yet to be sold.*1 For China and the Euro-Asia countries and region where the products are currently sold*2, Eisai will assume exclusive first negotiation rights, with exclusive marketing rights in China upon termination of the existing agreement between Minophagen Pharmaceutical and its current local marketing partner. The companies expect to transfer the marketing activities to Eisai in China on April 1, 2009. In Japan, transfer of the marketing activities for Stronger Neo-Minophagen® C and Glycyron® Tablets are expected to take place on April 1, 2008 and October 1, 2008, respectively.

It has been reported that about 170 million people in China are affected with viral hepatitis and 70 percent of these cases are hepatitis B, which is treated by antiviral therapy and immunotherapy including interferon or hepato-protector therapy. Currently, Eisai is developing clevudine, an antiviral agent for viral hepatitis B that has been licensed by Bukwang (Korea), and by introducing the two agents announced today to Eisai's product lineup, Eisai can make further contributions to the patients and their families in China.

In Japan, approximately 2.8 million people are estimated to be affected with viral hepatitis, with more than half of this population being afflicted with chronic hepatitis C. Introduced in 1948 and in 1957, Stronger Neo-Minophagen® C and Glycyron® Tablets have been widely used in the treatment for improvement of abnormal hepatic function in chronic hepatitis C, especially when eradication of hepatitis C virus is difficult.

Moreover, the studies conducted in Europe have shown the effectiveness of Stronger Neo-Minophagen® C in improving abnormal hepatic function in patients with chronic hepatitis C where interferon therapy does not work. The results of the studies were presented at the American Association for the Study of Liver Diseases conference in November, 2007.

Eisai has been making efforts for research activities in the hepatic disease area with support from medical specialists in Japan since the 1960's. The results of these efforts have led to the introduction of the PIVKA-II series, a diagnosis product for hepatocellular cancer in 1989, which has been enabling Eisai to address the needs in the area of hepatic diseases. Additionally, Eisai has been focusing on gastrointestinal disorders as one of the strategic areas. In Japan, Eisai markets a proton pump inhibitor Pariet® and gastritis/gastric ulcer treatment Selbex®.
With this agreement, Eisai can enhance its product lineup for the gastrointestinal disorders area that is available in countries in Asia including Japan and China, and thereby make further contributions to increase the benefits to patients and their families.

BioMarin Re-Acquires Rights to Kuvan in Canada From Merck Serono

NOVATO, Calif., December 18, 2007 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. announced today that it has re-acquired the Canadian rights for tetrahydrobiopterin (BH4), including Kuvan(TM) (sapropterin dihydrochloride), from Merck Serono, a division of Merck KGaA, Darmstadt, Germany. Kuvan is an oral small molecule for the treatment of phenylketonuria (PKU) developed in partnership with Merck Serono. Based on published literature, there are approximately 1,200 to 1,500 people under the age of 40 with PKU in Canada

Acquiring rights to Kuvan in Canada allows BioMarin to better coordinate commercialization efforts in the North American market," said Stephen Aselage, Senior Vice President, Global Commercial Development of BioMarin. "This agreement with Merck Serono comes at an exciting time for the company and the PKU community after Kuvan was approved in the United States last week."

The terms of the agreement specify a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed cap.

Endo and Penwest Receive New Paragraph IV Certification Notice From Impax for Opana ER

CHADDS FORD, PA and DANBURY, CT, Dec 17, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that on December 14, 2007, they received a notice from IMPAX Laboratories, Inc. advising of the FDA's acceptance for substantive review, as of November 23, 2007, of IMPAX's Abbreviated New Drug Application (ANDA) containing a new Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. IMPAX stated in its letter that the FDA requested IMPAX to provide notification to Endo and Penwest of this certification. This Paragraph IV certification notice refers to Penwest's U.S. Patent Nos. 7,276,250, 5,958,456 and 5,662,933, which cover the formulation of OPANA(R) ER. These patents are listed in the FDA's Orange Book and expire in 2022, 2013 and 2013, respectively. In addition to these patents, OPANA ER has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009.

Endo and Penwest are currently reviewing the details of this new notice from IMPAX and will continue to pursue all available legal and regulatory avenues in defense of OPANA ER, including enforcement of their intellectual property rights and approved labeling.

Eli Lilly Joins Glaxo, Withdraws Application for Osteoporosis Drug

Eli Lilly & Co. has voluntarily withdrawn its Application No. IN/PCT/00/00118 filed July 05, 2000 at Kolkata Patent Office for a stable crystalline form of osteoporosis drug Teriparatide (rDNA origin), globally marketed as Forteo with worldwide annual sales of US $ 600 million. According to the Patent Office, Lilly has withdrawn its application under section 11B (4) of the Patents Act, 1970. The Application claims earliest priority from US provisional application No. 60/069,875 filed December 18, 1997 against which US Patent No. 6,590,081 is issued on July 08, 2003. Earlier in August 2007, Kolkata Patent Office rejected Lilly’s Application for same drug following a pre-grant opposition from a Mumbai-based generic drug manufacturer USV Ltd. The rejection was made on the grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy. Teriparatide is a parathyroid hormone (PTH (1-34) (SEQ. ID NO:2)), a secreted 84-amino acid product of the mammalian parathyroid gland that controls serum calcium levels through its action on various tissues, including bone. Although not very sure about the Application number which got rejected by the Patent Office, but I guess it would be the Application No. IN/PCT/00/00119 filed July 26, 2000 for stabilized parenteral composition of Teriparatide (rDNA origin) claiming earliest priority from US provisional application No. 60/069,075 filed December 09, 1997 against which Orange Book listed US Patent Nos. 6,770,623 and 7,144,861 are issued. There is one more Application No. IN/PCT/00/00336 filed January 09, 2003 which is pending with the Patent Office which claims earliest priority from US provisional application Nos. 60/097,151 and 60/099, 746 filed November 08, 1998 and October 09, 1998 respectively and against which Orange Book listed US Patent Nos. 6,977,077 and 7,163,684 are issued. The Application IN/PCT/00/00336 seems to cover a method for increasing the toughness and/or stiffness of bone and/or reducing the likelihood and/or severity of bone fracture using Teriparatide, which is unlikely to receive a patent in India, as indication and method of treatment are excluded from patentability under section 3(e) of the Patents Act, 1970. So, most likely either Lilly will too withdraw the third application or it would be humbly rejected by the Patent Office.

Patent experts call for Brazilian model of patenting in India

Patent experts have called for a Brazilian model of patenting in India especially in area of examining the relevance of patent applications, to avoid the apathetic approach towards this issue and to limit the controversies to the least possible levels.

The experts noted that the Brazil model where a group of ministers was dealing with all patent-related matters could be effective in a country like India where over 80,000 patent applications are still pending.

The suggestion came from international expert on intellectual property Prof. Carlos M Correa of University of Buenos Aires and Dr Amit Sengupta of People's Health Movement, at a lecture organized by the Campaign for Access to Essential Medicines and the Medecins Sans Frontiers, here recently.

Dr Correa said that there was a big debate on the relevance of patent applications in India and called for more clarity on discovery and invention. He said some organizations applied for the patent registration with some discovery, but claiming it as an invention.

"There should be a standard classification for discovery and invention. If someone is discovering a particular thing that has existed but was not focused, it should not be considered as an invention," he said.

"Genes need not be a part of invention and the patent should not be allowed for their applications. Besides this, microorganisms, plants, computer programmes, business methods etc. should also not be brought into patent jurisdiction,'' the renowned lawyer said.

"A new device to be patented must reveal a flash of creative genius", he said about the invention. There were plenty of `fake' applications seeking to obtain patent but such products are already patented and owned by some other companies, especially in the pharmaceutical and biotechnological field", he added.

He also revealed that there was also a controversy over the subject of patent, that argued whether the applications for having a patent only with some minor changes in component of a particular medicine with no change in medication, should be allowed or not.

He claimed that the WTO was also taking interests in setting up the patent offices in developing countries just to prevent their right especially in case of generic medicines.

He said that in India, patent law had provided flexibility for the Indian companies especially to the generic makers. He appreciated the role of NGOs in India as well as in some of the other developing countries and said they had done remarkable work. "NGOs are playing a big role in some countries including India to challenge the patent law. In India they have done a history making work by fighting Novartis,'' he said.

Dr Amit Sengupta said that India should follow the Brazilian format where a group of ministers used to disclose the applications and deeply examine them.

GlaxoSmithKline Receives FDA ‘Complete Response’ Letter for Cervical Cancer Vaccine

LONDON, PHILADELPHIA, Dec. 17, 2007-GlaxoSmithKline (NYSE: GSK) announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX

A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.

"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,”said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX®to the U.S.market.”

The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.

To date, CERVARIX® has been approved in 45 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singaporeand the Philippines. Licensing applications have been submitted in more than 27 additional countries including Japan. GSK also submitted CERVARIX®to the World Health Organization (WHO) for prequalification in September 2007.

MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA

MINNEAPOLIS--(BUSINESS WIRE)--Dec 17, 2007 - MGI PHARMA, INC. (Nasdaq:MOGN), a biopharmaceutical company focused in oncology and acute care today announced that the New Drug Application (NDA) for Aquavan(R) (fospropofol disodium) Injection was accepted for filing by the United States Food and Drug Administration (FDA). Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures.

The NDA for Aquavan was submitted to the FDA on September 27, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aquavan Injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by July 26, 2008.

Data from phase 2 and phase 3 trials in patients undergoing colonoscopy, a phase 3 trial in patients undergoing bronchoscopy, and an open label study in patients undergoing a variety of minor surgical procedures form the foundation of the Aquavan NDA. In total, data from 21 clinical studies, including 1,611 subjects are included in the application.
About Aquavan(R) (fospropofol disodium) Injection

Aquavan(R) (fospropofol disodium) Injection, a proprietary water-soluble prodrug of propofol that, after intravenous injection, is rapidly converted by an enzyme (alkaline phosphatase) in the body into propofol, is a product candidate in development for sedation of patients undergoing diagnostic or therapeutic procedures. Aquavan has not been approved for marketing by the U.S. Food and Drug Administration (U.S. FDA) or any other regulatory agencies.

Genzyme Announces FDA Approval of Thyrogen for Use in Thyroid Cancer Ablation

CAMBRIDGE, Mass., December 17, 2007 /PRNewswire-FirstCall/ -- Genzyme Corp. announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Thyrogen(R) (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.

"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."

The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.

"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the U.S.," said clinical investigator Paul Ladenson, M.D., professor and director of endocrinology at The Johns Hopkins University School of Medicine. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."

Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.

Thyrogen Use in Ablation

The new indication allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.

In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements and avoid the symptoms associated with hormone withdrawal.

The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.

Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. It is three times more common in women than in men. Although well-differentiated thyroid cancer is very treatable, ongoing monitoring is important as the disease can recur in up to 30 percent of patients.

IMPAX Announces FDA Acceptance of ANDA for Generic Version of Opana ER

HAYWARD, Calif.--(BUSINESS WIRE)--Dec 17, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER, has been deemed acceptable for filing by the U. S. Food and Drug Administration (FDA) as of November 23, 2007. Despite the acceptance, the Company continues to believe that its ANDA as originally filed met all the requirements for acceptance and thus will continue to pursue its administrative remedies with the FDA to reinstate its original filing date of June 29, 2007.

"We also intend to continue to vigorously defend the ongoing patent litigation as previously announced with Endo and Penwest and look forward to prevailing and bringing this important generic product to market," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer.

US panel rejects Merck's bid to sell cholesterol drug Mevacor as OTC drug

Merck & Co., Inc. said certain US advisory panels urged the US Food and Drug Administration (FDA) to reject Merck's request to sell its cholesterol lowering drug Mevacor over the counter.

Mevacor is a prescription medicine that is approved in the US for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularisation procedures in healthy men and women with average or moderately elevated cholesterol levels.

The joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval of the over-the-counter (OTC) use of Mevacor (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.

"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.

The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.

According to the prescribing information, Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant.

Muscle pain or weakness in patients taking prescription Mevacor could be signs of a serious side effect. The most common adverse events reported with Mevacor 20 mg taken once daily were diarrhoea, flatulence, headache and myalgia.

FDA Sends Wyeth Warning Letter Over Effexor Ad

ROCKVILLE, Md., Dec. 14, 2007-The FDA today posted on its website a warning letter sent to Wyeth Pharmaceuticals Inc. over a professional journal ad for depression drug Effexor XR. The letter and promotional material is attached.
Downloads
Effexor_XR-wl.pdf
Effexor_XRPromo.pdf

Glenmark Received Indian Patent for PDE IV Inhibitors

Mumbai-based Glenmark has lately received an Indian Patent No. 201170 for novel heterocyclic compounds as Phosphodiesterase type IV (PDV IV) inhibitors of the Formula I against the mail-box Application No. 363/MUM/2003 filed April 11, 2003 with the Mumbai Patent Office. Possibly this could be Glenmark’s first drug compound patent to be granted patent protection in India, which already has been granted US Patent No. 7,223,789. According to the ‘789 patent disclosure, the compounds are suggested to have reach through indication over the treatment of variety of allergic and inflammatory diseases including asthma, chronic bronchitis, atopic dermatitis, urticaria, allergic rhinitis, allergic conjunctivitis, vernal conjuctivitis, eosinophilic granuloma, psoriasis, rheumatoid arthritis, septic shock, ulcerative colitis, Crohn's disease, reperfusion injury of the myocardium and reperfusion injury of the brain, chronic glomerulonephritis, endotoxic shock and adult respiratory distress syndrome, particularly for the treatment of asthma or chronic obstructive pulmonary disease (COPD).

Pronova BioPharma and FMC Corporation to Develop New Alginate-Based Capsule Products

LYSAKER, Norway, Dec.14, 2007 - Pronova BioPharma ASA (OSE: PRON) ("Pronova BioPharma" or the "Company") today announces that it has entered into a worldwide licence and development agreement with FMC Corporation (NYSE: FMC) ("FMC") to develop products using a novel capsule technology. The proprietary alginate-based capsule technology is expected to significantly strengthen the product life-cycle management of Pronova BioPharma's products and has the potential for use both with the Company's current active pharmaceutical ingredient ("API"), marketed as Omacor in Europe and Lovaza in the United States, as well as in future products under development.

Under the terms of the agreement, FMC will apply its technology to Pronova BioPharma's products while Pronova BioPharma will be responsible for the clinical development and for securing regulatory approval. Pronova BioPharma plans to initiate clinical trials in early 2009 and launch of the new capsule is anticipated in 2010/2011

FMC's novel proprietary capsule technology uses alginate, a marine plant-derived biopolymer, as the main component in the capsule shell. Alginate is gastro-resistant, providing an enteric release profile that delays release of the drug until passage from the stomach into the intestine. The technology also has the benefit of producing a seamless capsule with a significantly thinner shell wall, thus reducing the size of the capsule by approximately 25%. The enteric release profile and smaller size of capsule are expected to result in increased patient compliance.
Commenting on the announcement, Tomas Settevik, Chief Executive Officer of Pronova BioPharma, said: "The new alginate capsule technology has the potential to deliver significant benefits for patients, as well as creating important patent life-extensions for Omacor/Lovaza and other products under development in our pipeline. We look forward to working with FMC in bringing the new capsule technology to market, which we anticipate taking place by 2010/2011."

Ted Butz, Vice President and General Manager, FMC Specialty Chemicals Group said: "We are delighted to partner with Pronova BioPharma to combine our leading edge oral dose technology with such an important pharmaceutical product franchise."

Forest Laboratories Receives Notification of ANDA Filings for Generic Equivalents of Namenda

NEW YORK, December 13, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , announced today that it has received notification from several companies that they have filed Abbreviated New Drug Applications (ANDA) with Paragraph IV Certifications to obtain approval to market generic equivalents of Namenda, an NMDA receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The Company intends to pursue all appropriate legal action to defend its intellectual property related to Namenda. Namenda is covered by an issued U.S. patent which is set to expire in April 2010. Forest has applied for patent term restoration which, if granted, would extend Namenda's patent protection until September 2013.

Barr Subsidiary Sues Watson and Sandoz for Seasonale Patent Infringement

MONTVALE, N.J., December 14, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc. has filed suits against Watson Pharmaceuticals and against Sandoz, a subsidiary of Novartis for infringement of the patent protecting Duramed's SEASONALE(R) extended-cycle oral contraceptive product. Duramed has initiated patent litigation in the U.S. District Court for the District of New Jersey seeking injunctive relief.

"We will pursue all means to enforce the patent covering our SEASONALE extended-cycle oral contraceptive, which was reissued by the PTO in September," said Bruce L. Downey, Barr's Chairman and CEO. "We believe that Watson's product should be removed from the market, and that the Company is due monetary compensation from Watson. In addition, we intend to protect our intellectual property from potential generic competition by Sandoz while our patent is in force."

In September 2007, the U.S. Patent and Trademark Office (PTO) reissued Duramed's patent, U.S. Patent No. 5,898,032, for SEASONALE. The reissued patent has a new number, RE39861, and the same expiration date of June 23, 2017.

In June 2004, Barr was notified by Watson that it had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Watson's generic product. At that time, the Company did not initiate patent infringement litigation with respect to Watson's ANDA. In September 2006, Watson launched a generic version of SEASONALE following final approval from the U.S. Food & Drug Administration (FDA).

In November 2007, Sandoz notified Duramed that it had filed an ANDA containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Sandoz's generic product.

Watson Confirms Patent Litigation With Barr Related to Seasonale

CORONA, Calif., December 14, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, confirmed today that Duramed Pharmaceuticals, Inc., a wholly owned subsidiary of Barr Pharmaceuticals, Inc., has filed a patent lawsuit against Watson and certain of its subsidiaries related to Quasense(TM) (levonorgestrel/ethinyl estradiol tablets USP), Watson's generic version of Seasonale(R), an extended cycle oral contraceptive. The lawsuit asserts that Watson's Quasense(TM) product infringes Duramed's U.S. Patent 5,895,032 ('032).

We fully intend to continue to market Quasense(TM), our generic version of Seasonale(R) and will defend this case vigorously," commented Paul Bisaro, Watson's President and Chief Executive Officer.

Watson launched its Quasense(TM) product in September 2006 following the U.S. Food and Drug Administration's final approval of its abbreviated new drug application. On September 25, 2007, the U.S. Patent and Trademark Office (PTO) issued to Duramed U.S. Patent No. RE39,861 (the '861 Patent) related to Seasonale(R). On December 13, 2007, Barr filed suit against Watson in the U.S. District Court of New Jersey alleging infringement of the '861 Patent seeking to prevent Watson from further commercializing its Quasense(TM) product.

Roche’s Valganciclovir Patented in India

Chennai Patent Office lately granted an Indian Patent No. 207232 to Hoffman-La-Roche for antiviral drug Valganciclovir against the mail-box Application No. 959/MAS/1995 filed July 27, 1995 under section 5(2) of the Patents Act, 1970. Interestingly, the application claims its earliest priority dated July 28, 1994 (pre-1995) probably making Valganciclovir the first pre-1995 drug compound to be patented in India. Generally, there is an unanimous understanding among the Indian pharma patent practitioners and generic companies that only post-1995 drug molecules are eligible for patent protection in India although it is not explicitly been mentioned anywhere in the Patents Act, 1970. This would, in fact, definitely going to be an interesting case, let see what Indian pharma patent experts has to say about this? Coming back to Great Indian Patent Show, Valganciclovir patent application, like most of the antiviral drug applications was opposed during the pre-grant opposition, this time by the Mumbai-based NGO Lawyers Collective, but surprisingly the Chennai Patent Office decided not giving the opponent an opportunity for hearing and proceeded with the examination and grant of a patent. Lawyers Collective has already expressed their dismay over the issue and is planning moving to the Chennai High Court against the discriminatory decision of the Chennai Patent Office. But the Chennai Patent Office firmly stated that the patent is granted looking at the merits in the application and statutorily the Patent Offices are not bound to hear pre-grant opposition. Although I do want to comment over the whole episode, but I do appreciate the bold initiative taken by the Chennai Patent Office to proceed with the application. I believe it would be better that we should leave such issues to our learned Judges to decide what Patent Offices are supposed or not supposed to do, particularly during pre-grant opposition period

Staff costs of Indian pharma cos go up by 33% in first half of 07-08

Indian pharmaceutical companies are facing a steep rise in staff costs in recent years on account of frequent expansion programmes, rising investments in R&D and mergers and acquisitions. Increasing focus on skilled manpower and spending higher amounts to retain them are also substantially adding to the employee costs.

A Pharmabiz study of 25 leading Indian companies show that the employee costs had gone up by 33 per cent to Rs 1,575 crore during the first half of 2007-08 from Rs 1,185 crore in the same period of last year. Barring three companies, the employee costs moved up between 10 to 250 per cent during the first half. The cost of employees of Dishman Pharma, Dr Reddy's Laboratories (DRL), Biocon and Jubilant Organosys saw a growth of over 40 per cent. Similarly, leading companies like Cadila, Lupin, Aurobindo, Glenmark and Panacea Biotec also incurred significant higher employees cost during the first half.

Multinational companies in India, however, have been cutting costs through implementing VRS. However, Novartis reported a rise of 11 per cent in staff cost, but Wyeth has reduced it by 3.4 per cent. The Indian companies have started expanding aggressively in the international market and they need to invest in manpower for marketing there products as well as for manufacturing purpose. Further, contract manufacturing activity is gaining ground with requirement of more skilled people.

The Pharmabiz study has not included some leading companies like Ranbaxy Labs, Wockhardt, Stride Acrolab, Sterling Biotec and MNC like GSK, Aventis, Pfizer, Abbott, Merck, and AstraZeneca, as their financial year endings are in November- December. The staff cost of these companies have gone up by 14.6 per cent to Rs 791.46 crore for the nine month ended September 2007 as against Rs 690.37 crore in the corresponding period of last year. Stride Arcolab's staff cost increased by 41.1 per cent to Rs 39.08 crore from Rs 27.70 crore in the same period of last year. MNCs like Pfizer has successfully reduced its staff cost by 4.7 per cent during the first nine months of 2007. GSK and Merck pushed there staff cost marginally by 3.4 per cent and 2.2 per cent. Ranbaxy's staff cost increased by 17 per cent to Rs 289crore from Rs 247 crore in the corresponding period of last year.

Abbott sues Glenmark in US court over trandolapril

Glenmark Pharmaceuticals Ltd confirmed that Abbott has filed suit on December 07, 2007 in the US district court of New Jersey, seeking to prevent Glenmark from proceeding with the commercialization of its trandolapril; verapamil hydrochloride products which is currently marketed by Abbott as Tarka.

Glenmark has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of trandolapril; verapamil hydrochloride which included a paragraph IV certification with respect to patent listed by "Abbott" in the FDA "Orange Book." Glenmark believes it is the only applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Abbott's patent, Glenmark will be entitled to a 180 day exclusivity period.

Tarka, extended release oral tablets are indicated for the treatment of hypertension. The product had sales of approximately $100 million in the US market.

With this filing, Glenmark has four first to file positions for various products e.g. ezetimibe, desloratadine, atomoxetine hydrochloride. On successful patent challenges company will have shared exclusivity for the desloratadine and atomoxetine whereas in the case of ezetimibe Glenmark will be the sole Company who will be entitled for the 180 days exclusivity.

Additionally, Glenmark has an on-going shared exclusivity on trileptal (an $800 million product). Having completed two months on the market, Glenmark has garnered a substantial market share to lead the generic pack.

The approval of trileptal offered Glenmark its first 180 day exclusivity in the US market and with this the company now has a portfolio of 21 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.

BioMarin Announces FDA Approval for Kuvan

First Specific Drug Therapy Approved for the Treatment of PKU

NOVATO, Calif., Dec. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). Shipments to the distribution channel will commence tomorrow, and BioMarin will begin promotion of Kuvan immediately.

"The approval of Kuvan represents an important milestone for PKU patients and their families and also for BioMarin. We are extremely pleased to bring this promising treatment option to market in just a little over three years since the IND filing, and we are now ready for an immediate launch," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We would like to thank all the patients, their families and physicians, our corporate partners, the FDA, and BioMarin employees for their hard work and dedication in making Kuvan a reality."

"In clinical trials, Kuvan has been shown to help control blood Phe levels in PKU patients, and I am thrilled that this new therapy is now commercially available to the PKU community," stated Dr. Barbara Burton, Professor of Pediatrics, Northwestern University Feinberg School of Medicine; Director, PKU Clinic at Children's Memorial Hospital; and Clinical Investigator in the Kuvan Phase 2 and Phase 3 trials. "With Kuvan now approved, physicians and patients have, for the first time, a drug therapy option to manage the disease."

Kuvan is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet. To determine if there is a response to Kuvan, the recommended starting dose of Kuvan is 10 mg/kg/day taken once daily for up to a month. If there is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5 to 20 mg/kg/day in patients who respond to Kuvan. Kuvan is developed in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

Court Grants Depomed's Motion for Summary Judgment of Patent Infringement Against IVAX

MENLO PARK, Calif.--(BUSINESS WIRE)--Dec 13, 2007 - Depomed, Inc. (Nasdaq:DEPO), today announced that Judge Charles Breyer of the United States District Court for the Northern District of California has granted Depomed's motion for summary judgment of infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 in the company's patent litigation against IVAX Corporation, and denied all three of IVAX's summary judgment motions.

The impact of the court's rulings is that IVAX's infringement of Depomed's patents has been established as a matter of law, without the need for a trial on that issue. The court ruled against IVAX on IVAX's motions for summary judgment related to the validity and enforceability of the patents, and the lack of willful infringement on the part of IVAX.

The court also rejected an interpretation of a disputed patent term proposed by IVAX in support of its invalidity arguments, and instead affirmed Depomed's interpretation of the disputed patent term.

The court has not yet set a trial date for the case.

Carl Pelzel, Depomed's president and chief executive officer, commented, "We are very pleased with the court's ruling, which we believe has significantly strengthened our case going to trial."
In January 2006, Depomed sued IVAX for infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 by IVAX's extended release metformin hydrochloride tablets. The patents are held by Depomed and relate to the company's AcuForm(TM) drug delivery technology.

Depomed is represented by Michael Plimack of Heller Ehrman LLP.

Delhi Patent Office Turn Down Gefitinib Patent Application

Following pre-grant opposition hearing by Indian drug companies Natco Pharma Ltd. and JM Pharmaceuticals Ltd. made last year, the Delhi Patent Office lately rejected AstraZeneca’s Patent Application No. 841/DEL/1996 for its anticancer drug Gefitinib on the ground of “known prior use.” Both Natco and JM opposed the patent application citing that the drug has been in the public domain before the patent application filed in India. Natco spokesperson and company secretary Adi Narayana said his company filed a pre-grant opposition since the drug was not a new drug under the Patents Act, 1970 and lack inventive step. Gefitinib, worldwide marketed as Iressa, is oral tablet medication approved by the US Food and Drug Administration having three Orange Book listed US Patent Nos. 5,457,105 (genus); 5,616,582 (indication) and 5,770,599 (species). The ‘841 patent is Indian equivalent of the species patent.

Wyeth Settles With J&J Unit Over Effexor Patent

Johnson & Johnson unit Alza Corp. and rival pharmaceutical company Wyeth have settled a patent dispute over a drug-delivery system used in Wyeth’s popular antidepressant Effexor.

The parties asked Judge Ron Clark, of the U.S. District Court for the Eastern District of Texas, to dismiss the case with prejudice on Tuesday. The judge granted their request on Wednesday.
In the complaint, which was filed on July 26, 2006, Alza accused Wyeth of willfully infringing its patent covering controlled-release dosage technology for Effexor’s specific chemical compound. The technology allows a drug like Effexor to be released steadily into a user’s bloodstream.
Effexor has been a source of both revenue and legal action for Wyeth. During the first quarter of 2007, Wyeth sold about $891 million worth of Effexor. In both 2006 and 2005, Effexor accounted for 18% of Wyeth's net revenue, according to Wyeth's 2006 financial report.

Alza alleged that Wyeth knew and intended that users of Effexor would use the product in ways that infringed the dosage technology patent.

The patent in the case i.e. U.S. Patent No. 6,440,457., titled “Method of administering antidepressant dosage form,” assigned to Alza, was issued in August 2002 . It expires in August 2019.

Alza sought treble damages and attorneys’ fees.

Wyeth has been to court multiple times to protect its patents for venlafaxine, the active ingredient in Effexor. The patents were granted to Wyeth in 2001 and 2002.

In July, the company sued Mylan Pharmaceuticals Inc., after receiving a letter from Mylan giving notice that it had filed an abbreviated new drug application with the U.S. Food and Drug Administration to market a generic version of the drug.

Wyeth now wants the court to declare that the filing of the ANDA was an act of infringement with respect to each asserted patent and that the commercial manufacture, sale or importation of Mylan's venlafaxine hydrochloride extended-release capsules would infringe the patents.
Wyeth's complaint also asked that the effective date of any FDA approval not come before the expiration of each of the three patents and that the court enjoin Mylan from seeking approval of the ANDA in dispute, or making, selling or importing its proposed venlafaxine product until all three patents have expired.

Wyeth already filed similar lawsuits against several other generic drug makers, including Lupin Ltd., Anchen Pharmaceuticals, Osmotica Pharmaceutial Corp. and Impax Laboratories.
In 2005, it settled a lawsuit with Israeli generic drug company Teva Pharmaceuticals, which had also filed an ANDA to sell a generic version of Effexor.

The case is Alza Corp. v. Wyeth and Wyeth Pharmaceuticals Inc., case number 9:06-cv-00156, in the U.S. District Court for the Eastern District of Texas, in Lufkin.

Roche files IND with US FDA for Genmab's antibody

Genmab A/S said Roche filed an Investigational New Drug application (IND) with the FDA for Genmab's antibody developed under the company's collaboration with Roche.

Genentech and Roche are collaborating on development of the antibody which selectively blocks the interaction of the OX40 ligand and its receptor. The companies are evaluating the antibody for the treatment of asthma. Genmab will receive a milestone payment from Roche which does not influence Genmab's financial guidance for 2007.

In pre-clinical data published in a recent article and commentary in The Journal of Clinical Investigation, treatment with the human OX40L blocking antibody led to significant therapeutic effects in a nonhuman primate model of allergic inflammation. The mechanisms of action of the human antibody include effective blockade of OX40L binding to its receptor, and depletion of cells expressing OX40L. Depletion of OX40L-expressing cells was shown to depend on interaction of immune effector cells with the therapeutic antibody. The observed in vivo efficacy of the OX40L-specific antibody may also involve restoration of peripheral tolerance mechanisms. Breaking of tolerance promotes development of autoimmune and allergic diseases.

Under the agreement with Roche, Genmab utilizes its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. In certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche.

"Four of the antibodies developed by Genmab under our collaboration with Roche have now entered the clinic. We believe this achievement is a testament to the skill of Genmab's pre-clinical development team who work carefully to select the best product candidates and Roche's dedicated focus on progressing them to market," said Lisa N. Drakeman, Ph.D., chief executive officer, Genmab

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

ROCKVILLE, Md., Dec. 12, 2007--The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."

The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.

The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.

The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.

To screen for this genetic marker, a patient's blood can be drawn by a health care provider and the test administered at a laboratory. It is estimated that about 5 percent of patients being considered for treatment with carbamazepine are of Asian ancestry and would need to have this test.

Studies have found a strong association between certain serious skin reactions and an inherited variant of a gene, HLA-B* 1502, an immune system gene, found almost exclusively in people with Asian ancestry. Patients testing positive for this gene should not be treated with carbamazepine unless the benefit clearly outweighs the increased risk of these serious skin reactions.

Patients who have taken carbamazepine for more than a few months and not experienced any skin reactions are unlikely to ever experience these reactions, regardless of ancestry or genetic test results. Patients currently taking carbamazepine who are concerned about these skin reactions should not stop taking the drug without first consulting their health care provider.

Carbatrol is manufactured by Shire Pharmaceuticals, Wayne, Penn.; Equetro is manufactured by Validus Pharmaceuticals Inc., Parsippany, N.J.; and Tegretol is manufactured by Novartis, East Hanover, N.J. Generic versions of carbamazepine are available

Mylan Announces Tentative FDA Approval for Lamotrigine Tablets

PITTSBURGH, December 12, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets, 25 mg, 100 mg, 150 mg and 200 mg.

Lamotrigine Tablets are the generic version of GlaxoSmithKline's Lamictal(R) Tablets, which had U.S. sales of approximately $1.97 million for the 12 months ending Sept. 30, 2007.

AstraZeneca Files Patent Infringement Actions in Response to Crestor ANDAs

LONDON, Dec. 12, 2007-AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™ (Rosuvastatin Tablets)

On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.

Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.

Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.

Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the ‘314 patent). AstraZeneca licenses the ‘314 patent from Shionogi & Co. Ltd.

Lannett Receives FDA Approval for Phentermine

PHILADELPHIA--(BUSINESS WIRE)--Dec 12, 2007 - Lannett Company, Inc. (Amex:LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the company's supplemental Abbreviated New Drug Application (ANDA) of Phentermine Hydrochloride Capsules 30 mg. The company expects to commence marketing this product immediately.

Phentermine Hydrochloride (HCl) is indicated for the short-term management of obesity. According to Wolters Kluwer, sales of generic Phentermine HCI Capsules exceeded $37 million for the 12 months ended October 2007.

"This approval complements our Phentermine HCI Tablet 37.5 mg which is the generic equivalent of Adipex-P(R), marketed by Gate Pharmaceuticals, a division of Teva Pharmaceutical Industries, and is an important addition to our product portfolio," said Arthur Bedrosian, president and chief executive officer of Lannett. "Through the hard work and dedication of our research and development team, we continue to build a robust pipeline despite a tremendous backlog of product applications pending at the FDA."

Teva Announces Approval of Generic Trileptal Tablets

JERUSALEM--(BUSINESS WIRE)--Dec 12, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' antiepileptic therapy Trileptal(R) (Oxcarbazepine) Tablets, 150 mg, 300 mg and 600 mg. Shipment of the product will begin in the near future.

The brand product had annual sales of approximately $690 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

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

Pfizer Patented First Antiretroviral Compound in India

Mumbai Patent Office lately granted an Indian Patent No. 204132 (the ‘132 patent) to Pfizer for newly approved antiretroviral drug Selzentry, a second-line treatment for HIV, often prescribed to patients who develop resistance to first-line drug therapies. The ‘132 patent is issued against the mail-box Application No. 884/BOM/1999 filed December 02, 1999 under section 5(2) of the Patents Act, 1970 claiming earliest priority from Great Britain applications dated October 23, 1998. Selzentry, worldwide marketed as Maraviroc is the first antiretroviral drug compound to be awarded patent protection in India, which obviously will cause a concern among the generic pharmaceutical companies in India and also the Non-profit Government Organizations advocating affordable drugs for poor patients. Not only Pfizer will be able to keep generic competitors out of the market, but also fueled its market share value on the Bombay Stock Exchange, which clearly indicates the building confidence of Indian market for patent portfolio. Earlier this year in August, the US Food and Drug Administration approved Selzentry oral tablet prescription for the treatment of patients infected with CCR5-TROPIC HIV-1 through an accelerated regulatory approval process, and subsequently listed two US patents with the Orange Book. US Patent No. 6,586,430 is the US equivalent of the ‘132 patent. Although patent is granted in India, Pfizer still need to overcome the post-grant opposition period under section 25(2) of the Patents Act, 1970 which will be valid till one year from the date of grant of patent to have the real taste of Indian market exclusivity. However, there were no pre-grant oppositions for Pfizer’s patent application because Indian generic industry did not find any (financial) market potential for this newly approved drug (which still need to achieve market acceptability and monetary success), which in fact a clear indication that Indian Generic companies are more concern about the profit margins rather than patients’ well-being in India or other least-developed countries, and even so the NGOs who keep targeting patent applications which cover drugs already achieved market success. Despite Selzentry is a critical drug therapy, NGOs and Indian Generics completely failed to spot Pfizer’s patent application for pre-grant opposition because they keep focusing around blockbuster and profitable drug products, which again raises a crucial question who come first profit or patient

Pfizer Wins Dismissal of Ranbaxy's Counterclaims in Caduet Patent Litigation

Pfizer v. Ranbaxy, No. 07-138 (D. Del. 2007)

Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The '893 patent claims atorvastatin calcium, which is also the active ingredient in Lipitor; the '574 patent claims combinations of atorvastatin sodium and amlodipine besylate. Ranbaxy filed counterclaims seeking declaratory judgments that (1) the '893 patent is invalid; (2) the '574 patent is invalid and not infringed; and (3) a third patent, U.S. Patent No. 5,273,995, is invalid, unenforceable and not infringed. In an opinion filed November 29, the district court granted Pfizer's motions to dismiss Ranbaxy's counterclaims on the '893 and '995 patents, leaving only the '574 patent in the case.

On August 2, 2006, the Federal Circuit affirmed the validity of the '893 patent in Pfizer's case against Ranbaxy concerning Ranbaxy's ANDA for a generic version of Lipitor. Ranbaxy appealed to the Supreme Court, and in April, the Court denied Ranbaxy's cert petition. Accordingly, in the Caduet litigation, Pfizer moved to dismiss Ranbaxy's counterclaims of invalidity of the '893 patent on grounds of res judicata. In addition, Pfizer moved for partial summary judgment on the pleadings, asking for a judgment of infringement of the '893 patent on grounds of collateral estoppel.

In opposition to Pfizer's motion, Ranbaxy argued that res judicata principles should be narrowly applied because the issue of obviousness was not presented at trial or adjudicated in the Lipitor litigation, and "significant factual and legal changes have occurred since the Lipitor litigation that fundamentally alter the obviousness analysis of the '893 patent." Specifically, Ranbaxy argued that the Supreme Court's decision in KSR v. Teleflex "dramatically lowered the bar of 35 USC 103." The district court, however, was unconvinced, stating that Ranbaxy challenged the validity of the '893 patent in the Lipitor litigation, and therefore, absent fraud or a momentous legal change in constitutional rights, "Ranbaxy was required to raise all of its invalidity defenses at that time." Thus, the court granted Pfizer's motion to dismiss. In addition, because Ranbaxy did not contest infringement of the '893 patent, the court granted Pfizer's motion for a judgment of infringement of the '893 patent on the pleadings.

In the same August 2, 2006 decision, the Federal Circuit held that Claim 6 of the '995 patent is invalid. The '995 patent covers pharmaceutical compositions containing atorvastatin calcium. Pfizer is currently seeking a reissue of the '995 patent to correct the defect in Claim 6 and to correct defects in other claims. In the Caduet litigation, Pfizer moved to dismiss Ranbaxy's counterclaims on the '995 patent on grounds that it has provided Ranbaxy a covenant not sue Ranbaxy on all remaining claims of the original '995 patent.

In response to this motion, Ranbaxy argued that its declaratory judgment counterclaims of unenforceability of the '995 patent should not be dismissed, notwithstanding Pfizer's covenant not to sue, because "Pfizer has not agreed to provide Ranbaxy with a covenant not to sue related to any reissue of the '995 patent." Here too, however, the district court was unconvinced by Ranbaxy's arguments. The court stated: "the question of whether a new patent will ever be reissued is speculative, purely hypothetical and unripe for judicial determination. Accordingly, the Court concludes that these circumstances do not support jurisdiction under the MedImmune standard."

As a result of the district court's decision, Ranbaxy will not be able to launch its generic version of Caduet until at least 2010, when the '893 patent expires. Pfizer will now proceed with the case, aiming to keep Ranbaxy off the market until 2018, when the '574 patent expires.

Perrigo to Launch Generic Prilosec OTC

After settling with AstraZeneca last month, Dexcel Pharma Technologies has received final FDA approval for generic Prilosec OTC.

The company’s marketing partner Perrigo plans to launch the product early next year.
Perrigo’s announcement came the same day the FDA confirmed there is no evidence of an increased risk of heart problems with Prilosec (omeprazole) or AstraZeneca’s other heartburn drug, Nexium (esomeprazole magnesium) (DID, Dec. 11).

AstraZeneca sued Dexcel in May 2006 after the company submitted an abbreviated new drug application with Paragraph IV certifications for Prilosec OTC (omeprazole magnesium). As part of the settlement, the companies agreed that Dexcel could market its product as soon as it received final approval (DID, Nov. 5). Other terms of the settlement were not disclosed.

Perrigo Chairman and CEO Joseph Papa said the Prilosec OTC launch during the first quarter of 2008 will likely be the largest in the company’s 120-year history.

Prilosec OTC has estimated annual sales of approximately $750 million, according to Perrigo. The company said it expects itsgeneric product to achieve annual sales of $150 million to $200 million.

Perrigo also raised its fiscal 2008 earnings guidance. Generic Prilosec OTC is expected to contribute between 20 cents and 25 cents earnings per share, resulting in earnings of approximately $1.32 to $1.47 per share.

Prilosec OTC, the first OTC proton-pump inhibitor, is a once-a-day, delayed-release tablet formulation that was approved in 2003.

Novo Nordisk Settles With Pfizer On Patent Infringement Suit

PRINCETON, N.J., December 10, 2007 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. today announced the company has settled a lawsuit against Pfizer claiming that Pfizer's product Exubera(R) infringed patents owned by Novo Nordisk. The patents cover inhaled insulin treatment for diabetes.

The lawsuit was originally filed in August 2006 in United States Federal Court in the Southern District of New York.

The five patents involved in the suit were U.S. Patent Numbers 5,884,620; 7028,686; 6167,880; 5,941,240 and 5,672,581.

In the patent suit, a federal judge denied a Novo Nordisk bid to barr Pfizer's sales of Exubera in December 2006, tossing a request for an injunction. U.S. District Judge Leonard B. Sands held that the public interest weighed in favor of denying the injunction, noting Pfizer's argument that Exubera offered diabetics who were not coping well with their disease or were afraid to inject insulin, a new, needle-free way to deal with their disease.

In October, however, Pfizer announced that it would no longer be making the diabetes treatment available because it has failed to gain the acceptance of patients and physicians.
That announcement came as a surprise to Pfizer's partner Nektar Therapeutics, which immediately responded by saying it had not been pleased with Pfizer's performance in marketing the diabetes drug.

Pfizer later agreed to pay Nektar Therapeutics $135 million in order to bow out of a marketing agreement the two companies had over Exubera. As part of that deal, Pfizer also agreed to hand over any remaining rights to the inhaled insulin treatment, including an number of regulatory filings and applications and the continuation of ongoing Exubera clinical trials, in the event that Nektar found another partner to market the diabetes drug.

That agreement also resolved contractual issues related to the development of an updated version of Exubera, which the companies said was currently in Phase 1 clinical development.

Nicholas Piramal secures patent for cancer compounds

Nicholas Piramal India Ltd has announced that the US Patent and trademark office has granted product patent to the company. The granted claims of the patent cover the novel compounds, including the company's clinical candidate P-276-00, and processes for their preparation. These compounds are being developed as therapeutic agents useful in the treatment of cancer.

Earlier the company has been granted a patent in South Africa for its CDK inhibitors. The company has related national phase applications in 14 other countries. The company has filed five other patent applications covering different aspects of its CDK inhibitors.

Dr Noopur Raje from Dr Ken Anderson group from Dana Faber Cancer Institute is giving an oral presentation at 49th Annual Meeting and Exposition of American Society of Haematology (ASH) being held at Atlanta, Georgia in US from December 8-10, 2007. They have carried out independent studies on the company's lead compound P-276-00 in Multiple Myeloma and will be presenting new data on its pre-clinical studies.

The ASH annual meeting is the premier forum for physicians and researchers to hear the most up-to-date developments in Haematology. The event attracts over 16,000 Haematologists and other health-care professionals from 100 countries around the world.

Dr Swati Piramal, director strategic alliances and communications of the company said, "The presentation of data on pre-clinical studies at annual conference of American Society of Haematology marks an important milestone for development of NPIL's Oncology compound".

Watson, Novartis settle Exelon lawsuit

Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, said it has reached a settlement with Novartis on outstanding patent litigation related to Watson's generic version of Exelon (rivastigmine tartrate) capsules.

Under the terms of the settlement agreement, Novartis has granted Watson a license to its US patents covering Exelon for a generic version of Exelon. The agreement generally provides that Watson will not commence marketing its generic equivalent product until sometime prior to the expiration of the patents covering Exelon.

The specific date on which Watson may launch its generic product and other details concerning the settlement have not been disclosed. Watson's Abbreviated New Drug Application for its generic version of Exelon has been tentatively approved by the US Food and Drug Administration.

Provectus Pharmaceuticals Receives Patent in India for Lead Oncology Product

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Dec 11, 2007 - Provectus Pharmaceuticals, Inc. (OTCBB:PVCT) (http://www.pvct.com) has received a patent in India protecting its lead oncology agent, PV-10, along with a number of related agents. The patent covers injectable and other forms of the drugs, including capsules, tablets, and oral suspensions and solutions. A range of active compounds are protected, each related to the active ingredient in PV-10.

"Obtaining patent protection in India for PV-10 and our additional pipeline products is a major milestone, assuring a viable route to access a market representing roughly one-fifth of the world's population," noted Craig Dees, Ph.D., CEO of Provectus. "Additionally, as the Indian pharmaceutical industry becomes a larger player in the worldwide market, this protection establishes an important right of ownership for products sold or made in India."

Dees Continued: "The Company is seeking protection of its assets in key markets worldwide, and this patent further validates the value of our science and our global intellectual property strategy to build value for our shareholders. As we focus on clinical development of our lead therapeutic products, PV-10 for cancer and PH-10 for dermatology, we believe that aggressively protecting the intellectual assets underlying our technologies will be vital to our eventual marketing success."

Enantiomer Exclusivity Revisited - The Food and Drug Administration Amendments Act of 2007

Tucked away at the end of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is a provision that modifies FDA?s long-standing refusal to award five-year new chemical entity (NCE) exclusivity to enantiomers of previously-approved racemic mixtures. Pub. L. No. 110-85, __ Stat. __ (2007); FDAAA § 1113.

The Food and Drug Administration (FDA) has the authority under the Hatch Waxman Act to grant five years of exclusivity to drugs that contain new chemical entities, referred to as NCE exclusivity in the Orange Book, but up until this legislation FDA had declined to grant NCE exclusivity to enantiomers that were part of previously-approved racemic mixtures. See Federal Food Drug and Cosmetic Act (FDCA) §§ 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii). According to FDA, exclusivity was not justified because the enantiomer had been previously approved ? albeit as part of a racemic mixture. See 54 Fed. Reg. 28872 at 28898 (July 10, 1989).

In an effort to encourage the continued development of these important chemical species, the FDAAA has modified FDA?s policy with the addition of a new subsection (u) to section 505 of the FDCA, so that FDA can award NCE exclusivity to enantiomers under limited circumstances. However, to ensure that the exclusivity fosters significant medical innovation and does not become simply another tool for life cycle management, the legislation limits the award of exclusivity to particular circumstances.


Life cycle management was clearly a concern to Congress in granting this exclusivity, and the legislation contains several limitations that ensure exclusivity is only awarded in cases of significant medical innovation. For example, exclusivity is only available for new drug applications that do not rely on studies for a previously approved racemic mixture. FDCA § 505(u)(1)(A), as amended by FDAAA 1113. Exclusivity is also only available if the enantiomer is approved in a different therapeutic category than the racemic mixture. FDCA § 505(u)(1)(B), as amended by FDAAA 1113. Conversely, FDA will not approve the enantiomer for use in the same therapeutic category as the racemic mixture for ten years from the enantiomer?s approval date. FDCA § 505(u)(2)(A), as amended by FDAAA 1113.

Unless the legislation is reauthorized, the exclusivity is only available for new drug applications filed before October 1, 2012. FDCA § 505(u)(4), as amended by FDAAA 1113

Pfizer sues Cobalt over lipitor patent (contd.......)

Pfizer Inc. is alleging that when Cobalt Pharmaceuticals Inc. filed a New Drug Application for a product whose active ingredient would be atorvastatin sodium, the Canadian generics outfit infringed a patent covering the blockbuster cholesterol drug Litpitor.

Pfizer and a group of subsidiaries including Warner Lambert Co. filed a suit against Cobalt on Friday in federal court in Boston. The suit accused Cobalt of infringing a patent owned by Warner Lambert.

The same plaintiffs filed a suit against Cobalt in Delaware on Thursday. That suit accused Cobalt of infringing the same patent and referenced the same NDA. A Pfizer representative would not comment Monday on why the infringement claims were filed in different jurisdictions.

At issue is U.S. Patent Number 5,273,995, which was issued in 1993, is owned by Warner Lambert and covers Lipitor, the complaint said. Lipitor, a formulation of atorvastatin calcium, brought in $3.2 billion in worldwide revenues for Pfizer in the third quarter of 2007, according to a Pfizer press release dated Oct. 18.

Pfizer received a letter from Cobalt, dated Oct. 24, 2007, alerting Pfizer that Cobalt had filed NDA No. 22-245 asking for the U.S. Food and Drug Administration's approval to make and sell a product containing atorvastatin sodium as its active ingredient before the expiration of the '995 patent, the complaint said.

The expiration date on the '955 patent in Dec. 28, 2010, but Lipitor was granted an extension of exclusivity through June 28, 2011, Pfizer said.

Cobalt infringed the patent by submitting its NDA, Pfizer claimed

Claim 6 of the '995 patent was declared invalid by the U.S. Court of Appeals for the Federal Circuit in August 2006, but the complaint does not seek relief based on that claim, Pfizer said.
Indian generic drug maker Ranbaxy Laboratories Ltd. brought the appeal that led to claim 6's invalidation, following a December 2005 defeat in federal court in Delaware. Pfizer said it plans to rectify the flaw in the ‘995 patent through the U.S. Patent and Trademark Office.

The Federal Circuit's August ruling upheld U.S. Patent Number 4,681,893, which covers atorvastatin, Lipitor’s active ingredient.

The Federal Circuit deemed claim 6 of U.S. Patent Number 5,273,995 invalid because it failed to comply with the requirements of 35 U.S.C. Section 112, paragraph 4, which deals with dependent claims.

That paragraph specifically says that a dependent claim shall “specify a further limitation of the subject matter claimed.”

The Federal Circuit referenced the district court’s reluctance to declare the ‘995 patent — which deals with the calcium salt of atorvastatin — invalid. Although the lower court recognized that “there may be a technical problem in the drafting of claim 6,” it didn’t see that flaw as adequate grounds for a declaration of invalidity.

But the Federal Circuit disagreed, swayed by Ranbaxy’s argument that the claim failed to properly specify limits to the subject matter it refers to.

Pfizer wants a judgment from the Boston court holding that the effective date of any FDA approval for NDA 22-245 can't be earlier than June 28, 2011; a permanent injunction barring from making, selling or importing the product contemplated in the NDA; and attorneys' fees and costs.

A Cobalt representative could not be immediately reached to discuss the lawsuits.

In the Boston action, Pfizer is represented by Cesari & McKenna LLP. Connolly Bove Lodge & Hutz LLP is of counsel.

The case is Pfizer et al. v. Cobalt Pharmaceuticals Inc., case number 07-12257 in the U.S. District Court for the District of Massachusetts.

The Delware case is Pfizer Inc. et al v. Cobalt Pharmaceuticals, Inc. case number 07-790 in the U.S. District Court for the District of Delaware.

Remarks: This will give good detail about the case filed against Cobalt. I hope this will be useful. Enjoy................

Pfizer Sues Canadian Drug Company (Cobalt) Alleging Lipitor Patent Infringement

Pfizer Inc., the world's largest drugmaker, sued Canadian generic-drug company Cobalt Pharmaceuticals Inc. alleging infringement of a U.S. patent for Lipitor, a medicine used to lower cholesterol. "Pfizer will be irreparably harmed" if a judge doesn't stop Cobalt's infringement, Pfizer said in the suit filed yesterday in Delaware.

The company also seeks legal fees and expenses. Lipitor, the world's best-selling drug, logged US$9.2-billion in sales in the first nine months of 2007, or 26% of New York-based Pfizer's revenue. In the lawsuit, Pfizer asked a judge to stop Cobalt from selling a copy until the patent expires in June, 2011.

Remarks: This is the preliminary information available with me. As soon as I will get the detailed information I will update my blog w.r.t this topic.

Amgen gets marketing nod from EC for cancer drug Vectibix

Amgen said the European Commission has granted a conditional marketing authorization to market its colorectal cancer treatment drug Vectibix.

EU approved Vectibix (panitumumab) as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFr) expressing metastatic colorectal cancer (mCRC) with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens.

Vectibix, a fully human anti-EGFr monoclonal antibody, has been granted a positive Commission decision in the European Union (EU) based upon a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for marketing authorization in September of this year. This approval is based on a positive benefit / risk assessment in a patient population that currently has few treatment options available to them. As part of the CHMP review, clinical data supporting the utility of KRAS mutation status as a biomarker for clinical outcome were provided.

"It is an exciting time in the oncology arena as we see a shift towards individualized patient care," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "We are pleased that Vectibix has received conditional marketing authorization allowing metastatic colorectal cancer patients to have access to a new targeted treatment option.

"These biomarker data were generated from a prospectively defined analysis of the phase III, randomised, controlled clinical trial "408" that investigated the treatment effect of KRAS status (non-mutated versus mutated) in Vectibix patients with mCRC. The analysis demonstrated that the effect of Vectibix on progression-free survival (PFS) was confined exclusively to the approximately 60 percent of patients whose tumours harbour normal, non-mutated (wild-type) KRAS. Vectibix had no clinical benefit in patients who had tumours with mutations in KRAS regardless of the endpoint studied. Previously reported pivotal results from "408" demonstrated that Vectibix monotherapy significantly improved PFS and response rates in heavily pre-treated patients with mCRC after failure of standard chemotherapy versus best supportive care.

KRAS plays an important role in cell growth regulation and oncogenesis. Anti-EGFr therapies work by blocking the activation of EGFr, thereby inhibiting downstream events that lead to malignant signalling. However, in patients with tumours harbouring a mutated or activated KRAS, the KRAS protein is always turned "on" regardless of whether EGFr has been activated or therapeutically inhibited. Thus, in patients with mutated KRAS, signalling continues despite anti-EGFr therapy. Mutant KRAS is detected in approximately 40 percent of CRC tumours.

"Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of metastatic colorectal cancer," said Professor Eric Van Cutsem, Digestive Oncology Unit, University Hospital, Leuven, Belgium, a Vectibix investigator. "The ability to predict the patient population more likely to respond to Vectibix could potentially reduce drug exposure in patients who we know will not respond."

FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events

ROCKVILLE, Md., Dec. 10, 2007-Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium. The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD. Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment. On Aug. 9, 2007 FDA released an "Early Communication of an Ongoing Safety Review" of these drugs. The agency’s initial review determined that there was no increased risk of heart problems associated with long-term use of these drugs. At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern. The following represents the agency’s current analysis of available data on these medications.

Current Information: FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

U.S. FDA Issues Approvable Letter for Requip XL Extended Release Tablets

LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (FDA) has issued an approvable letter for GlaxoSmithKline's (NYSE:GSK) Requip(R) XL(TM) Extended Release tablets. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S.marketing approval.

Requip(R) XL(TM) is a once-daily oral dopamine agonist developed for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The new Requip(R) XL(TM) formulation uses SkyePharma's patented GEOMATRIX(TM) technology and is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.
Requip(R) XL(TM) is approved in eight countries in Europe and a mutual recognition procedure was successfully completed on 27 November 2007, in 17 additional European countries. This step should result in approval of Requip(R) XL(TM) and launches in these countries from the first quarter of 2008 onwards.

Eisai to Acquire MGI Pharmafor $41 Per Share in an All Cash Transaction

TOKYO & BLOOMINGTON, Minn.--(BUSINESS WIRE)--Dec 10, 2007 - Eisai Co., Ltd. (TSE: 4523.JP) ("Eisai"), a research-based human health care (hhc) company that focuses on neurology, gastrointestinal disorders, oncology and critical care, and MGI PHARMA, Inc. (NASDAQ: MOGN) ("MGI PHARMA"), an oncology and acute care focused biopharmaceutical company, today announced that they have entered into a definitive merger agreement under which Eisai would acquire all of the outstanding shares of MGI PHARMA for US$41.00 per share in an all cash transaction, for a total consideration of approximately $3.9 billion.

The merger agreement has been unanimously approved by the MGI PHARMA Board of Directors. The acquisition is expected to occur by means of a tender offer followed by a cash merger, is subject to customary closing conditions and regulatory approvals, and is expected to be completed during the first quarter of 2008.

Eisai expects MGI PHARMA's marketed and pipeline products in oncology and acute care, as well as its R&D and commercial capabilities, including field sales specialists, together with Eisai's existing oncology products, global infrastructure and R&D capabilities, will create a base for continued sales growth, pipeline enhancement and the opportunity for synergies. Eisai expects that this transaction will enable it to grow further in the U.S. market and strengthen its already-focused oncology business platform. Following the completion of the transaction, Eisai anticipates that the transaction will be accretive to its cash EPS (excluding goodwill amortization) in fiscal year 2008 and GAAP EPS in fiscal 2009.

"The Board of Directors of MGI PHARMA, working with our legal and financial advisors, has been reviewing strategic alternatives for the company for the past several months," said Mr. Lonnie Moulder, President and CEO of MGI PHARMA. "During that time, we have had the opportunity to share the MGI PHARMA vision and business opportunity with many of the leading companies in the pharmaceutical and biotechnology industry. This transaction represents the successful conclusion of that process. Our Board of Directors and the management team are extremely pleased to announce this transaction and the opportunity to continue to bring important therapies to patients."

Mr. Haruo Naito, President and CEO of Eisai, said, "Eisai has enormous respect for MGI PHARMA's products, pipeline and people, and we look forward to working with their highly skilled team to address the unmet medical needs of patients throughout the world. Strategically, we expect this transaction to allow Eisai to significantly strengthen its oncology business and increase the likelihood of achieving our current strategic plan targets and our future revenue and earnings growth."

Essilor acquires prescription labs in UK & US

Monday, December 10, 2007 16:00 IST Charenton-le-Pont, France

Essilor has strengthened its prescription laboratory network in Europe with the acquisition of majority stakes in Sinclair Optical Services and United Optical, two independent laboratories in the United Kingdom. The company has also acquired Premier Optics, Inc., Gold Optical Enterprises, Inc. and GK Optical in the United States.

Based in Gloucester, England, Sinclair Optical serves the entire English market with a broad array of products that includes stock lenses, prescription lenses and surface treatments. Its full-year sales amount to €8 million.United Optical is located in Belfast, North Ireland. It also operates a subsidiary in Athlone, Ireland that specializes in the edging and mounting of prescription safety lenses.

United Optical generates full-year revenue of around €5.8 million.In the United States, Essilor of America has acquired the assets of Premier Optics, Inc. and Gold Optical Enterprises, Inc., two prescription laboratories located, respectively, in Belmont and Fayetteville, North Carolina. Essilor has also acquired GK Optical, a group of two prescription laboratories in Greenwood and Fort Wayne, Indiana. The three companies' combined full-year revenue totals $8.5 million.Essilor is one of the leaders in corrective lenses.

The company designs, manufactures and customizes corrective lenses to meet all visual requirements. Worldwide, Essilor offers lightweight, thin, strong lenses that protect eyes and restore perfect vision. The company has 550 researchers at 4 R&D centres.

Federal Circuit Rejects King's Bid for Rehearing in Altace Case

The U.S. Court of Appeals for the Federal Circuit Dec. 3 rejected King Pharmaceuticals Inc.'s bid for a rehearing and rehearing en banc in a case that invalidated the composition of matter patent for the blood pressure medication Altace (ramipril) due to obviousness (Aventis Pharma Deutschland GmbH v. Lupin Ltd., Fed. Cir., No. 06-1530, rehearing denied 12/3/07).

King filed a petition for rehearing or rehearing en banc arguing that the court misapplied the U.S. Supreme Court's 2007 holding in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), which cautions against a rigid application of the "teaching, suggestion, or motivation" (TSM) test for obviousness, to invalidate the Altace patent on the basis of obviousness.

King argued that "this application of the law [in KSR] is not consistent with other recent rulings of the Federal Circuit Court." King also argued that the Federal Circuit's decision in the Altace case (5 PLIR 929, 9/14/07 ) relied on factual inaccuracies.

King said in a statement it was "evaluating its remaining legal options with respect to the patent" after the petition's denial.

If the ruling stands, it means that India-based Lupin Ltd., which is seeking to market generic ramipril capsules before the patent on Altace expires, will be able to enter the market with a generic version of Altace before the patent expiration date of Oct. 19, 2008.

The patent at issue, U.S. Patent No. 5,061,722, (the '722 patent), is held by Aventis Pharma Deutschland GmbH, but Bristol, Tenn.-based King is the exclusive licensee. The '722 patent, which covers ramipril isomers, their hypotensive compositions, and their method of use for reducing blood pressure.

King has called Altace, which in 2006, accounted for $653 million worth of sales for King, its "flagship cardiovascular product."

Sandoz, Zydus sued over epilepsy drug

Abbott Laboratories sued Novartis AG's Sandoz and Cadila Healthcare Ltd.'s Zydus to prevent them from selling generic versions of the epilepsy drug Depakote ER in the U.S.

Sandoz, the world's second-largest generic drug-maker, and Zydus are separately seeking U.S. Food and Drug Administration approval to sell copycat versions of the medicine, whose active ingredient is divalproex sodium. Abbott contends the generic drugs would infringe four patents for the controlled-release version of Depakote that expire in 2018.

In their applications, Sandoz and Zydus said they wouldn't infringe the patents "but did not argue that any of these patents are invalid or unenforceable," North Chicago-based Abbott said in the complaints. It contends the generic versions would infringe the patents and seeks a court order to prevent regulatory approval of the applications until the patents expire.

Sutura settles patent litigation with Abbott

Saturday, December 08, 2007 09:00 IST Fountain Valley, CaliforniaSutura, Inc, a California-based medical device company, said it has settled a patent infringement lawsuit it had against Abbott Laboratories. Abbott has agreed to pay Sutura $23 million as part of the settlement agreement.

The settlement provides for a cross license of the Hathaway patents, licensed to Abbott by Indiana University, and the Sutura Nobles patents.

"We are pleased to have reached this agreement with Abbott and resolved this patent infringement dispute with them," said David Teckman, president and CEO, Sutura. "We now look forward to moving on with our continued enhancement of Sutura's product line of vascular suturing devices, in particular the Sutura EL device."

Sutura, Inc. is a medical device company that has developed a line of innovative, minimally invasive, vascular suturing devices to suture the puncture created in arteries during open surgery and catheter-based procedures.

ImClone and Sanofi-Aventis Settle Patent Litigation with Yeda Research and Development Corporation

NEW YORK--(BUSINESS WIRE)--Dec. 7, 2007--ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel cancer therapeutics, today announced that it has signed a settlement agreement with Yeda Research and Development Company Ltd. and Sanofi-Aventis to end worldwide litigation related to U.S. Patent No. 6,217,866 (the "866 Patent") and its foreign counterparts. All terms of the settlement agreement have been finalized and the parties will submit stipulations to the appropriate courts and patent offices in the various jurisdictions.

Under the terms of the settlement agreement, the companies agree that Yeda is the sole owner of the 866 Patent in the U.S., and Yeda and Sanofi-Aventis are co-owners of the 866 Patent's foreign counterparts. Pursuant to the terms of the settlement agreement, ImClone and Sanofi-Aventis will each pay Yeda $60.0 million in cash for full and final settlement of the claims and counterclaims in the matter. ImClone shall be granted a worldwide license to technology patented under the 866 Patent. ImClone will make a contingent payment to Yeda of a low single-digit royalty on sales in and outside of the U.S. and will pay Sanofi-Aventis a low single-digit royalty on sales outside of the United States. ImClone's worldwide royalty rate for ERBITUX sales pursuant to the settlement agreement remains unchanged.

"This settlement agreement with Yeda and Sanofi-Aventis further solidifies our ability to maximize the commercialization of ERBITUX in the U.S. and abroad going forward," said John H. Johnson, Chief Executive Officer of ImClone. "With this settlement, we have now successfully resolved two important patent litigation claims this year through mutually beneficial agreements that enhance the future commercial and financial potential for ImClone and ERBITUX."

Apotex Loses Patented Process Merck Was Already Using After Court Agrees It Wasn?t Concealed

In an appeal by Apotex, the Court of Appeals for the Federal Circuit affirmed a summary judgment in favor of Merck that Merck had been using a process before it was patented by Apotex. Apotex v. Merck & Co. (06-1405)

Apotex Corp. appeals the decision of the United States District Court for the Northern District of Illinois 1 granting summary judgment in favor of Merck & Co. in an action by Apotex to set aside a judgment on charges of fraud. Apotex also asserted state law claims against Merck for common law fraud and tortious interference with prospective economic advantage, and sought to compel discovery pursuant to the crime fraud exception to the attorney-client privilege. The judgment of the district court is affirmed.

Apotex sued Merck alleging that its process for formulating and producing tablets of the pharmaceutical compound enalapril (Vasotec) used to treat high blood pressure) infringed Apotexs U.S. Pat. No. 5,573,780 and No. 5,690,962 .

Jubilant in drug discovery pact with Forest Labs

Thursday, December 06, 2007 18:15 IST Our Bureau, Mumbai

Jubilant Biosys, a subsidiary of Jubilant Organosys have entered into the collaboration agreement to discover small molecule drug candidates for a novel metabolic disorders target with Forest Laboratories. Jubilant Biosys will conduct the drug discovery work and Forest will have responsibility for the subsequent pro-clinical and clinical development. Forest will own the drugs discovered under the collaboration with unencumbered worldwide commercialization rights. Under the terms of the collaboration, Forest will pay Jubilant undisclosed amounts towards research funding, development and commercialization milestones.

Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co-chairman and managing director of Jubilant Organosys, said, ``We are very pleased to partner with Forest Laboratories, an important pharmaceutical company. This collaboration leverages the innovation capabilities of Jubilant Biosys in pharmaceutical discovery and pre-clinical development, as well as combining these strengths with Forest Laboratories, a proven successful development and commercialization company, to deliver new products with cost effective efficiency that will help patients around the world. This partnership continues to demonstrate Jubilant`s strategy to be Indias`s largest innovation driven integrated pharmaceutical services provider supporting the global pharmaceutical industry``.

Ivan Gergel, senior vice president of scientific affairs and president of the forest research institute, said, "This partnership is part of forest laboratories continued effort in India to access and develop robust partnerships to grow our discovery pipeline and access innovation across the globe. We are very pleased with Jubilant's quality of people capabilities and infrastructure for pharmaceutical discovery".

Sun Pharma Announces Settlement of Litigation Over Generic Exelon

MUMBAI, India, Dec. 6, 2007-Sun Pharmaceutical Industries Ltd. announced that it has executed a settlement agreement with Novartis stipulating a dismissal of the lawsuits filed in the United States against the Company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Exelon, rivastigmine tartrate capsules.

Earlier, USFDA had granted final approval for the Company's ANDA to market its generic Exelon®.

Under the terms of the settlement agreement, Sun Pharma will not market generic Exelon® in the U.S. until sometime prior to the expiration of the patents covering Exelon®. The specific date on which Sun may launch and the other terms of the agreement are confidential.

District Court Upholds Validity of Pfizer's Accupril Patent, Rejecting Teva's Nonenablement Argument

Warner-Lambert v. Teva Pharms. USA, No. 99-922 (D.N.J. 2007)

Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva's ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a paragraph IV certification to U.S. Patent No. 4,743,450. According to Teva's 2002 approval letter, Teva also filed its ANDA with a paragraph III certification to U.S. Patent No. 4,344,949, which expired on October 3, 2002, and section viii statements to U.S. Patent Nos. 5,684,016 and 5,747,504.

The '450 patent broadly claims pharmaceutical compositions containing an ACE inhibitor, "an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration," and "a saccharide to inhibit hydrolysis." The '450 patent did not expire until February 24, 2007, with pediatric exclusivity extending until August 24, 2007.

In October 2003, the district court granted Warner-Lambert's motion for summary judgment of infringement of claims 1, 4-10 and 12 of the '450 patent. The court also granted Warner-Lambert's motion for summary judgment of validity of the same claims. Following a trial in May 2004, the district court ruled that claims 16 and 17 are valid, and that the '450 patent is not unenforceable due to inequitable conduct. Teva appealed the findings of infringement, no invalidity for lack of enablement, and no inequitable conduct, and in August 2005, the Federal Circuit reversed the district court's rulings on infringement and enablement and remanded the case for further proceedings. In January 2006, the district court granted Warner-Lambert's motion for summary judgment of infringement, leaving the issue of enablement for trial.

The district court held a trial on the question of enablement on May 2 and 3, 2007, and released an opinion last week finding the claims enabled. The court applied the standard test: whether the specification provides "sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation." Teva argued that the claims of the '450 patent are extremely broad and the specification provides insufficient guidance to develop the full range of pharmaceutical formulations encompassed by the claims. In addition, Teva argued that numerous failures to arrive at operative embodiments of the claims proved nonenablement. The court, however, found the testimony of Warner-Lambert's expert witness (who "wrote the book on stability of pharmaceutical formulations") to be more persuasive than the testimony of Teva's expert. The court was convinced by Warner-Lambert's expert that one skilled in the art could readily practice the full scope of the claimed invention through routine experimentation. In addition, the court found that none of the purported "failures" proffered by Teva were evidence of lack of enablement.

Last week's court decision could impact other cases in which the '450 patent has been asserted. For instance, Warner-Lambert filed suit against Teva and Ranbaxy in January 2005, after Teva announced that it began shipping generic quinapril HCl tablets in partnership with Ranbaxy. In addition, Schwarz Pharma AG, an exclusive licensee of the '450 patent, has asserted the patent against in litigation concerning generic versions of Univasc (moexipril).

Apotex Buys Spain’s Lareq

Apotex has acquired Spanish generic drugmaker Lareq Pharma in a bid to expand its presence in Western Europe.

Lareq is the 13th-largest player in the Spanish retail pharmacy generics segment, while Spain is the seventh-largest pharmaceutical market in the world, Apotex said.

“The Spanish generics market is a fast-growing market, and all the major international generics competitors are present here,” Andrew Kay, president of Apotex International, said.
Furthermore, the Canadian firm said it sees Western Europe as a launching pad for the products in development for the European market. Last month Apotex announced plans to acquire Topgen, the seventh largest generic drugmaker in Belgium. The company did not disclose the price of either acquisition.

Apotex also has presence in Australia, New Zealand, Mexico, the Czech Republic, Italy, the Netherlands, Poland and the UK. The company said it plans to spend $2 billion on R&D over the next 10 years, and it currently has more than 600 products in development.
Analysts at the International Generic Pharmaceutical Alliance’s annual conference last week said that because growth of the U.S. pharmaceutical market is expected to slow down, it is a good idea for companies to go global. “There’s a huge growth opportunity outside the U.S.,” Randall Stanicky, vice president of global investment research at Goldman Sachs, said. — Breda Lund

Santarus licenses omeprazole rights to GSK

Wednesday, December 05, 2007 10:00 IST San Diego

Santarus, Inc, a specialty pharmaceutical company, said it has signed over exclusive rights related to its prescription and over-the-counter immediate-release omeprazole products including Zegerid to GlaxoSmithKline plc (GSK).

The $11.5 million transaction is to commercialise the drugs for a number of markets in GSK's International Region (including Africa, Asia, the Middle-East, and Central and South America), and to distribute and sell Zegerid brand prescription products in Puerto Rico and the US Virgin Islands (USVI).

Under the license agreement, GSK will be responsible for the development, manufacture and commercialisation of Licensed Products in up to 114 countries, excluding the US, Europe, Australia, Japan and Canada. In addition, under a separate distribution agreement, GSK will distribute, market and sell Zegerid brand prescription products in Puerto Rico and the USVI beginning in the first quarter of 2008. GSK will bear all costs for its activities under the license and distribution agreements.

GSK will pay Santarus an $11.5 million upfront fee and tiered double digit royalties, subject to reduction in certain circumstances, on net sales of any products sold under the license and distribution agreements. The term of the license agreement continues so long as GSK is obligated to pay royalties and the term of the distribution agreement continues as long as GSK sells the products, unless the agreements are terminated earlier by either GSK or Santarus under specified circumstances. GSK has an option to make a buy-out payment 20 years after the effective date of the agreements, after which time, GSK's royalty obligations generally would end. To support GSK's initial launch costs, Santarus will waive the first $2.5 million of aggregate royalties payable under the license and distribution agreements.

"As a leading global pharmaceutical company, GSK has well established international commercialisation capabilities. We believe its demonstrated success in the gastrointestinal therapeutic area make GSK an ideal partner for Santarus in the covered markets," said Gerald T. Proehl, president and chief executive officer, Santarus. "We also believe this relationship with GSK is a major advancement of our strategic objective to leverage our immediate-release proton pump inhibitor intellectual property in international markets and to further diversify our potential sources of future revenues." "This agreement combines GSK's commercial strength in these countries with a great opportunity in the form of ZEGERID immediate-release omeprazole products," commented Dr. Russell Greig, president, GSK Pharmaceuticals International.

Akorn, Inc. Announces First ANDA Submission For Serum Institute of India, Ltd.

BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Dec 5, 2007 - Akorn, Inc. (NASDAQ:AKRX) today announced that it has submitted the first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs on behalf of Serum Institute of India, Ltd. Akorn and Serum announced the signing of an exclusive drug development and distribution agreement for 16 anti-cancer injectable products in October 2004. Since then, Serum has constructed and validated a dedicated, state-of-the art manufacturing facility for producing liquid and lyophilized oncolytic drug products.

The submitted ANDA is a drug product that is given as a treatment for many different types of cancer, and has an estimated U.S. market size of approximately $53 million. Akorn expects to launch the drug product in 2010.

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

DETROIT, December 05, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).

Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc(R), a registered trademark of Pfizer Inc. According to IMS Data, based upon the most recent quarterly sales ended September 2007, Amlodipine generic and brand products combined have a run rate of approximately $550 million with ten generic competitors.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 various strengths."

Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets

PITTSBURGH, December 04, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Matrix Laboratories Limited* has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate Tablets, 300 mg. Matrix's Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Inc.'s Viread Tablets, 300 mg.

Matrix's ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by Matrix within the last 12 months. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment in certain countries outside of the United States. Although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing in the United States, which helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public.

Mylan Vice Chairman and CEO Robert J. Coury said: "This is yet another milestone for Mylan and Matrix and their commitment to the Company's growing antiretroviral (ARV) franchise that includes active pharmaceutical ingredients (API) and finished dosage forms for first- and second-line treatments. We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short timeframe. Tenofovir Disoproxil Fumarate will help to meet the urgent and increasing need for high quality, affordable treatment in the developing world where the prevalence of HIV/AIDS is socially and economically devastating."

Watson and Biovail Settle Lawsuit Over Cardizem LA

- Watson to Launch Generic Version in April 2009 -

CORONA, Calif., December 04, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Biovail Laboratories International SRL on outstanding patent litigation against Andrx Pharmaceuticals, Inc., a subsidiary of Watson, related to Andrx's generic version of Cardizem(R) LA (diltiazem extended-release tablets).

Under the terms of the settlement agreement, Biovail has granted Watson an exclusive license to its U.S. patents covering Cardizem(R) LA for a generic version of Cardizem(R) LA. The agreement generally provides that Watson will not commence marketing its generic equivalent product until April 1, 2009. Other details concerning the settlement have not been disclosed.
Forward-Looking Statement Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of litigation; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities, including the U.S. Department of Justice and /or the Federal Trade Commission; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2006.

Pfizer wins lawsuit against Ranbaxy

Bloomberg / Mumbai December 02, 2007

Pfizer, the world’s biggest drugmaker, won a US court ruling that prevents Ranbaxy Laboratories from selling a generic version of the blood pressure medicine Caduet until 2010.

District Judge Joseph J Farnan ruled that Ranbaxy already lost its bid to invalidate one Pfizer patent, so it can’t renew the argument. The patent covers the cholesterol treatment Lipitor, the world’s best-selling medicine. Caduet combines Lipitor with Pfizer’s Norvasc, which has lost patent protection.

Ranbaxy’s challenge to the patent “was raised and litigated to a final judgment on the merits in the Lipitor litigation between these same parties,” said Farnan in an opinion issued yesterday in Wilmington, Delaware.

New York-based Pfizer also is seeking to block generic Caduet until a second patent, for the combination of Lipitor and Norvasc, expires in 2018.

The judge has yet to rule on this request.

Pfizer reported $265 million in Caduet sales in the first half of 2007.

Lipitor had $6.1 billion in sales in the same period.

Discovery denied in continuations litigation

A court in the Eastern district of Virginia has denied a request from Glaxo SmithKline and Tryantafyllos Tafas for discovery in their case against the USPTO.

GSK and Tafos are involved in litigation over the USPTO's implementation of its final rule on claims and continuations.

The rules were originally set to take effect from November 1, 2007, but the office was enjoined from implementing them on October 31, 2007, when Judge James Chacheris ordered a preliminary injunction in response to requests from GSK and Tafos.

But on tuesday the court refused to grant them discovery.

GSK was seeking discovery of certain documents relating to the USPTO's research into possible alternatives to the final rules. The USPTO moved to block all discovery, and the Judge ultimately decided in its favour.

Despite the setback, neither John Desmarais, GSK's lead attorney, nor Steven Moore, Tafas's Attorney thinks the outcome of the hearing will affect their clients ability to win the case while GSK could appeal the decision in the district court.

Patent Challenge Taking The Glee Out Of Gleevec

An Indian drugmaker has filed a patent challenge with the FDA against the best-selling cancer med. And already, some patent experts and generic drugmakers are predicting this development will cause problems for Novartis in India, where the company is fighting a rejection of its Gleevec patent application. Novartis already lost one battle in which a court ruled its Gleevec patent lacks innovation.
India’s Sun Pharmaceuticals has filed a so-called Paragraph IV challenge with the FDA in which a generic maker seeks to invalidating a patent, prove there’s nothing novel about the med, or propose to introduce a version without infringing on the patent, as LiveMint reminds us. A Novartis spokesman confirms the Sun challenge, and vows the drugmaker will defend its intellectual property.
Sun is reportedly looking to invalidate the existing patent and experts say a victory will strengthen generic companies in their claims against Novartis in India, where Novartis has challenged the patent office’s decision to turn down its application. “This very disclosure in the US will make Novartis’ appeal against the patent office’s decision to reject its (Gleevec) patent application unacceptable,” Gopakumar Nair, a patent expert in Mumbai, tells LiveMint.
Moreover, some say a successful challenge would open a large generics market for Indian companies in the US. “If the US, which is comparatively liberal in granting patents, invalidates the Gleevec patent, it will look ridiculous for any (of the) patent court(s) in the world, which are (usually) more cautious, to grant a patent for this drug,” Shamnad Basheer, an associate at Oxford IP Research Center in the UK, tells LiveMint.
Rajeev Nannapaneni, ceo at Natco Pharma, which is opposing Novartis at India’s Intellectual Property Appellate Board, tells LiveMint that “the US patent challenge gives us a most important message that the Gleevec patent has been questioned not only in India, but elsewhere also.”
A Novartis spokesman writes us to say such views are premature: “Sun filed the Paragraph IV certification against a Gleevec patent that expires in the US in 2019. The basic compound patent, which expires in 2015 in the US, is not being challenged. So the earliest a generic could be launched - and this is only if Sun is successful in its challenge - would be after the expiry of the compound patent in 2015. We have full confidence in the integrity of these patents.”

Lovenox Patent Case Back at Federal Circuit; Generic Versions Still Not Yet Approved

The Lovenox patent infringement litigation between Aventis and Teva/Amphastar is making its second trip to the Federal Circuit. In February, following remand from the Federal Circuit last year, a federal district court in California held that the Lovenox patent is unenforceable due to inequitable conduct. The appeal may emerge as a litmus test of how far the CAFC is willing to go in lowering the bar on inequitable conduct, especially in terms of what it takes to prove deceptive intent. In general, the party asserting inequitable conduct must prove each prong of inequitable conduct (i.e., materiality and deceptive intent) by clear and convincing evidence.
In recent cases, the CAFC has expanded the scope of what counts as a material omission, including the omission of information that would have had no bearing on patentability. Thus, a practitioner may even comply with Rule 56 (37 CFR 1.56), and still be found to have withheld material information. This bar-lowering has occurred primarily via the emergence of the "reasonable examiner" standard. Hence, materiality is judged not by the PTO’s rules, but by a post hoc litigation-induced evaluation of what information a hypothetical "reasonable examiner" would (or should) have wanted during the ex parte prosecution of the patent application.
Moreover, defendants may no longer need to prove deceptive intent by clear and convincing evidence. Instead, a "guilt by omission" standard seems to have emerged. If the omitted information is "highly material" and if the patentee cannot proffer a reasonable explanation for the omission, then a court is permitted to infer deceptive intent. (Of course, the line between ordinary materiality and "high materiality" is a bit fuzzy, especially if an omission can be highly material even when it would have had no effect on patentability.)

In the Lovenox district court case, the district court went one step further: The court appeared to have shifted the burden to Aventis to disprove deceptive intent (e.g., after finding that Teva/Amphastar had made out a prima facie case of deceptive intent). It will be interesting to see where the CAFC goes with this one.
The parties appear reluctant to tread into the legal issues surrounding the CAFC’s recent inequitable conduct jurisprudence. After all, a sizeable portion of the judges have not yet bought into the recent trend of making it easier to prove inequitable conduct. Instead, the parties have elected to focus on several alleged clear errors in the district court’s fact-finding. Perhaps that’s the best approach, anyway. By their very nature, inquires into an individual’s intent must be fact-intensive.

Of course, the CAFC may do well to pay more heed to the post-1978 developments in antitrust law, where scholars of all stripes have generally rejected the value of intent-based evidence. Inequitable conduct arose in 1945 and came of age during that era of legal moralism that emerged from antitrust cases like Standard Oil. Antitrust law has now largely unburdened itself of Standard Oil and its progeny. To the degree that inequitable conduct is a relic of that bygone age, why must we retain it in patent law?

Meanwhile, the FDA has still not yet approved any generic versions of Lovenox (enoxaparin sodium). Lovenox consists of a complex mixture of oligosaccharides that has been shown to have improved anticoagulant effects over other low-molecular-weight heparins (LMWHs).
Earlier this month, Momenta Pharmaceuticals announced that the FDA rejected its ANDA for M-enoxaparin, apparently based on concerns about the generic drug’s immunogenicity. In other words, the FDA was concerned that it may provoke an unwanted immune response in humans. Moreover, according to Momenta's press release, "the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product."
Momenta is working with Swiss generic manufacturer Sandoz to develop its generic product. The news of the rejection caused Momenta’s stock to lose nearly 60% of its value in a single day. In the intervening weeks, Momenta’s stock value has continued to tumble another 4 - 5%