Endo's Advisory Committee Cancelled

FDA cancels Dec. 2 advisory committee review of Endo Pharmaceuticals' tamper-resistant extended-release oxymorphone because "the agency believes the information received from previous advisory committee meetings is adequate to allow the agency to address the specific concerns in the application," a Nov. 19 Federal Register notice states. FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees met Oct. 21-22 to discuss post-market trial design issues for anti-abuse formulation opioids, and before that meeting Division of Anesthesia and Analgesia Products Director Bob Rappaport said in a briefing memo that any incremental reductions in abuse are valuable (Also see "Abuse-Resistant Opioids: How Much Deterrence Is Enough For A Labeling Claim?" - Pink Sheet, 19 October, 2010.). The cancelled joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees was to have included a closed session slated to last more than an hour to discuss confidential protocol and methodology information (Also see "Tamper-Resistance Could Allow New Opioid Formulations To Differentiate Themselves" - Pink Sheet, 1 November, 2010.). The tablet formulation was developed in partnership with Grunenthal GmbH, and is supposed to be crush-resistant; it has priority review status with a user fee date of Jan. 7, 2011.

Otsuka Wins Abilify Patent Ruling

A New Jersey District Court judge ruled Nov. 15 that Otsuka’s Abilify (aripiprazole) compound patent is valid and enforceable and enjoined defendants from marketing their generic versions of the antipsychotic until the patent expires in 2015. Otsuka sued Sandoz, Teva, Barr, Apotex, Sun and Synthon for infringement. They argued unsuccessfully that the patent was invalid due to obviousness-type double-patenting and unenforceable due to inequitable conduct. Otsuka's U.S. marketing partner Bristol-Myers Squibb reported $1.85 billion in Abilify sales in the first nine months of 2010.

Lilly’s Alimta Patent Is Upheld

At the conclusion of a bench trial Nov. 15, the U.S. District Court for the District of Delaware ruled that the compound patent for Lilly’s injectable cancer drug Alimta (pemetrexed) is valid. The patent expires in July 2016. Lilly, which holds an exclusive license to the patent from Princeton University, sued Teva Parenteral Medicines, Barr and APP Pharmaceuticals for infringement. The case before the court was Eli Lilly v. Teva Parenteral Medicines. Alimta generated worldwide sales of $1.6 billion in the first nine months of 2010.

Regulatory And Policy News, In Brief

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