PHARMACY

Eisai appoints SVP, general counsel

BY Allison Cerra

WOODCLIFF LAKE, N.J. — Eisai announced that Allen Waxman has joined the company.

Waxman, who has worked at such companies as Kaye Schouler LLP and Pfizer, will serve as SVP and general counsel, where he will be responsible for leading the office of the general counsel and all legal matters for the company in the United States. Waxman also will be a member of the company’s executive committee and also will join others in providing leadership for a number of global legal matters for Eisai.

"We are very pleased to welcome Allen to Eisai," Eisai president and CEO Lonnel Coats said. "Allen’s expertise and leadership will help us continue driving sound, ethical and legally compliant business practices here at Eisai, contributing to our company’s human health care mission to help improve the lives of patients and their families."

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Merck wins patent infringement suits against Mylan

BY Alaric DeArment

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug’s patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

Mylan had been seeking Food and Drug Administration approval for generic versions of Zetia and Vytorin, prompting Merck to file suit against it in December 2009 for Vytorin, and in June 2010 for Zetia.


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Mylan to launch generic version of Nuvigil in 2016

BY Alaric DeArment

PITTSBURGH — Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

Mylan said it had settled with Teva over the former’s generic version of Nuvigil (armodafinil) tablets, a drug used to treat sleepiness related to sleep apnea, narcolepsy and shift work disorder.

Mylan plans to sell the generic in the 50-mg, 150-mg and 250-mg strengths. Under the opinion that it was the first company to successfully file for Food and Drug Administration approval of the drug, Mylan said it expects to receive 180 days of market exclusivity in which to directly compete with Teva’s product.

Nuvigil had sales of $296 million in 2011, according to IMS Health. Teva has owned rights to the drug since it finalized its acquisition of Cephalon in October 2011.


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