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GlaxoSmithKline has identified more than 5,500 rare diseases it potentially could target as part of a new drug-development initiative, the British drug maker announced. GSK said it would start a stand-alone business unit specializing in creating drugs for treating rare diseases, many of them genetic disorders. The company will work with Netherlands-based Prosensa and Japan-based JCR Pharmaceuticals, which it entered collaborations with in 2009. The Prosensa partnership focuses on nucleic-acid-based drugs for Duchenne muscular dystrophy. With JCR, GSK will help develop drugs for Hunter syndrome, Fabry disease and Gaucher disease.

Pfizer has filed a lawsuit against Mylan following a challenge to its patent for a cardiovascular drug, Mylan said. Pfizer filed the suit in the U.S. District Court for the District of Delaware after Mylan filed for regulatory approval of a generic version of Caduet (amlodipine besylate and atorvastatin calcium). Mylan said it was the first company to file for approval of a generic version of Caduet, which entitles it to six months’ market exclusivity in which to directly compete with the branded drug after Pfizer’s patents expire in 2018.

Mylan seeks approval for the drug in the 2.5-mg/10-mg, 2.5-mg/20-mg, 2.5-mg/40-mg, 5-mg/10-mg, 5-mg/20-mg, 5-mg/40-mg 5-mg/80-mg, 10-mg/10-mg, 10-mg/20-mg, 10-mg/40-mg and 10-mg/80-mg strengths.

Caduet had sales of about $65.6 million for the 2.5-mg/10-mg, 2.5-mg/20-mg, 2.5-mg/40-mg and 10-mg/40-mg strengths in 2009, according to IMS Health.

Cephalon plans to buy Switzerland-based Mepha, a private company that makes more than 120 generics and branded generics, for $590 million, the U.S. drug maker announced. Mepha had sales of 400 million Swiss francs (approx. US$374.25 million) in 2009. Cephalon said the acquisition would diversify its business mix, double the size of its international business and provide a platform for launching current and future products in new, developed and emerging markets.

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