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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (327)	12/14/2005 2:57:04 PM
From: tuck	Read Replies (1) \| Respond to of 447

>>MELVILLE, N.Y.--(BUSINESS WIRE)--Dec. 14, 2005--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP - News) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has advised Pfizer Inc, (OSI) Eyetech's international marketing partner for Macugen®(pegaptanib sodium injection), that it will issue an updated positive opinion recommending approval of Macugen for the treatment of neovascular (wet) age-related macular degeneration (neovascular AMD). The reason for this updated opinion is to include updated label information related to rare occurrences of hypersensitivity during the administration of Macugen. It is unclear whether or not the hypersensitivity is associated with Macugen or the anaesthetics and antibiotics which are co-administered with Macugen. OSI now anticipates European Union approval of Macugen in January 2006 and still anticipates launch in the first quarter of 2006. Macugen was approved by the U.S. Food and Drug Administration in December 2004 and by Brazilian regulatory authorities in May 2005 for use in the treatment of neovascular AMD. In May 2005, Canadian regulatory authorities approved Macugen for the treatment of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration. Macugen is currently available in the U.S. and Canada. Applications to market and sell Macugen also have been filed in twelve additional countries. (OSI) Eyetech, and Pfizer Inc. co-promote Macugen in the United States. (OSI) Eyetech has granted Pfizer the exclusive rights to commercialize Macugen in countries outside the United States pursuant to a royalty-bearing licensing agreement.<< snip This constitutes a slight delay, apparently because EMEA wasn't quite going to get the job done before the holidays. However, with launch over there still on track, OSIP is responding positively to the news. Cheers, Tuck