OSI Pharmaceuticals, Inc. Announces Update To Timing Of European Union Approval For Macugen(R)

MELVILLE, N.Y.--(BUSINESS WIRE)--Dec. 14, 2005--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) 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(R)(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.

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