OSI: European regulators to issue updated label approval of Macugen for age-related macular degeneration

By E. Janene Geiss

Philadelphia, Dec. 14 - OSI Pharmaceuticals, Inc. announced Wednesday that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has advised marketing partner Pfizer Inc., that it will issue an updated positive opinion recommending approval of Macugen for the treatment of neovascular (wet) age-related macular degeneration.

The reason for this updated opinion is to include updated label information related to rare occurrences of hypersensitivity during the administration of Macugen, according to a company news release.

It is unclear whether or not the hypersensitivity is associated with Macugen or the anaesthetics and antibiotics that are co-administered with Macugen, officials said.

OSI said it now anticipates European Union approval of Macugen in January and still anticipates launch in the first quarter of 2006.

Pfizer is an international marketing partner of (OSI) Eyetech, a business team of OSI that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye.

(OSI) Eyetech and Pfizer Inc. co-promote Macugen in the United States, and it has granted Pfizer the exclusive rights to commercialize Macugen in countries outside the United States pursuant to a royalty-bearing licensing agreement, officials said.

Macugen was approved by the Food and Drug Administration in December 2004 and by Brazilian regulatory authorities in May 2005 for use in the treatment of neovascular age-related macular degeneration. In May 2005, Canadian regulatory authorities approved Macugen for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration. Macugen is currently available in the United States and Canada. Applications to market and sell Macugen also have been filed in 12 additional countries, officials said.

OSI is a Melville, N.Y., pharmaceutical company focusing on development and commercialization of drugs to treat cancer, eye diseases and diabetes.

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