Macugen Receives Positive Opinion From Europe's CHMP for Treatment of Wet Age-Related Macular Degeneration
Posted on: Friday, 16 September 2005, 09:00 CDT
NEW YORK, Sept. 16 /PRNewswire-FirstCall/ -- Pfizer Inc said today that the Committee for Human Medicinal Products (CHMP) has adopted a positive opinion recommending marketing authorization of Macugen (pegaptanib sodium injection) in the European Union for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Pfizer anticipates the European Commission to grant a marketing authorization by the end of the year.
AMD is an eye disease associated with aging that destroys central vision. In the EU, AMD is the leading cause of irreversible severe vision loss in patients over 50 years of age. An estimated 500,000 people worldwide lose their vision each year from this disease.
Developed in partnership with Eyetech Pharmaceuticals Inc., Macugen will be marketed in Europe exclusively by Pfizer. Pfizer and Eyetech co-promote Macugen in the United States where the medicine was approved by the U.S. Food and Drug Administration in December 2004.
Macugen is the first ophthalmic pharmacological therapy that specifically targets vascular endothelial grown factor (VEGF) 165, a protein that acts as a signal in triggering the abnormal blood vessel growth and leakage that characterize neovascular AMD. Macugen is administered once every six weeks via intravitreal injection.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of September 16, 2005. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a product candidate which is under review by the European Medicines Evaluation Agency (the "EMEA") that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when the EMEA will approve the product candidate, its decisions regarding labeling and other matters that could affect its commercial potential, as well as competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2004 and in its reports on Form 10-Q and Form 8-K.
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Pfizer Inc
CONTACT: Daniel Watts of Pfizer Inc, +1-212-733-3835
Web site: http://www.pfizer.com/
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Company News On-Call: http://www.prnewswire.com/comp/688250.html
Source: PRNewswire-FirstCall
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