Macugen
pegaptanib
Treatment for Macular DegenerationEyetech/Pfizer Announce FDA Acceptance of the New Drug Application for Macugen (pegaptanib sodium injection)
The First Investigational Anti-VEGF Therapy for Neovascular Age-Related Macular Degeneration Granted Priority Review
NEW YORK, August 17, 2004 -- Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET) and Pfizer Inc. (NYSE:PFE) today announced that their complete New Drug Application (NDA) for Macugen (pegaptanib sodium injection) has been accepted by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA satisfied a milestone provision in our collaboration agreement for a further license fee payment from Pfizer to Eyetech of $10 million. Eyetech and Pfizer are partnering to develop and market Macugen, a treatment for neovascular age-related macular degeneration, the leading cause of severe vision loss in patients older than 50 years of age in the developed world.
As part of the Macugen NDA filing, Eyetech and Pfizer requested and have now been granted Priority Review designation from the FDA. Based on the Priority Review designation, the FDA has six months from the submission date, to take action on the NDA filing. The companies submitted the final portion of the NDA, the chemistry, manufacturing and controls (CMC) component, on June 17, under the FDA's Fast Track designation. The FDA and its Dermatologic and Ophthalmic Drugs Advisory Committee will review Macugen on August 27, 2004.
Macugen is a pegylated anti-VEGF aptamer, which binds to and thus inhibits the activity of vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with neovascular AMD.
About Eyetech Pharmaceuticals, Inc.
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that
specializes in the development and commercialization of novel
therapeutics to treat diseases of the eye. Eyetech's initial focus
is on diseases affecting the back of the eye. The company's most
advanced product candidate is Macugen (pegaptanib sodium
injection), which Eyetech is developing with Pfizer Inc for the
prevention and treatment of diseases of the eye and related
conditions. Eyetech's lead clinical trials include two phase 2/3
pivotal clinical trials for the use of Macugen in the treatment of
neovascular age-related macular degeneration, a phase 2 clinical
trial for the use of Macugen for the treatment of diabetic macular
edema and a phase 2 clinical trial for the use of Macugen in the
treatment of retinal vein occlusion.
For more information, please visit www.eyetech.com.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines for humans and animals in many of the
world's best- known consumer brands.
For more information, please visit www.pfizer.com.
About Pfizer Ophthalmics
Pfizer Ophthalmics, a division of Pfizer Inc, is dedicated to
preserving sight and preventing blindness in patients with ocular
diseases.
Related Articles:
Macugen Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration - December 17, 2004
FDA Advisory Committee Reviews Clinical Data of Eyetech/Pfizer Priority 1 NDA Submission for Macugen, an Investigational Treatment for Neovascular AMD - August 27, 2004
FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection) - May 26, 2004
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