The European Medicines Agency (EMEA) has accepted the filing of Pfizer -Eyetech Pharmaceuticals Inc's marketing authorization application for Macugen (pegaptanib sodium injection), the first in a new class of medicines for neovascular age-related macular degeneration (AMD).
The companies also announced that they have completed the filing of a new drug application for Macugen in Canada, where it has been given priority review, and have begun clinical trials with the medicine in Japan.
Under the terms of the Pfizer/Eyetech collaboration agreement, Pfizer will market Macugen for the prevention and treatment of diseases of the eye and related conditions outside the United States, and pay Eyetech a royalty on net sales. The two companies will co-market the drug in the United States. Macugen is currently under priority review with the US Food and Drug Administration, a release from Pfizer said.
The AMD Alliance International estimates that 500,000 new cases of neovascular AMD are diagnosed annually worldwide. The disease is the leading cause of severe vision loss in patients over 50 years of age in the developed world.
Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in the formation of unwanted new blood vessels and increased leakage from blood vessels, two of the primary processes responsible for the vision loss associated with neovascular AMD.
Eyetech Pharmaceuticals Inc is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye. The company's 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.