Eyetech Jumps on FDA OK

Eyetech Pharmaceuticals(EYET) shares jumped early Monday after the company and its partner Pfizer(PFE) won regulatory approval late Friday for their vision loss treatment.

The companies will soon begin marketing a drug that analysts say offers the best chance for limiting vision loss caused by a disease that primarily affects people 50 and older.

The drug is called Macugen, and the disease is called wet age-related macular degeneration, or AMD, which is becoming more prevalent as our population ages. The Food and Drug Administration approved the drug Friday night by granting it the widest possible use for treating wet AMD, also known as neovascular AMD. The companies say the drug will be available during the first quarter of 2005.

Eyetech shares jumped $3.65, or 8%, to $49.15 in premarket trading. Pfizer's were up 5 cents, or 0.2%, to $25.80, in the wake of its warning that its painkiller Celebrex posed increased cardiovascular risks during testing as a cancer treatment.

Macugen is the first in a line of potential new products being developed for a disease whose treatments are few and modestly effective. Macugen isn't a cure. It doesn't restore lost eyesight, but it helps preserve vision and helps limit progression of wet AMD to legal blindness.

Macugen is the first commercial product for Eyetech, which was founded in 2000 and went public at $21 a share earlier this year.

Macugen also provides some good news for embattled Pfizer, which signed a marketing and development deal with Eyetech in 2002. As part of that deal, the FDA approval means Eyetech will receive a $90 million milestone payment from Pfizer and Pfizer will buy $15 million of Eyetech's shares within 35 business days.

Macugen treats a disease that is the "leading cause of irreversible severe vision loss in patients older than 50 years of age in developed countries," the companies said Friday. The disease affects some 1.6 million Americans and is adding new U.S. patients at the rate of 200,000 a year, they added.