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Regeneron/Bayer Eye Drug Works As Well as Lucentis

From Associated Press (November 22, 2010)

TARRYTOWN, N.Y. -- Shares of Regeneron Pharmaceuticals Inc. spiked early Monday after the drug developer and partner Bayer AG said their potential injectable treatment for the eye disease wet age-related macular degeneration worked as well as Roche’s Lucentis in two late-stage studies.

The companies are developing the VEGF Trap-Eye solution as a treatment for the disease, which results in vision loss as new blood vessels grow beneath the retina and leak blood and fluid, damaging the retina and distorting vision. The condition, which can progress to blindness, usually affects older adults. The "dry" form of the condition is the most common type of age-related macular degeneration, with the "wet" form considered the more advanced version of the disease. There are up to 200,000 new cases for the "wet" form of the condition each year in the U.S. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.

Lucentis is currently the only Food and Drug Administration approved treatment for wet age-related macular degeneration. It generated sales of 697 million Swiss francs during the first half of 2010, or about $702 million.

VEGF Trap-Eye is a human protein that binds vascular endothelial growth factor (VEGF) along with placental growth factor, thereby blocking those chemicals in the body that spark the growth of blood vessels. The companies said VEGF Trap-Eye met its key goal of working as well as Lucentis in two late-stage studies. In a North American study involving 1,217 patients, up to 96 percent of patients receiving VEGF Trap-Eye maintained their vision, compared with 94 percent taking Lucentis. The results were similar for an international study involving 1,240 patients.

Importantly, the drug proved similarly effective for patients receiving the experimental injection every other month and for those being treated every month, which opens up the potential that patients could be treated less frequently. Treatments are injected into the eye.

Regeneron shares rose $2.84, or 11.5 percent, to $27.51 in morning trading.

The companies plan to present additional results from the study at a conference in February and plan to request European and U.S. regulatory approval in the first half of 2011.


Posted: November 2010

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