Regeneron Pharmaceuticals Inc. (REGN)’s experimental treatment for a common cause of blindness prevents vision loss, U.S. regulators said, suggesting they may soon approve the competitor to Roche Holding AG (ROG)’s Lucentis.
The new medicine, known as VEGF Trap-Eye or aflibercept, worked as well as Lucentis when injected into the eye every month or other month in patients with wet age-related macular degeneration, or AMD, Food and Drug Administration staff said in a report released today. Lucentis, a $1.4 billion-a-year product for Basel, Switzerland-based Roche, is given monthly.
Less frequent dosing may help Tarrytown, New York-based Regeneron capture at least 15 percent of the U.S. market from Lucentis if it’s approved, said Robyn Karnauskas, a Deutsche Bank analyst in New York. Most patients will still be treated with Avastin, a Roche cancer drug that’s cheaper than Lucentis though not FDA approved for treating the eye disease, she said.
“VEGF Trap-Eye doesn’t need to take a lot of the market for it to mean something to Regeneron,” Karnauskas said in a telephone interview. She estimates the medicine will generate global sales of $2 billion in 2018.
Outside advisers to the FDA will meet June 17 in Adelphi, Maryland, to consider the data on Regeneron’s drug and recommend whether it should be approved. The agency is scheduled to take action by Aug. 20 under a six-month priority review program for medicines that represent a major advance in treatment.
The FDA asked its advisers to consider whether patients on the new medicine should be monitored every month even if recommended dosing of the drug is every two months. The advisory panel will also consider draft labeling for the product, which was “very favorable for Regeneron,” Karnauskas said.
“We think the FDA is likely to approve Trap-Eye with a dosing regimen that would make it competitive to both Lucentis & Avastin,” Karnauskas said today in a note to clients.
Regeneron rose $2.79, or 5.1 percent, to $57.82 in Nasdaq Stock Market composite trading at 4 p.m. New York time, the biggest percentage gain since May 6. The shares have increased 76 percent this year, outperforming the 9 percent average gain among 20 stocks in the AMEX Biotechnology Index. Paris-based Sanofi-Aventis SA (SAN) is the company’s biggest investor with an 18 percent stake as of Oct. 13, according to data compiled by Bloomberg.
AMD is a leading cause of blindness in Americans age 60 and older, according to the National Eye Institute. About 15 percent of patients have the more advanced “wet” form of the disease tied to abnormal blood vessels that grow under the macula, the part of the retina responsible for seeing in fine detail. Blood and fluid leaked from the vessels can result in vision loss.
1.5 Million Patients
Regeneron estimates that about 1.5 million people have wet AMD with 200,000 new cases diagnosed each year.
Regeneron proposed the brand name Eylea to the FDA. Bayer AG (BAYN), of Leverkusen, Germany, has rights to market VEGF Trap-Eye outside the U.S. and this month submitted an application in Europe for use in wet AMD.
Lucentis is sold outside the U.S. by Novartis AG (NOVN), also based in Basel, Switzerland. The drugmaker reported Lucentis sales of $1.5 billion last year.
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