The folks at Regeneron (NASDAQ: [[ticker:REGN]]) had plenty to be thankful for the Friday before Thanksgiving, when late in the day, the FDA approved aflibercept (Eylea), the Tarrytown, NY-based biotech company’s drug to treat age-related macular degeneration, the leading cause of blindness in elderly people. It was a happy ending to a long and sometimes frustrating process for Regeneron, which included a request from the FDA for additional information about the drug and ultimately a three-month delay on the approval decision. In the end, says Robert Terifay, Regeneron’s senior vice president for commercial, “They accepted everything we asked for. We were very pleased.”
Now Regeneron—a 23-year-old company with just one small product before this one—is gearing up to enter a huge and extremely competitive market. The prevalence of age-related macular degeneration (AMD) has exploded along with the aging of the population. About 200,000 new cases of the “wet” form of the disease, marked by leaky blood vessels at the back of the eye, are diagnosed each year in North America, according to the American Macular Degeneration Foundation. Hence pharma companies both large and small have joined the hunt for new ways to tackle the disease. This despite the fact that the market is dominated by a formidable competitor: ranibizumab (Lucentis), the $3-billion-a-year blockbuster from Roche unit Genentech.
What Regeneron and other players in the eye-disease market are all trying to provide is an easier way to treat AMD. No one disputes that ranibizumab, says Terifay, “was a major breakthrough.” The drug not only slows down the vision loss that AMD causes, but it sometimes reverses the decline, allowing many patients to start driving again or even to go back to working. But the drug requires a monthly injection directly into the eye—a process that in and of itself can be risky, not to mention a hassle for patients. And it’s expensive, with a price tag of about $1,950 per injection.
Regeneron’s marketing message focuses on both the cost and convenience of aflibercept. The drug is similar to ranibizumab in that it targets VEGF, a protein involved in the abnormal blood-vessel formation that causes AMD. But the label for Regeneron’s drug says it only has to be given monthly for the first three months, after which
