Regeneron finally captures an FDA OK with new eye drug

Late on Friday Regeneron Pharmaceuticals ($REGN) scored a big win as it announced that the FDA has approved Eylea (aflibercept) for wet, age-related macular degeneration. But after pricing an injection at a slight discount to Roche's Lucentis--$1,850 to $1,950--most of the market buzz centered on the $50 competitor available from an off-label dose of Genentech's Avastin.

As The New York Times' scribe Andrew Pollack noted, Regeneron has racked up $1.2 billion in losses as it spent its way through 24 years of R&D, often plagued by setbacks in the clinic. But the approval marks a solid achievement for CEO Leonard Schleifer, who holds the title for longest-running chief in the biotech industry.

"We thought that good science would win out a little earlier, but we are patient," he told Pollack.

He'll need all the patience he can muster on this next step. Eylea has an edge on Lucentis, with an injection needed every eight weeks--significantly less frequent than Lucentis. And almost every practitioner will tell you that patients are highly motivated to reduce the number of injections they need in their eyes. But the much cheaper off-label Avastin has a solid hold on 60% of the market, according to Bloomberg.

"Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements," said Jeffrey Heier, M.D., a clinical ophthalmologist, in a release from Regeneron. 

- read the press release
- get the story from The New York Times
here's the Bloomberg report

Special Report: Regeneron Pharmaceuticals - Biotech's Biggest Spenders 2011