Regeneron finally captures an FDA OK with new eye drug

Posted under Aflibercept, Avastin, Blog, Companies, Diagnostics, Eylea, Funding, Genentech, Lucentis, macular degeneration, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

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

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FDA pins approval on Regeneron eye drug Eylea

Posted under Avastin, Bayer Healthcare, Blog, Companies, Diagnostics, Eylea, Funding, Lucentis, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Regeneron ($REGN) is wrapping up the week with a big victory. U.S. regulators have given market approval to the Tarrytown, NY-based company's Eylea for treating a neurovascular form of wet age-related macular degeneration, the most common cause of blindness in adults older than 65 in the U.S. and Europe. It's an approval that was highly expected after an FDA advisory committee unanimously backed the drug in June.

The drug, also called VEGF Trap-Eye, was approved for use every month for the first three months of treatment followed by injections every 8 weeks. This makes the drug the first FDA-approved treatment for wet-AMD that can be given less frequently than once per month, according to the company. The less frequent dosing is expected to be a competitive advantage over Roche's existing therapy, Lucentis, which is recommended for use once every month. Eylea's big competition, however, is another Roche product, the cancer drug Avastin, which is used off-label in small doses to treat AMD and has been a more popular option than the more expensive Lucentis. The Wall Street Journal cited analysts who estimated Avastin is used to treat more than two-thirds of AMD cases.

Eylea showed in two late-stage clinical trials that its efficacy in patients getting injections of the drug every 8 weeks was clinically equivalent to patients getting Lucentis in the more frequent monthly doses. The drug blocks the new blood vessel formation observed in patients with wet AMD by inhibiting a vascular growth factor know as VEGF-A. The most common side effects of the drug included conjunctival hemorrhage, eye pain and intraocular pressure, according to the company.

"This approval is an important step forward for Regeneron and for patients suffering with wet AMD,"  Regeneron CEO Leonard Schleifer said in a statement. "Now that Eylea is approved, we plan to make Eylea available to patients within the next few days."

Regeneron controls exclusive rights to Eylea in the U.S. and has partnered with Bayer Healthcare, which will handle marketing of the drug in the rest of the world. Bayer filed paperwork for approval of the drug in Europe in June.

- here's the release
- get more from the FDA's statement
- see the Wall Street Journal's coverage

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