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REGN - 2 year data out from the phase 3 this morning. Shareprice down about 5%.

Regeneron Pharmaceuticals, Inc. And Bayer HealthCare Announces Two Year Results Of Phase 3 Studies With EYLEA (aflibercept) Injection In Wet AMD Show Sustained Improvement In Visual Acuity


2:31am EST
Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that in an integrated analysis of two parallel Phase 3 studies (VIEW 1 and VIEW 2) in patients with the neovascular form of age-related macular degeneration (wet AMD), patients treated with EYLEA (aflibercept) Injection For Intravitreal Injection showed a sustained improvement in visual acuity at 96 weeks versus baseline. The 52-week results (primary analyses) from these studies have previously been reported. During the first year of the VIEW 1 and VIEW 2 studies, patients were treated with three different dosing regimens of EYLEA, 0.5 milligram (mg) every four weeks, 2mg every four weeks, and 2mg every eight weeks (following three initial monthly injections), compared to ranibizumab 0.5mg every four weeks. The EYLEA 2mg every eight week regimen was recently approved by the U.S. Food and Drug Administration (FDA), based on efficacy (maintenance of vision) that was clinically equivalent at one year to the monthly ranibizumab regimen. In the second year of the studies, patients were treated with the same dose per injection as in the first year and were evaluated monthly to determine need for retreatment. Patients were treated at least every 12 weeks.

Regeneron-Bayer Drug Matches Lucentis at 2 Years in Fewer Doses

By Meg Tirrell - Dec 5, 2011 1:30 AM CT


Regeneron Pharmaceuticals Inc. (REGN) and Bayer AG (BAYN) said their medicine Eylea matched Roche Holding AG (ROG)’s Lucentis in fewer treatments after two years for people with the vision disorder wet age-related macular degeneration.
Patients on Eylea gained an average of 7.6 letters on an eye chart after 96 weeks, compared with 7.9 for those on Lucentis, Regeneron and Bayer said today in a statement. The drugs were injected on an as-needed basis in the second year, said George Yancopoulos, Regeneron’s chief scientific officer.
Wet AMD, caused by abnormal blood vessel growth behind the retina, is a leading cause of blindness in the elderly. U.S. regulators approved Eylea in November after two studies showed the drug, given once every two months after three initial monthly doses, improved eyesight over one year as well as Lucentis, dosed monthly. The results today showed patients on Eylea had fewer injections in the second year, at 4.2 on average compared with 4.7 for Lucentis.
“The study picked up the fact that, especially for the patients who needed more intense dosing, you could get by with substantially less injections with Eylea,” Yancopoulos said in a telephone interview. That “supports its longer duration of action.”
Both treatment arms showed an average loss of 0.8 letters on the eye chart between 52 weeks and 96 weeks, showing that as- needed dosing isn’t as effective as a fixed regimen, Yancopoulous said.
Regeneron, based in Tarrytown, New York, declined 3.2 percent to $58.28 at the close of trading on Dec. 2. The shares gained 78 percent this year before today. Bayer, based in Leverkusen, Germany, declined 0.1 percent to 47.30 euros, and had fallen 14 percent this year before today.