Regeneron Pharmaceuticals Inc (REGN)

[surf1944]

6:15AM Regeneron Pharms and Bayer (BAYRY) reported earlier positive one-year results from two Phase 3 trials of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema (REGN) 270.99 : Co and Bayer HealthCare (BAYRY) announced that in the Phase 3 VIVID-DME and VISTA-DME trials of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. Both EYLEA treatment arms demonstrated similar improvements in BCVA. Based on discussions with the FDA, Regeneron now expects to submit an application for U.S. marketing approval for the treatment of DME in 2013, ~ one year ahead of the previously announced timeline. Bayer Healthcare plans to submit an application for marketing approval for the treatment of DME in Europe in 2013.

In these trials, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across the treatment groups and the laser control group.

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