Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., has submitted an application for marketing authorization for EYLEA^® (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and Welfare (MHLW).

"Clinically significant DME is a leading cause of vision loss in the working-age population suffering from diabetes.  With increasing rates of diabetes worldwide, there continues to be a need for new treatment options," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We are pleased with this regulatory submission and hope that if approved, EYLEA will provide a new option for the treatment of DME in Japan."  

The submission of EYLEA for DME in Japan is based on data from the VISTA-DME, VIVID-DME and VIVID-Japan studies.  In the Phase 3 VIVID-DME and VISTA-DME trials, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) achieved the primary endpoint of significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks.  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.  The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous floaters.  The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group.

One-year data from the VIVID-DME and VISTA-DME trials have been presented at medical congresses in the U.S. and Europe.  Full two-year data from the VISTA-DME trial will be presented at upcoming medical conferences.  Two-year data from the similarly designed VIVID-DME trial are expected later in 2014.  Each of the VISTA-DME and the VIVID-DME trials is expected to continue as planned up to 148 weeks.

EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012.  EYLEA has also been approved in the European Union (EU) and other countries for use in wet AMD and Macular Edema following CRVO.  Regulatory submissions have also been made in the U.S. and the EU for EYLEA for the treatment of DME.  A regulatory submission has been made in the U.S. for EYLEA for the treatment of macular edema following Branch Retinal Vein Occlusion (BRVO).

Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.  Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.