EC approves Regeneron’s EYLEA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc.Nov 27 2012

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA^®  (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).  According to the European Medicines Agency (EMA) approved Summary of Product Characteristics, EYLEA treatment is initiated with one 2 milligram (mg) injection per month for three consecutive months, followed by one injection every two months.  There is no requirement for monitoring by the physician between injections.  After the first twelve months of treatment with EYLEA, the treatment interval may be extended based on visual and anatomic outcomes.  In such cases, the frequency of monitoring visits is determined by the treating physician and may be more often than the schedule of injections.  

"We are pleased with the approval of EYLEA in the E.U.," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We, along with our partner, Bayer HealthCare, look forward to providing this new treatment option which will allow for every other month dosing, following three initial monthly injections, to wet AMD patients in the European Union."

EYLEA was approved for the treatment of neovascular (wet) AMD in the United States in November 2011 and in Japan, Australia, Switzerland, and other countries this year.  Bayer HealthCare plans to launch EYLEA in these countries later in 2012 and into 2013.  In the United States, EYLEA was also approved for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. 

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