Regeneron Pharmaceuticals Inc (REGN)

[surf1944]

4:15AM Regeneron Pharms receives approval for EYLEA Injection for the Treatment of Wet Age-Related Macular Degeneration in Japan (REGN) 151.20 : Co announces that EYLEA Injection has received approval for the treatment of patients with neovascular age-related macular degeneration from the Japanese Ministry of Health, Labour and Welfare. The MHLW approval of EYLEA is based upon the results of two Phase 3 clinical studies which demonstrated that EYLEA dosed every other month, following three initial monthly doses was clinically equivalent to Lucentis dosed every four weeks, as measured by the proportion of patients who maintained visual acuity over 52 weeks, the primary endpoint of both studies. The most common adverse reactions (5.0% or more) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, vitreous detachment, cataract, vitreous floaters, and increased intraocular pressure. Bayer (BAYRY) 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 any future sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales. In Japan, Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, has entered into a co-promotion agreement for EYLEA, with Santen Pharmaceutical.