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Bayer (BAYRY - Analyst Report) along with partner, Regeneron Pharmaceuticals Inc. (REGN - Analyst Report) recently announced positive 52-week data from the phase III VIVID-DME and VISTA-DME studies on VEGF Trap-Eye for the treatment of diabetic macular edema (DME).
The VIVID-DME and VISTA-DME phase III studies are evaluating the safety and efficacy of VEGF Trap-Eye in patients suffering from DME. Results from the studies showed that patients treated with VEGF Trap-Eye experienced significantly greater improvements in best-corrected visual acuity (BCVA) from baseline in comparison to laser photocoagulation.
Bayer mentioned in its press release that improvements in BCVA in both the studies were similar. The studies further revealed that the candidate was well tolerated with a comparable overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs. The studies are expected to continue up to 148 weeks.
The HealthCare segment at Bayer now intends to file a marketing application for VEGF Trap-Eye in Europe by the end of 2013 for the DME indication. Meanwhile, partner Regeneron also intends to do the same in the U.S. by year end, one year earlier than originally planned.
Bayer has a collaboration agreement with Regeneron for the global development of Eylea (U.S. trade name of VEGF Trap-Eye). Per the terms of the agreement, Regeneron owns the entire U.S. rights pertaining to the eye drug. Bayer is however responsible for marketing Eylea in ex-U.S. markets on approval. The profit earned from the sales of Eylea in those markets will be shared equally by the companies. However, in Japan, Regeneron will receive royalties on Eylea’s net sales.
Bayer recently received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on the EU approval of VEGF Trap-Eye for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). A final verdict from the European Commission on the approval of VEGF Trap-Eye in this indication is expected later this year.
We note that VEGF Trap-Eye is already approved in the U.S. for the CRVO indication since Sep 2012 under the trade name of Eylea. Eylea is also approved in the U.S. for the treatment of neovascular (wet) age-related macular degeneration (AMD).
We also note that Eylea is also approved in Europe, Japan, Australia and several other countries for the wet AMD indication. Bayer is also evaluating the eye-drug in the myopic choroidal neovascularization indication.
Eylea sales came in at €73 million in the second quarter of 2013 as per Bayer.
Bayer, a large cap pharma stock, presently carries a Zacks Rank #3 (Hold). However, another large cap pharma stock, Johnson & Johnson (JNJ - Analyst Report), currently looks better positioned with a Zacks Rank #2 (Buy).
Other companies in the pharma space that are worth considering include Biogen Idec Inc. (BIIB - Analyst Report), which carries a Zacks Rank #1 (Strong Buy).