Bayer’s (BAYRY) HealthCare segment has been performing very well with the addition of products like Xarelto (anticoagulant), Eylea (eye drug), Xofigo (oncology), Adempas (pulmonary hypertension) and Stivarga (oncology). These new products are expected to contribute around €2.8 billion to segmental sales in 2014. The company is also looking to expand their label beyond current indications.
Last week, Bayer announced that it has submitted a Marketing Authorisation Application for Eylea in Japan for the treatment of patients suffering from macular edema secondary to branch retinal vein occlusion (BRVO).
The Japanese submission for the BRVO indication was based on encouraging results from the phase III VIBRANT study on Eylea. Results from the study revealed that 53% of the patients receiving Eylea (2 mg monthly) gained a minimum of 15 letters (3 lines) in best corrected visual acuity (BCVA) from baseline, compared to 27% of the patients receiving laser, at week 24. Patients treated with Eylea also showed a 17 letter mean improvement in BCVA from baseline in comparison to a 6.9 letter mean improvement in patients under laser treatment. Moreover, Eylea was well tolerated during the study.
Eylea is also submitted in the U.S. and EU for the BRVO indication. A final decision on the approval of the drug in the U.S. for the above indication is expected by Oct 23, 2014. The drug is already approved in Japan for the treatment of patients suffering from neovascular age-related macular degeneration (wet AMD) and the treatment of macular edema secondary to central retinal vein occlusion (CRVO). Bayer is also looking to get the drug approved in Japan for the diabetic macular edema and myopic choroidal neovascularization indications.
Bayer has a collaboration agreement with Regeneron Pharmaceuticals Inc. (REGN) for the global development of Eylea. 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. The profit earned from the sales of Eylea in those markets is shared equally by the companies. However, in Japan, Regeneron will receive royalties on Eylea’s net sales.
We are encouraged by Bayer’s progress with Eylea. Bayer recorded Eylea sales of €194 million in the second quarter of 2014. We expect the product to continue performing well.
Bayer presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Allergan Inc. (AGN) and Gilead Sciences Inc. (GILD). Both the stocks sport a Zacks Rank #1 (Strong Buy).
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