Bayer Looking to Expand Eylea's Label

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The HealthCare segment at Bayer (BAYRY) announced that it has submitted a Marketing Authorisation Application for Eylea (aflibercept solution) for the treatment of patients suffering from visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO).

The EU 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 17.0 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 already submitted in the U.S. for the BRVO indication. A final decision from the FDA on the approval of Eylea is expected by Oct 23, 2014.

Eylea, a key product at the HealthCare segment, has put up an impressive performance since its launch in late 2011 for the neovascular (wet) age-related macular degeneration (AMD) indication. Eylea is also approved for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion in several countries.

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.

Eylea was also sought for the diabetic macular edema (:DME) indication in the U.S. A final decision on the approval of the drug in the DME indication is expected by Aug 18, 2014. The drug is also under review in the EU for the same indication.

Eylea contributed €157 million in the first quarter of 2014. Further label expansion of the drug will boost sales. We are encouraged by the way Bayer’s newly launched products have performed so far. Eylea along with other new products like Xarelto (anticoagulant), Stivarga (oncology), Xofigo (oncology) and Adempas (pulmonary hypertension) posted sales of €598 million in the first quarter and are expected to contribute around €2.8 billion in 2014.

Bayer presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Allergan Inc. (AGN) and Alexion Pharmaceuticals, Inc. (ALXN). While Allergan carries a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).

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