Bayer’s (BAYRY) has progressed well with its newly launched products in the last few quarters. Drugs like Eylea (Eye), Stivarga (oncology), Xarelto (anticoagulant), 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. The company is looking to get these products approved for additional indications as well.
Last week, Bayer and Regeneron Pharmaceuticals Inc (REGN), announced encouraging two-year results from the phase III VIVID-DME study on Eylea (aflibercept solution). Eylea is being evaluated for the treatment of vision impairment due to diabetic macular edema (DME).
Results revealed that patients treated with Eylea (dosed monthly or every two months) showed sustained improvement in best corrected visual acuity from baseline compared to those under laser photocoagulation at 100th week. Moreover, Eylea was generally well tolerated during the study. The VIVID-DME study is expected to continue up to 148 weeks.
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Eylea is already under review in the U.S., Europe, Japan, Asia Pacific and Latin America for the DME indication. A final decision on the approval of the drug in the DME indication in the U.S. is expected by Aug 18, 2014.
The collaboration agreement between Bayer and Regeneron was inked in 2011 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 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 receives royalties on Eylea’s net sales.
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Bayer and Regeneron are also looking to get Eylea approved for the treatment of patients suffering from visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO). Eylea is submitted both in the U.S. and EU for the BRVO indication. A final decision from the FDA on the approval of Eylea in the BRVO indication is expected by Oct 23, 2014.
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