Regeneron/Bayer’s Eylea Gets Label Expansion in Japan

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Regeneron Pharmaceuticals, Inc. REGN announced that Bayer’s BAYRY Japanese subsidiary, Bayer Yakuhin, Ltd. gained approval for Eylea for yet another indication in Japan. Eylea was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients suffering from macular edema secondary to retinal vein occlusion (RVO).

We note that Regeneron co-developed Eylea with the HealthCare unit of Bayer. Regeneron is solely responsible for U.S. sales of the eye drug and is entitled to the entire share of profits made in the country, while Bayer is responsible for sales internationally. Regeneron and Bayer have agreed to equally share the profits (or losses) from ex-U.S. Eylea sales, except for Japan, where Regeneron receives a percentage on net sales.

We remind investors Eylea is already approved in the U.S. for the treatment of diabetic retinopathy in patients suffering from diabetic macular edema (DME), wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and DME.

We note that Eylea is the key growth driver at Regeneron. We are encouraged by the label expansion of Eylea as it will boost sales further. We expect investor focus to remain on updates regarding Eylea.

Bayer carries a Zacks Rank #2 (Buy), while Regeneron carries a Zacks Rank #3 (Hold). Other well-ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Acorda Therapeutics, Inc. ACOR. While Valeant holds a Zacks Rank #1 (Strong Buy), Acorda carries the same Zacks Rank as Bayer.

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