Regeneron gains on Eylea guidance

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) jumped $12.57 (12%) to $114.65 on Monday after raising its 2012 U.S. sales guidance for wet age-related macular degeneration (AMD) therapy Eylea aflibercept to $250-$300 million from $140-$160 million. Regeneron made the change after data from the first six weeks of 2012 showed "favorable" reimbursement trends for Eylea and an increase in weekly demand for the drug compared to the last six weeks in 2011. Eylea had net sales of $24.8 million from its launch in late November to Dec. 31 (see BioCentury Extra, Jan. 10).

Regeneron also said FDA accepted for review an sBLA for Eylea to treat central retinal vein occlusion. The PDUFA date is Sept. 23. Partner Bayer AG (Xetra:BAYN) plans to submit a similar regulatory application outside the U.S. in 2012 or early 2013. Bayer has ex-U.S. commercialization rights to Eylea from Regeneron, which retains exclusive U.S. rights. Bayer has submitted regulatory applications for Eylea in wet AMD in the EU and Japan. ...