Lemtrada alemtuzumab regulatory update

FDA accepted for review an sBLA from Sanofi's Genzyme Corp. subsidiary for Lemtrada alemtuzumab to treat relapsing multiple sclerosis. The PDUFA date is in 2H13, but the exact date is not disclosed. Last August, FDA refused to file the sBLA and asked Genzyme to "modify the presentation of the data sets to enable the agency to better navigate the application" (see BioCentury, Sept. 3, 2012). An MAA for Lemtrada is under review in Europe, with a decision from EMA's CHMP expected next quarter.

In 2011, Sanofi acquired Genzyme for about $20.1 billion, plus a $14 contingent value right. The CVR includes $1 for FDA approval of Lemtrada for MS and up to $12 upon the achievement of sales thresholds for the product (see BioCentury, Feb. 21, 2011). ...