FDA committees to discuss Lemtrada, tasimelteon

FDA's Peripheral and Central Nervous System Drugs Advisory Committee will meet on Nov. 13-14 to discuss Lemtrada alemtuzumab from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) and Hetlioz tasimelteon ( VEC-162) from Vanda Pharmaceuticals Inc. (NASDAQ:VNDA). On Nov. 13, the committee will discuss an sBLA for Lemtrada to treat relapsing multiple sclerosis (MS). The PDUFA date is in 4Q13, but the exact date is not disclosed. Sanofi acquired Genzyme in 2011 for about $20.1 billion plus a $14 contingent value right that includes $1 for FDA approval of the humanized mAb against CD52 and up to $12 upon the achievement of sales thresholds. The CVR, which trades on NASDAQ under the ticker symbol GCVRZ, was off $0.07 to $1.92 on Wednesday. The European Commission approved Lemtrada last month. ...