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EC OKs Lemtrada, NICE wants Aubagio data

September 18, 2013 1:01 AM UTC

The European Commission approved Lemtrada alemtuzumab from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat relapsing remitting multiple sclerosis (RRMS) in patients with active disease defined by clinical or imaging features. The company plans to launch Lemtrada "soon." Last year, Genzyme withdrew MabCampath/ Campath alemtuzumab from the European and U.S. markets to treat B cell chronic lymphocytic leukemia (CLL) to prepare for commercialization of the drug for MS. An sBLA for the humanized mAb against CD52 is under review in the U.S. for relapsing MS, with a decision expected in late 2013.

Sanofi acquired Genzyme in 2011 for about $20.1 billion, plus a $14 contingent value right tied to milestones including Lemtrada sales. The CVR, which trades on NASDAQ under the ticker symbol GCVRZ, was up $0.12 to $1.96 on Tuesday. ...