Positive Ph II five-year alemtuzumab data presented by Genzyme

Genzyme, which is now a wholly-owned subsidiary of French drug major Sanofi-Aventis Group (Euronext: SAN) reported additional five-year patient data from its completed Phase II multiple sclerosis (MS) trial showing that nearly two-thirds of alemtuzumab treated patients remained free of clinically-active disease as much as four years after most patients received their last course of the investigational drug.

The data were presented at the American Academy of Neurology's 63rd Annual Meeting in Hawaii, and help reinforce Genzyme’s aspirations for the drug in MS, for which use it carries the trade name Lemtrada, and is pivotal to the contingent value right (CVR) deal that is part of Sanofi’s increased bid for the company agreed at $21.1 billion plus the CVR (The Pharma Letters passim).

The CAMMS223 Phase II trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to the approved MS therapy Rebif (high dose interferon beta-1a) in early, active, relapsing-remitting multiple sclerosis (RRMS) patients who had received no prior therapy. In the trial, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three times per week, every week for three years. The study included an extended phase for collection of long-term efficacy and safety data.