Positive Ph II five-year results with Genzyme's alemtuzumab in MS patients could prompt higher bid from Sanofi, observers suggest

US biotech major Genzyme Nasdaq: GEN), which is fending off an unsolicited takeover  bid from France’s Sanofi-Aventis (Euronext; SAN), has presented positive clinical trials data for its currently marketed chronic lymphocytic leukemia drug Campath (alemtuzumab) in the treatment of multiple sclerosis.

The commercial potential for the drug, if approved and marketed for the MS indication, has been an important factor in Sanofi-Aventis’ valuation of Genzyme, for which it is maintaining its $69 a share offer and arguing that the US firm has not disclosed information that could change its view. Sanofi-Aventis also presented new data for its own MS drug candidate teriflunomide (see separate story today).

Sales forecasts for alemtuzumab are very mixed, ranging from as little as $500 million a year from Cowen & Co analyst Phil Nadeau, market research group BioMedTracker predicting sales will reach $1.6 billion in 2019, and some analysts going as high as $2 billion, in a global market that Genzyme estimates will be worth around $13 billion by the end of this year. The MS indication is under co-development with German drug major Bayer (BAY. DE), although the latter has returned rights to alemtuzumab for other uses to Genzyme (The Pharma Letter April 1, 2009).

Sustained reduction in disability

Genzyme on Friday reported five-year patient data from its completed Phase II multiple sclerosis trial at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, in Sweden. This sub-group analysis found that nearly 90% of alemtuzumab-treated patients were free of sustained accumulation of disability, and that those receiving the drug also maintained improved mean disability scores and a low risk of relapse over the 60-month follow-up period. The majority of alemtuzumab patients received their last course of treatment at month 12 in the study.