Sanofi MS drug shines, biotech strategy advances

Sanofi is seeing its increased focus on biotech drugs go according to plan, with positive results today from a late-stage trial of a multiple sclerosis treatment, Lemtrada, which the French drugmaker picked up through its $20 billion-plus buyout of biotech powerhouse Genzyme earlier this year.

The study was an overall success, according to Sanofi ($SNY). In the Phase III trial comparing Lemtrada (or alemtuzumab) to Merck KGaA's approved MS drug Rebif, patients on Lemtrada showed a 55% reduction in relapse rates over a two-year period, meeting the primary goal of the study. Yet the drug fell short on showing a statistically significant reduction in disability rates compared to Rebif, which was the second primary endpoint of the study.

Sanofi, whose Genzyme unit is developing Lemtrada for MS in partnership with Bayer Healthcare, can tout the results from this trial as it sells its non-core Dermik dermatology products business to Canadian drug company Valeant Pharmaceuticals $435 million in cash. The French pharma giant had previously revealed plans to sell off skin care products and ratchet up its focus on developing new treatments like Lemtrada.

"Our strategy is based upon our growth platforms and innovation," Sanofi CEO Christopher Viehbacher said in a statement in connection with the Dermik sale. "This divestiture allows us to rationalize our portfolio and improve focus on our core businesses."

Lemtrada still faces some tests en route to regulatory approval, for which Sanofi plans to file in the U.S. and European Union in early 2012. The late-stage trial in today's news, Care-MS I, tested the drug in patients with relapsing remitting forms of MS who had received no prior therapy. The company plans to reveal results from a trial dubbed Care-MS II in the fourth quarter of this year that recruited MS patients who had relapsed while on therapy, and success in that trial would help further distinguish Lemtrada as a potent new option for certain patients with the autoimmune disease.

"(Lemtrada) is relatively effective but we need to have more details on the side effects, which are key in MS drugs," Jean-Jacques Le Fur, an analyst at Oddo & Cie. in Paris, told Bloomberg this morning. "It's a bit surprising" that the study's second target wasn't reached, he said.

- here's Sanofi's release on Lemtrada
- read Bloomberg's report
- see what Reuters reported