Sanofi's MS-drug Alemtuzumab meets first primary goal
French drug maker Sanofi SA announced mixed results of a late-stage trial of multiple sclerosis drug Lemtrada. The two-year study CARE-MS I is the first of two randomised, Phase 3 clinical trials comparing Sanofi's alemtuzumab to Rebif. The CARE-MS I study incorporated 581 patients with relapsing-remitting multiple sclerosis who had not had prior treatment for their illness and showed that Lemtrada helped patients more than Rebif, Merck KGaA's established multiple sclerosis therapy. The product cut relapse rates by 55 percent over two years compared with Rebif Sanofi said in a statement on Monday. But Lemtrada failed on the second goal; statistically, it is not better than Rebif in helping stave off disability for the duration of the test. Sanofi's shares not unexpectedly fell after the announcement. Another Phase 3 clinical trial, CARE-MS II, is currently underway, evaluating Lemtrada against Rebif in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy. The medicine’s prospects were at the heart of the Genzyme takeover talks this year. Cambridge, Massachusetts-based Genzyme was projecting peak annual sales of as much as $3.5 billion, saying Lemtrada was likely to become its bestseller. Sanofi said in October that analysts’ estimates of about $700 million were a valuation “probably closer to the reality of the product.” Sanofi expects to file the drug for U.S. and European Union approval in multiple sclerosis in early 2012 and has been granted fast track designation by the U.S. FDA. Sanofi has time. Cash is not the problem. On Monday the French drugmaker revealed it was selling its Dermik dermatology business to Canada's Valeant Pharmaceuticals for $425 million.