NEW YORK (AP) – French drugmaker Sanofi said that its multiple sclerosis drug candidate Lemtrada did not achieve one of its goals in a late-stage clinical trial.
Sanofi said Lemtrada worked better than an older drug, Rebif, in preventing relapses, as patients treated with Lemtrada were 55 percent less likely to experience a relapse in symptoms. However, the drug did not prevent their multiple sclerosis from becoming disabling, as it had in previous studies.
Sanofi’s Genzyme unit and its partner Bayer HealthCare enrolled 851 patients who had not previously been treated for multiple sclerosis. The companies plan to report results from a second late-stage trial during the fourth quarter of 2011, and they plan to file for marketing approval in the U.S. and the European Union early next year.
Rebif is an older drug marketed by Merck KGaA of Germany.
Sanofi and Bayer said the most common side effects of Lemtrada treatment were headache, rash, fever, nausea, flushing, hives, and chills.
Lemtrada’s chemical name is alemtuzumab. The drug is marketed as a treatment for leukemia under the name Campath. Lemtrada was a sticking point in buyout discussions between Sanofi and Genzyme, and when Sanofi agreed to acquire Genzyme for $20.1 billion this year, it agreed to make an additional payment if Lemtrada is approved.
The second late-stage trial of Lemtrada will involve patients who relapsed during previous treatment.
Date: July 11, 2011
Source: Associated Press
Filed Under: Drug Discovery