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Sanofi MS drug Lemtrada misses a goal in study

Sanofi MS drug Lemtrada misses a goal in study

French drugmaker Sanofi said Monday 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, similar numbers of patients saw their disability get worse. The company said 8 percent of the patients on Lemtrada had their disability get worse, compared to 11 percent of the Rebif patients. The difference was not statistically significant.
U.S. shares of Sanofi fell $1.33, or 3.3 percent, to $38.44 in afternoon trading.
Sanofi's Genzyme unit and its partner Bayer HealthCare enrolled 581 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.


Updated : 2021-05-06 16:00 GMT+08:00