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Sanofi's Lemtrada Helps MS Patients More Than Rebif In Phase III Trial

French drug major Sanofi and its U.S. subsidiary Genzyme said on Saturday that the experimental multiple sclerosis drug Lemtrada helped patients better than an existing drug in a late-stage trial.

New results from the CARE-MS I trial showed that 78 percent MS patients treated with Lemtrada remained relapse-free for two years compared with 59 percent who took the German rival Merck KGaA's Rebif. The study results were presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis held in Amsterdam.

The trial is the first of two randomized Phase III clinical trials comparing Lemtrada with Rebif. Preliminary results of the study, reported in July, showed that Lemtrada treatment resulted in a 55 percent reduction in relapse rate compared to Rebif. The results of the second study is expected to be available later this year.

Lemtrada, which is the the proprietary name alemtuzumab for relapsing MS, is being developed by Genzyme in collaboration with Bayer HealthCare. Sanofi plans to file for U.S. and E.U. approval for Lemtrada in the first quarter of 2012. The drug has been granted Fast Track designation by the U.S. Food and Drug Administration. On approval, Lemtrada is likely to face competition from Novartis AG's oral MS treatment Gilenya.

Genzyme is already marketing alemtuzumab for chronic lymphocytic leukemia under the brand name Campath. The company was acquired by Sanofi-aventis in April. During the acquisition, it was agreed that holders of the Genzyme contingent value rights certificates are entitled to receive additional cash payments if specified milestones related to Lemtrada are achieved.

by RTTNews Staff Writer

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