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Investigational Oral Multiple Sclerosis Therapy Teriflunomide (Aubagio™(*)) Significantly Reduced Relapse Rate, Disability Progression and Disease Activity
Date:10/5/2011

PARIS, Oct. 5, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today the publication of the pivotal Phase III TEMSO study with investigational once-daily oral medication teriflunomide in The New England Journal of Medicine (NEJM).  Results showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions.  Teriflunomide has a well-characterized safety profile, with a similar proportion of trial participants reporting adverse events compared to placebo.

"The TEMSO data demonstrate the effect of teriflunomide in terms of reducing relapse rates, disability progression and Magnetic Resonance Imaging (MRI) lesions," said Dr. Paul O'Connor, Director of the MS Clinic at St Michael's Hospital, Toronto, Canada and principal investigator in the TEMSO study.  "These results, sustained over two years, provide clinically meaningful data for teriflunomide."

The two-year TEMSO (TEriflunomide Multiple Sclerosis Oral) trial involved 1,088 people with relapsing forms of MS from 126 centers across 21 countries. TEMSO is the first study from a broad clinical development program that includes more than 4,000 trial participants in 36 countries and is one of the largest and broadest clinical programs of any oral MS agent under development, with five Phase III clinical trials either completed or underway.

"The publication of the teriflunomide results in the New England Journal of Medicine is an exciting milestone as we continue the development of our product," said Dr. Elias Zerhouni, President, Global Research & Development, Sanofi. "As we continue our commitment t
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SOURCE Sanofi; Genzyme
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