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Teriflunomide Successfully Reduces Relapses and is Well Tolerated in Multiple Sclerosis Patients
Date:10/15/2010

rogression for Teriflunomide 14mg

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the results from the two year phase III TEMSO study of teriflunomide, a novel oral disease modifier investigated for the treatment of relapsing multiple sclerosis (RMS). In this study, both doses of teriflunomide (7 and 14mg) significantly reduced annualized relapse rate (primary study endpoint) by 31% vs. placebo (p is less than or equal to 0.0005). The risk of disability progression (sustained for 12 weeks) was also significantly reduced by 30% for the 14mg dose (p=0.02) and numerically reduced by 24% for the 7mg dose (p=0.08). Both doses of teriflunomide were well tolerated with a similar number of patients reporting either treatment-emergent adverse events (TEAEs) including serious adverse events or TEAEs leading to treatment discontinuation in the treatment vs. placebo arms.

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"We are very pleased with the successful results of the TEMSO study which are an important step forward in multiple sclerosis clinical research," said Marc Cluzel, M.D., Ph.D., Executive Vice President, Research & Development, sanofi-aventis. "These exciting results with teriflunomide represent a new real hope to delivering an oral therapy to patients who live with this serious condition and are eager for new treatment options, and more convenient product forms in-line with our sanofi-aventis commitment to multiple sclerosis."

The results of the TEMSO trial are the first study findings from a large phase III clinical development program on teriflunomide. These results were presented today during the European Committee for Treatment and Research in M
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SOURCE Sanofi-aventis
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