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Sanofi: Sales Growth of 6.9% Thanks to Genzyme Acquisition and Performance of Growth Platforms
Date:7/28/2011

-MS I trial, two annual cycles of alemtuzumab treatment resulted in a 55 percent reduction in relapse rate compared to Rebif® over the two years of the study (p<0.0001), hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success. Statistical significance was not achieved for the second primary endpoint, time to six month sustained accumulation of disability, as compared to Rebif®. At the two year time point, 8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared to 11 percent of those who received Rebif® (Hazard Ratio=0.70, p=0.22). The safety profile was consistent with the Phase II clinical trial experience.

A second Phase III clinical trial, CARE-MS II, is currently underway, evaluating alemtuzumab against Rebif® in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy. Top-line results from this trial are expected in the fourth quarter of 2011.

In July, Sanofi and Regeneron announced results from Phase IIb trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab (REGN88/SAR153191), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R). The Phase IIb MOBILITY trial in rheumatoid arthritis demonstrated at 12 weeks that patients treated with sarilumab in combination with a standard RA treatment, methotrexate, achieved a significant and clinically meaningful improvement in signs and symptoms of moderate-to-severe RA compared to patients treated with methotrexate alone. In the Phase IIb ALIGN trial in ankylosing spondylitis (AS), sarilumab did not demonstrate significant and clinically meaningful improvements in signs and symptoms of active AS compared to placebo in patients who had inadequate response to NSAIDs (nonsteroidal anti-inflamma
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