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sanofi-aventis: Strong Performance of Growth Platforms in Q1 2011
Date:4/28/2011

rther newsflow from R&D is expected with Phase III studies to be completed/reported for five compounds (lixisenatide, alemtuzumab, teriflunomide, aflibercept, and semuloparin).

Evolution of the late stage portfolio:

In April, sanofi-aventis announced the top line results of GETGOAL-S, one of nine studies in the GetGoal Phase III clinical program. This study investigated the efficacy and safety of lixisenatide once-daily (partnership with Zealand Pharma) as an add-on therapy for people with Type 2 diabetes whose condition was inadequately controlled by sulfonylureas, with or without metformin. Top-line results of the GetGoal-S study showed that people in the lixisenatide group experienced a significant reduction in their HbA1c levels, with a -0.74% difference versus placebo at week 24. Lixisenatide also significantly improved patients' 2-hour post-prandial glucose and fasting plasma glucose levels. In addition, people treated with lixisenatide had a significant decrease in body weight, versus those receiving placebo. The full study findings are planned to be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting, in September 2011. Four positive Phase III studies of the GETGOAL clinical trial program (GETGOAL MONO, GETGOAL L-ASIA, GETGOAL-X and GETGOAL-S) have now been released and all met their primary endpoint with a favorable efficacy and safety profile of lixisenatide in patients with type 2 diabetes. Most of the remaining studies of the GETGOAL program are expected to be completed by the end of 2011.

In April, Genzyme (a new subsidiary of sanofi-aventis), reported additional five-year data from its completed Phase 2 multiple sclerosis trial showing that nearly two-thirds of alemtuzumab treated patients remained free of clinically-active disease as much as four years after most patients received their last course of the investigational drug. The data were presented at the American Academy of
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