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

Neurology's 63rd Annual Meeting. Two pivotal Phase 3 studies investigating alemtuzumab, CARE-MS I and II, are currently ongoing. Top-line results from these trials are expected to be available early in the third quarter of 2011 and in the fourth quarter of 2011. The company expects to file for U.S. and EU approval in early 2012, and has been granted fast track status by the FDA.

Genzyme and Isis Pharmaceuticals Inc. announced in April that data from two phase 3 studies of mipomersen in patients who had high cholesterol levels while on lipid-lowering therapy were presented at the American College of Cardiology. In the study in patients with severe heterozygous familial hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36% compared with a 13% increase for placebo (p<0.001). Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in previous studies.

Results of a Phase 3 study of mipomersen in patients with high cholesterol at high risk for CHD were also presented in a poster at American College of Cardiology. In this study, mipomersen reduced LDL-C, the primary endpoint, by 37% compared with a 5% reduction for placebo (p<0.001). Genzyme expects to file for EU marketing approval of mipomersen for the treatment of patients with hoFH (homozygous familial hypercholesterolemia) and severe heFH (heterozygous familial hypercholesterolemia) early Q3 2011. Genzyme also expects to file for U.S. approval for the hoFH indication in second half of this year.

In March, sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced results from the Phase III VITAL trial evaluating aflibercept for the second-line treatment of non-small cell lung cancer. The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen
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