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Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple Sclerosis
Date:10/15/2007

significant disability when compared to patients treated with interferon beta-1a. This difference was statistically significant in favor of the alemtuzumab patients with a p-value less than the pre-specified value (p=0.01646) assigned for the three-year analysis.

Results for the secondary endpoints support the findings seen in the co- primary endpoints. Full, detailed efficacy and safety data from the study are expected to be presented at the 60th Annual Meeting of the American Academy of Neurology next spring.

"These results demonstrate the durability of the previously reported effect of alemtuzumab for the treatment of multiple sclerosis that, by our analysis, exceeds any current marketed products and anything that we can see in development," said Richard A. Moscicki, MD, chief medical officer for Genzyme. "We are very impressed with the consistency of these data and feel that they continue to point to the strong likelihood of alemtuzumab being approved for MS patients."

Safety Data: No New Cases of ITP

A total of six patients have been diagnosed with ITP associated with Grade 3 or 4 thrombocytopenia in this trial and there have been no new cases of ITP reported in the past year in this study.

Common non-serious adverse events included infusion reactions in the alemtuzumab patients and flu-like symptoms in patients using interferon beta- 1a. Severe infections were infrequent in the alemtuzumab patients and were resolved with or without an intervention. The incidence of all thyroid adverse events, including Graves' disease, was less than expected compared to early reports in the literature on the use of alemtuzumab in MS.

Two Phase 3 studies have recently begun examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis. Genzyme and Bayer Schering Pharma AG, Germany announced last month the start of the CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized
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SOURCE Genzyme Corporation
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