Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple... ( Three-Year Analysis Demonstrates Rob...)

Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple Sclerosis

Date:10/15/2007

Three-Year Analysis Demonstrates Robust, Highly Statistically Significant

Treatment Effect of Alemtuzumab Compared to Rebif(R)

CAMBRIDGE, Mass., Oct. 15 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) today announced that top-line, three-year data from a completed Phase 2 clinical trial comparing alemtuzumab with Rebif(R) (interferon beta- 1a) for the treatment of multiple sclerosis were presented this weekend at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague. The results come from an analysis conducted after 36 months of treatment for 334 patients in the three-year trial.

Results of the primary outcomes from this trial were presented by Alastair Compston, professor of neurology and the head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom, during the prestigious Charcot Award lecture at ECTRIMS.

Efficacy Results

Overall efficacy results demonstrate that alemtuzumab provides a significant treatment effect that has been found to last three years among patients in the study. Analysis of the first co-primary endpoint showed that patients taking alemtuzumab experienced at least a 73 percent reduction in the risk for relapse after three years of follow up when compared to patients treated with interferon beta-1a. This difference was highly statistically significant in favor of the alemtuzumab patients with a p-value less than the pre-specified value (p=0.00396) assigned for the three-year analysis.

Analysis of the other co-primary endpoint showed that patients taking alemtuzumab experienced at least a 70 percent reduction in the risk for progression of clinically
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SOURCE Genzyme Corporation
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