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|December 03, 2007 2:14 p.m.|
|Early Treatment with COPAXONE® Demonstrated Robust Protection against Progression to Clinically Definite Multiple Sclerosis in the PreCISe Study|
Efficacy Is Attained and the Study Is Stopped after Interim Analysis and Supports Filing of COPAXONE® For Patients with a First Clinical Event Suggestive of MS
Jerusalem, Israel, December 3, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced the positive results from a pre planned interim analysis of the PreCISe trial in patients presenting with a first clinical event and MRI features suggestive of multiple sclerosis (MS). The results showed that treatment with COPAXONE® (glatiramer acetate injection) reduced the risk of developing clinically definite MS (CDMS) by 44 percent versus placebo, and prolonged the quartile time to disease conversion to 722 days versus 336 days (+386 days, +115%) in those patients receiving placebo (hazard ratio 0.56, p=0.0005). At the time of the interim analysis, the proportion of patients who had developed CDMS was reduced from 43 percent in the placebo group to only 25 percent in the COPAXONE® group. Based on these results, Teva plans to file a request for marketing authorization of COPAXONE® in Europe, the U.S. and Canada for the treatment of patients with a first clinical event suggestive of MS.