Teva's COPAXONE Meets Efficacy Endpoint In PreCISe Study In Multiple Sclerosis Patients - Quick Facts [TEVA]
12/3/2007 9:46:42 AM Teva Pharmaceutical Industries Ltd. (TEVA) 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 or MS.
The results showed that treatment with COPAXONE (glatiramer acetate injection) reduced the risk of developing clinically definite MS (CDMS) by 44% 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).
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.
The study's independent data monitoring committee recommended that the placebo arm of the trial be stopped, as COPAXONE successfully met the efficacy endpoint of the study. Data monitoring committee said that all placebo patients will now be given the opportunity to receive active treatment with COPAXONE for two years.
http://www.rttnews.com/sp/Quickfactsnew.asp?date=12/03/2007&item=95

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