Jerusalem, Israel, October 10, 2001 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that Health Canada has approved enhanced labeling for its multiple sclerosis drug COPAXONE® (glatiramer acetate for injection). The new label reflects the positive result of a large multicenter, double-blind, placebo-controlled study that showed a significant reduction of MRI gadolinium-enhancing lesions (new active lesions) in patients treated with COPAXONE®. Physicians increasingly use MRI for their diagnosis and treatment of MS.
Treatment with COPAXONE® showed a significant reduction in T1 enhancing lesions as compared with placebo. T1 enhancing lesions are a sign of inflammation and blood brain barrier disruption. In addition, a statistically significant reduction in the mean number of relapses was observed within the initial 9-month observation period.
"We are excited to have the MRI research added to the COPAXONE® label because it gives physicians important additional information to consider when selecting an MS drug therapy," said Dr. Jean Godin, Medical Director of Teva Neuroscience in Canada.
The study followed 239 patients performing monthly MRI (magnetic resonance imaging) scans for nine months with an additional nine-month follow-up in which all patients were treated with COPAXONE®. The study looked at various MRI measures of disease activity and burden of disease The primary outcome measure was the total number of enhancing lesions on T1-weighted images over the nine months. The study was presented in a number of international scientific meetings and was recently published in Annals of Neurology. The link between MRI findings and the clinical status of patients is contentious and the prognostic value of changes in MRI findings is unknown.
"Teva Neuroscience is dedicated to improving the lives of people with MS through continued research. The expanded labeling further communicates the established positive impact of Copaxone® on patients with relapsing remitting multiple sclerosis", said Teva Neuroscience (Canada) General Manager John Hassler and added "This new label data will add to the research information that has made COPAXONE® the fastest growing MS therapy in North America."
Copaxone® is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis (RRMS).Teva Neuroscience was granted approval by Health Canada in 1997 to market COPAXONE®. The drug was launched the same year. COPAXONE® is marketed in Canada by Teva Neuroscience G.P.-S.E.N.C., based in Montreal, Quebec, a subsidiary of Teva Pharmaceutical Industries, Ltd.
COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
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