More MS news articles for Oct 2001

Teva Announces That Health Canada has Approved Enhanced Labeling for COPAXONE

http://news.excite.com/news/bw/011010/teva-pharmaceutical

Wed, Oct 10 1:19 PM EDT

JERUSALEM, Israel (BUSINESS WIRE) - Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced today that Health Canada has approved enhanced labeling for its multiple sclerosis drug COPAXONE(R) (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(R). Physicians increasingly use MRI for their diagnosis and treatment of MS.

Treatment with COPAXONE(R) 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(R) 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(R). 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(R) 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(R) the fastest growing MS therapy in North America."

Copaxone(R) 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(R). The drug was launched the same year. COPAXONE(R) 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(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 40 pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

Safe Harbor Statement: This report contains forward-looking statements, which express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward looking statements. Important factors that could cause or contribute to such differences include the impact of pharmaceutical industry regulation, the difficulty of predicting FDA and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products,uncertainties regarding market acceptance of innovative products newly launched,currently being sold or in development,the impact of restructuring of clients,reliance on strategic alliances, fluctuations in currency,exchange and interest rates,operating results,and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S.Securities and Exchange Commission.