KANSAS City, Mo. and Jerusalem, Israel, October 1, 2001 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that a study published in the August issue of Neurology showed that COPAXONE® (glatiramer acetate for injection) reduced by 50% the percentage of permanent "black holes" that developed in patients with relapsing-remitting multiple sclerosis. Black holes are lesions MS can cause in the brain, and these lesions, if permanent, represent areas where the most severe and irreversible brain tissue damage has occurred.
"This study was designed to determine if glatiramer acetate could modify the severity of tissue damage in the lesions of MS patients. We know that permanent black holes represent areas with most severe brain damage. The study showed that the drug has the potential to prevent some of the delayed tissue destruction that can follow newly enhanced lesions," said Jerry S. Wolinsky, M.D., director of the MS Research Group at the University of Texas-Health Science Center.
The study evaluated 1,722 new lesions from 239 (119 COPAXONE®, 120 placebo) MS patients enrolled in the placebo-controlled MRI trial with COPAXONE® Investigators monitored these patients with monthly cerebral MRI scans. These scans measured the numbers and sizes of several types of lesions in the brain.
On subsequent monthly scans, researchers evaluated serial changes in tissues that follow the formation of new enhanced lesions. "The percentage of black holes on the follow-up scans was lower in COPAXONE®-treated patients than in placebo after seven months of follow up", concluded Massimo Filippi, M.D., Head of the Neuroimaging Research Unit, Department of Neuroscience, Scientific Institute and the University Ospedale San Raffaele, Milan, Italy. At month seven, the percentage of lesions that persisted as black holes was 18.9 percent for patients treated with COPAXONE® (glatiramer acetate for injection) and 26.3 percent for placebo, p=0.04. At month eight, the percentage was 15.6 percent for COPAXONE®-treated patients and 31.4 percent for placebo, p=0.002.
COPAXONE® is indicated for the reduction of relapses in relapsing-remitting MS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Patients should tell their doctor about any side effects.
Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.
COPAXONE® is marketed in the United States by Teva Neuroscience, based in Kansas City, Mo., a subsidiary of Teva Pharmaceutical Industries Ltd.
For more information about multiple sclerosis please visit Teva Neuroscience web site at: http://www.copaxone.com.
To receive prescribing information, call 800-887-8100, or visit the COPAXONE web site at http://www.copaxone.com.
COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd. (NASDQ: TEVA), headquartered in Israel, is among the top 40 pharmaceutical companies. 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 under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current 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 Teva'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 Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration ("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, 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, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.