Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals Neurology

 News Release - October 2, 2006

COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients

New Data from the Longest Prospective Study Employing Annual Magnetic Resonance Spectroscopy Imaging (MRS) Indicate Impact of COPAXONE(R) on Axonal Injury and Recovery

KANSAS CITY, Mo.--(HSMN NewsFeed)--Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that COPAXONE® (glatiramer acetate injection) may slow the neurodegenerative tissue damage that is a key aspect of multiple sclerosis (MS) disease pathology. Results of the longest, prospective study of annual brain proton MRS imaging in relapsing-remitting multiple sclerosis (RRMS) patients suggested a beneficial effect of COPAXONE® treatment on cerebral axonal injury and recovery.

"These data reinforce the findings of previous studies showing that in addition to reducing relapses in RRMS patients over the long term, COPAXONE® may have the unique ability to slow or prevent neurodegenerative processes by reducing axonal injury and promoting axonal recovery within the central nervous system, and that this benefit is sustained over time," said Omar Khan, M.D., Wayne State University and lead investigator of the study.

In MS, measuring brain n-acetylaspartate (NAA) levels relative to creatine (Cr) (NAA/Cr ratios) via MRS is a method of assessing axonal injury caused by the disease. Decreased levels of brain NAA/Cr ratios are a marker of neuronal damage or degeneration and also correlate strongly to clinical disability; an increase in brain NAA/Cr ratios indicates a recovery of injured nerve cells or neurons in the brain. This study involved annual blinded MRS analyses of NAA/Cr of patients (n=22), over four years.

"Patients in this study who remained on COPAXONE® (glatiramer acetate injection) experienced an increase in mean NAA/Cr, pointing not only to the treatment's effect on slowing accumulation of brain tissue damage as measured by MRS, but to its effect on the recovery of damaged brain tissue," said Khan. "Measuring changes in NAA/Cr ratio throughout the course of the disease is of increasing interest to the MS research community because of data demonstrating its correlation with accumulated disability, pointing to the potential for MRS imaging to serve as a surrogate marker for both disease progression and therapeutic response in clinical practice."

About the Study

In this study, investigators performed annual conventional magnetic resonance imaging (MRI) as well as MRS measurements on treatment-naive RRMS patients (n=22), 18 of whom commenced treatment with COPAXONE® and four who remained untreated by choice. Over the four years of the study, blinded annual MRS analyses of NAA/Cr were carried out in a volume-of-interest (VOI) centered on the entire corpus callosum, which also allowed for the examination of the normal appearing white matter (NAWM) within the corpus callosum. At baseline, patients' (n=18) mean NAA/Cr ratios (+/-SD) for the entire VOI was 1.97 (+/- 0.24) and was 2.075 (+/- 0.30) in the NAWM. After four years of follow up, 15 of the 18 patients in the treated group were still receiving COPAXONE® and demonstrated an increase to a mean NAA/Cr of 2.21 (+/- 0.16) in the VOI and 2.27 (+/- 0.20) in the NAWM.

About COPAXONE®

Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

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 management's current beliefs and 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 risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the reintroduction of Tysabri® into the 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, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, 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. 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.


Source: Teva Pharmaceutical

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