In a pilot study of 18 RRMS patients using brain imaging techniques, COPAXONE(R) was found to produce significant increases in n-acetylaspartate/creatine (NAA/Cr) ratio, an indicator of neuron and axon integrity, compared to four untreated control patients after one year of treatment. This increase was maintained at two years of follow-up. Additionally, patients treated with COPAXONE(R) showed a significant 50 percent reduction in relapses compared to baseline (p<0.001) while relapse rate in the untreated group remained unchanged.
"The increases in NAA/Cr ratios with COPAXONE(R) suggested sustained beneficial effects on cerebral axonal recovery. We believe this indicates a potential for improved electrical conduction pathways in the brain, supporting the emerging concept that, centrally, COPAXONE(R) may be acting as a neuroprotective agent," said Omar Khan, M.D., associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University. "This data is of critical significance because axonal transection is a well-known feature of active MS lesions and represents an irreversible stage of the disease process," said Dr. Khan.
Twenty-two treatment-naive RRMS patients were included in the study. Baseline neurological assessments and magnetic resonance spectroscopy imaging (MRSI) scans were performed. Eighteen patients were treated with COPAXONE(R) (glatiramer acetate injection) and followed for two years with neurological assessments every six months and MRSI scans annually. Due to needle phobia, four patients elected to remain untreated and were followed using the same assessment and MRSI schedule. NAA/Cr ratio measurements were obtained in a selected volume of interest (VOI) within the brain and included normal-appearing white matter (NAWM) within the VOI.
In the COPAXONE(R) group, the NAA/Cr levels within the VOI were significantly increased by 9.1 percent at year one and by 10.7 percent at year two, compared to baseline (p=0.03 for both assessments). Conversely, in the untreated group, a 5.5 percent decrease in NAA/Cr levels was observed in the VOI at year one (p=0.04) and an 8.9 percent decrease at year two (p=0.03). COPAXONE(R) patients also demonstrated a 5.4 percent and 7.1 percent increase in NAA/Cr ratios within the NAWM at years one and two, respectively (p=0.04 for both). Untreated patients had a two percent (p=n.s.) and 8.2 percent (p=0.03) decrease in NAA/Cr ratios within the NAWM at year one and two, respectively.
"We recognize our study contains limitations, such as the number of patients, open-label design, and the MRS technique of evaluating NAA levels," stated Dr. Khan. "However, our recently presented three-year data showed sustained improvements in NAA/Cr ratios which clearly demonstrated a long-term clinical benefit and showed that COPAXONE(R) treatment may lead to neuronal recovery," said Dr. Khan.
Current data suggest COPAXONE(R) (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE(R) is indicated for the reduction of the frequency of relapses in relapsing remitting multiple sclerosis. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE(R) Demonstrated Protection
COPAXONE(R) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience. Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system. Teva Pharmaceuticals USA and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE(R). COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.
See additional important information at 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 beliefs and expectations of Teva's 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 whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the Ivax acquisition, Teva's ability to rapidly integrate Ivax's operations and achieve expected synergies, 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 or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic version of Neurontin(R), the effects of competition on Copaxone(R) sales, 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 Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, 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.