The results of this study, entitled "Randomized, double-blind, dose-comparison of glatiramer acetate in relapsing-remitting MS," were published in a recent issue of Neurology. The study can be accessed at: http://www.neurology.org/cgi/content/abstract/68/12/939.
"COPAXONE(R) is an established RRMS therapy with more than 12 years of clinical research and experience supporting its efficacy and safety. The recently published data demonstrated that a 40 mg dose was well tolerated, with a safety profile similar to the currently available 20 mg dose," said Jeffrey A. Cohen, M.D., Director of the Experimental Therapeutics Program at Cleveland Clinic's Mellen Center for MS Treatment and Research and Coordinating Principal Investigator of the study. "In addition, the results suggested that a 40 mg dose of COPAXONE(R) may provide better control of disease activity, and justify additional research on the therapeutic effect of higher dosages of this drug."
Based upon the results of this study, a large-scale Phase III study designed to confirm the higher efficacy of COPAXONE(R) with the increased dose has been initiated. The study, entitled FORTE (FORTy mg Efficacy of glatiramer acetate), was launched July, 2006, in 137 centers across North America, Europe, Argentina and Israel. Recruitment of approximately 1,000 patients is expected to be completed in May 2007. These dossiers, including these data, are expected to be submitted to the U.S. Food and Drug Administration in 2008.
Phase II Study Design and Results
The study was a randomized, double-blind, parallel-group study conducted at 18 centers in the U.S. in 90 patients with RRMS. The study evaluated the effect of 40 mg of COPAXONE(R) (glatiramer acetate injection) given daily versus 20 mg of COPAXONE(R) on disease activity as measured by MRI and clinical relapses, as well as the safety and tolerability of the 40 mg dose over a period of 9 months. Patients that qualified for this study had clinically-definite MS, had experienced a relapse in the previous year, had at least one Gd-enhancing lesion at screening visit, and had a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5. Patients were randomized in equal numbers to receive either 40 mg or 20 mg of COPAXONE(R). All patients underwent an MRI at baseline, and then at months 3, 7, 8 and 9. Neurological examinations were performed at screening, baseline, and again at months 3, 6 and 9, and suspected on-trial relapses were confirmed at an unscheduled visit within 7 days.
COPAXONE(R) 40 mg showed a 38 percent greater reduction of inflammatory disease activity as measured by mean cumulative number of Gd-enhancing T1 MRI lesions versus COPAXONE(R) 20 mg (p=0.0898). The benefit of the 40 mg dose was observed in as soon as 3 months (p=0.005) through MRI measurement. When compared to baseline numbers, the risk of having MRI activity (Gd-enhancement) in the 40 mg group at months 7, 8 and 9 was reduced by 75 percent (p<0.0001), compared to 65 percent in patients receiving the 20 mg dose (p<0.0001).
Relapse rates were also lower in patients who received the 40 mg dose of COPAXONE(R), when compared to those who received 20 mg dose (0.34 versus 0.57, respectively). Patients on 40 mg dose of COPAXONE(R) experienced a reduced on-trial mean relapse rate of 77 percent when compared to the annual relapse rate prior to entry, versus patients who received the 20 mg dose (62 percent reduction). The time to the first relapse was significantly delayed from 80 days in the 20 mg group to 213 days in the 40 mg group (p = 0.0367). The overall safety profile was similar to that of the 20 mg dose. Some features of injection site reactions and immediate post-injection reactions were more common.
About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that 400,000 people in the United States are affected by this disease, and that over two million people are affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves.
Patients with MS may experience physical symptoms and/or cognitive impairments, including weakness, fatigue, ataxia, physical dysfunction, bladder and bowel problems, sensory effects, and visual impairment. MS also has a significant impact on the sufferers' social functioning and overall quality of life.
COPAXONE(R) is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE(R) is now approved in 47 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 phar maceutical 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. Close to 90 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
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Jeffrey Cohen, M.D., is a member of Teva's Scientific Advisory Board.
Teva Pharmaceutical Industries Ltd.
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President and CEO
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