Teva Pharmaceutical announces clinical study results of Copaxone in RRMS patients

Feb 26 2010

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced the publication of data from the 15-year clinical study with Copaxone^® (glatiramer acetate injection), which is the longest prospective and continuous evaluation ever conducted in relapsing-remitting multiple sclerosis (RRMS) patients. The data were published in the February issue of the journal Multiple Sclerosis.

“Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15-Year Analysis of the U.S. Prospective Open-label Study of Glatiramer Acetate”

The 15-year clinical study demonstrated that more than 80 percent of patients were still walking without assistance despite a mean MS disease duration of 22 years, and two-thirds of patients have not transitioned to secondary progressive MS. Patients who remained in the study over a mean of 15 years showed a reduction in annualized relapse rate (ARR) from baseline as well as minimal increase in Expanded Disability Status Scale (EDSS). On average, the ARR in the ongoing cohort declined from 1.12 ± 0.82 to 0.25 ± 0.34 at the 15-year analysis.

Additionally, the study reinforces the established long-term safety profile associated with Copaxone^®. The most common adverse events associated with Copaxone^® were local injection-site reactions and immediate post-injection reactions. No other immune-mediated disorders, infections or malignancies were reported.

“This study is important for the MS community as it further confirms the benefits of continuous long-term use of Copaxone^® and its ability to effectively slow the natural progression of this disease,” said Corey Ford, M.D., Ph.D., primary investigator in the study and Professor of Neurology, Director of the Multiple Sclerosis Specialty Clinic and Assistant Dean for Research at the University of New Mexico Health Sciences Center. “It is encouraging to see such long-term results that further support the well-established benefit-to-risk profile of this treatment relevant to a life-long disease.”

"We are pleased to see that results from this study reinforce the long term efficacy and safety of Copaxone^®,” said Moshe Manor, Teva's Group Vice President, Global Branded Products. “The longest term study extension further demonstrates Teva’s investment in Copaxone^® and our ongoing commitment to improve the disease course of MS."

This study represents the only prospective, open-label follow-up study designed to evaluate continuous immunomodulatory therapy in RRMS patients. The study, currently in its 19^th year, was extended to 20 years based on the positive results seen thus far and the interest of the MS community in the long term outcomes of treatments for this life-long disease.