Two Studies Demonstrate Sustained Efficacy and Safety With Copaxone®
September 22, 2003
Source: Teva Neuroscience
Data from long-term studies recently presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Milan, Italy, demonstrated that long-term treatment with Copaxone® (glatiramer acetate injection) significantly reduces relapse rates and slows accumulation of disability for people with relapsing-remitting multiple sclerosis (RRMS). The two studies, conducted in North America and in Argentina, followed patients for up to 10 and seven year periods, respectively, showing similar results in terms of long-term efficacy and safety.
"In a chronic disease such as multiple sclerosis, it is important to know that the drug the patient takes works over the long run. In both of these studies, one of them ongoing for more than a decade, Copaxone® continued to reduce relapses and accumulated disability," said Corey C. Ford, M.D., director of the Multiple Sclerosis Specialty Clinic of New Mexico, University of New Mexico, Albuquerque, New Mexico.
The U.S. pivotal study of Copaxone® enrolled 251 RRMS patients for up to 35 months in a randomized, double-blind, placebo-controlled trial. At the end of the double-blind portion of the trial, placebo patients were crossed over to Copaxone®, and a prospective, open-label study was initiated. Out of the 208 patients who entered the study, 133 initiated their 10th year. Of the 133 patients, 64 were originally randomized to Copaxone® and the remaining 69 to placebo. Now in its 12th year, the study is the longest, continuous, prospective investigation ever undertaken in MS.
Annual relapse rates during the 10th year were 0.22 for patients originally randomized to Copaxone® (glatiramer acetate injection) and 0.23 for patients initially randomized to placebo, representing a reduction from pretreatment rates of 1.52 and 1.46, respectively. During this time, the majority of patients on Copaxone® from the outset (64.4 percent) remained stable or improved in terms of accumulated disability as measured by Expanded Disability Status Scale (EDSS) scores.
An Argentinean study that followed 174 patients in a multi-center, observational study for up to seven years (average follow-up time was 3.8 years) showed similar results. Annual relapse rate was significantly reduced to 0.24 on Copaxone® compared to 0.89 pretreatment, and 59.8 percent of patients always on Copaxone® remained relapse-free. The majority of patients (65.9 percent) showed no change in their EDSS scores during treatment.
In both studies, Copaxone® was well-tolerated and no unexpected adverse effects were seen. Commenting on the importance of these results, Dr. Ford said, "Copaxone® continues to be effective and safe after a decade of use in RRMS patients. Sustained clinical benefit was seen in terms of relapse rate and accumulated disability."
Copaxone® is indicated for the reduction of the frequency 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, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
Copaxone® is now approved in 42 countries worldwide, including the U.S., Canada, Australia, Israel, and all the European countries. In Europe, Copaxone® is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, Copaxone® is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 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 is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets Copaxone® (glatiramer acetate injection).
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.
Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
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.
Copyright © 2003, PR Newswire Association LLC.