September 25, 2002
KANSAS CITY, MO
Copaxone® (glatiramer acetate injection) continues to show benefit after more than six years of treatment, according to a study published this month in the Journal of the Neurological Sciences. The study evaluated the short-term and long-term effects of Copaxone on the immune systems of people with relapsing-remitting MS to see if the disease-modifying immune activity noted in the first months of treatment were continued in patients treated with Copaxone for up to nine years.
"The sustained response to Copaxone remains based in inducing Th2 cells, the T-cells that can reduce the inflammation linked to relapses in MS. This study shows that both patients treated for only a few months as well as those treated for six to nine years show an increase in Copaxone-reactive Th2 cells," said Suhayl Dhib-Jalbut, M.D., University of Maryland School of Medicine, Baltimore.
The exact mode of action of Copaxone is not completely understood but this study and others that preceded it provide insight into how Copaxone affects the MS disease course. Researchers currently believe that Copaxone-activated T-cells cross the blood-brain barrier, cross-react with myelin antigens and consequently produce bystander suppression of inflammation through the secretion of anti-inflammatory cytokines. More simply, bystander suppression means that Copaxone, injected in the body, modifies the T-cells and allows them to enter the brain where the MS attack is occurring. The Copaxone (glatiramer acetate injection)-modified cells can then "tell" the cells attacking the myelin to stop, or down-regulate the inflammatory activity.
In relapsing-remitting MS, the body's immune system attacks the myelin proteins surrounding the nerves. Both the destruction of the myelin and the resulting inflammation cause the damage that occurs in people with MS. The goal of therapy is to stop or slow down the frequency of attacks, and the areas of damage occurring in the brain.
This study compared 10 relapsing-remitting patients treated for up to nine years as part of the pivotal Copaxone trial in the 1990s to 10 patients who were tested pretreatment and after one to 10 months of treatment with Copaxone. The findings confirm that the drug's disease-modifying activity continues, indicating that the immunological effects are sustained for more than six years.
The researchers believe further study on larger patient groups can help further understand the mechanism of action of Copaxone and provide insight into the correlation between immunologic effects and clinical outcomes.
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 40 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 35 pharmaceutical companies in the world. More than 80 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 Neuroscience, Inc., is a subsidiary of Teva Pharmaceutical Industries Ltd. Call 1-800/887-8100 or log onto http://www.copaxone.com for more information about Copaxone (glatiramer acetate injection) or multiple sclerosis. Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd. See additional important information at http://www.copaxone.com/pi or call 1-800/887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
This report contains forward-looking statements, which express the 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 the company'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 the impact of pharmaceutical industry regulation, the difficulty of predicting 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, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, 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, fluctuations in currency, exchange and interest rates, operating results, and other factors that are discussed in the company's annual report on Form 20-F and the company's other filings with the U.S. Securities and Exchange Commission.
SOURCE: Teva Neuroscience, Inc.
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