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Multiple Sclerosis Drug, Copaxone (Glatiramer Acetate), Does Not Generate Neutralizing Antibodies

Of the Immunomodulating Therapies for Relapsing-Remitting Multiple Sclerosis, Copaxone Is the Only Therapy Proven Not to Develop Antibodies That Could Affect Efficacy

KANSAS CITY, MO -- March 27, 2003 -- Three studies of CopaxoneŽ (glatiramer acetate injection) showed the immunomodulating treatment for relapsing-remitting multiple sclerosis (MS) produced antibodies with no impact on its treatment effect.

Most people with relapsing-remitting MS develop the disease in their late 20s or early 30s. As a chronic disease, people can expect to require treatment for decades. Therefore, researchers have been reviewing studies to determine if any of the immunomodulating drugs developed neutralizing antibodies that would affect the drug's efficacy. Of the different types of antibodies seen with the immunomodulating drugs, some are binding, while others are neutralizing.

Neutralizing antibodies in the three interferon-beta treatments currently approved in the United States were the subject of an article in the Journal of Neurology, Neurosurgery and Psychiatry 2002:73:148-153, Bertolotto, et al. The article concluded that, "Neutralizing antibodies can appear early during the course of MS treatment, persist for several years before disappearing, decrease interferon-beta bioavailability, and reduce or abolish the clinical efficacy of interferon-beta."

Copaxone (glatiramer acetate injection) is a different approach to the treatment of MS. In a paper published in the Journal of Neuroimmunology 2001:115(1-2)152-160, Brenner, et al., looked at three studies on Copaxone to determine if the antibodies produced during treatment impacted clinical efficacy. The three studies were the Bornstein, et al., pilot trial in 1987, Johnson, et al., pivotal trial in 1995, and the Meiner et al., long-term safety study in 1997.

"The study concluded all patients treated with Copaxone developed glatiramer acetate-reactive antibodies. These antibodies were not found to be neutralizing and did not interfere with the ability of the drug to work, nor did they induce any adverse reactions. The key is to determine if these antibodies affect the drug's ability to work," said Corey Ford, M.D., director of the Multiple Sclerosis Specialty Clinic of New Mexico, University of New Mexico, Albuquerque. "This data confirmed that with Copaxone, the antibodies do not interfere with clinical efficacy. There is no neutralizing antibody issue with Copaxone."

All beta interferons have the potential to develop neutralizing antibodies, according to the beta interferon product labels. In the Journal of Neurology, Neurosurgery and Psychiatry 2002:73:465-469, Giovannoni, et al., stated that, "Because of the cross reactivity of the antibodies, a switch from one preparation to the other will not benefit patients while they are NAB positive."

"If a person with relapsing-remitting MS develops neutralizing antibodies to one interferon-beta drug, then that person is likely to have neutralizing antibodies to all of the interferon-beta medications," said Dr. Ford. "That is what is referred to as cross reactivity. If a relapsing-remitting MS patient is not responding to therapy and develops neutralizing antibodies to an interferon, their neurologist should consider a non-interferon medication, such as Copaxone."

Copaxone (glatiramer acetate injection) 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 35 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.

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.


SOURCE: Teva Neuroscience

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