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More MS news articles for May 2004

Potential synergistic effect of Copaxone® and minocycline to be studied in relapsing-remitting multiple sclerosis

New study in Canada evaluating the potential add-on effect

May 31, 2004
Source: Teva Pharmaceutical Industries Ltd.
CNW Telbec

A new study assessing the add-on effect of minocycline in relapsing-remitting multiple sclerosis (RRMS) patients with active disease who are treated with CopaxoneŽ (glatiramer acetate injection) has just been initiated at four major investigation sites in Canada: Calgary, Vancouver, Edmonton and Montreal.

"The primary efficacy objective of this study is to evaluate the add-on treatment effect of oral minocycline in subjects treated with a daily injection of glatiramer acetate as measured by various MRI parameters," said Dr. Luanne Metz, professor at the Department of Clinical Neuroscience of the University of Calgary, and principal investigator. "Other study objectives include the assessment of tolerability and safety of this combination."

Approximately 50 patients will be evaluated in the four designated study centers for a total duration of nine months. This study is a double blind, randomized study designed to compare the combination of glatiramer acetate plus oral minocycline to glatiramer acetate plus placebo.

"This particular study is exciting because it provides us with the perfect opportunity to determine if there are synergies between minocycline and glatiramer acetate that would provide even greater control in managing MS," added Dr. Metz.

Minocycline, an antibiotic, eliminates bacteria that cause pneumonia, acne, and infections of skin, genital and urinary systems, and the central nervous system.

CopaxoneŽ is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. In controlled clinical trials, the most commonly observed adverse events associated with the use of CopaxoneŽ which occurred at a higher frequency than in placebo treated patients were: injection site reactions, vasodilation, chest pain, asthenia, infection, pain, nausea, arthralgia, anxiety and hypertonia.

CopaxoneŽ is now approved in 42 countries worldwide, including Canada, the U.S., Australia, Israel, and all the European countries. In Europe, CopaxoneŽ is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, CopaxoneŽ is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies in the world. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. 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.

CopaxoneŽ 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, including its recent acquisition of Sicor Inc., 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 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. 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.

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