Launch of Copaxone® in France Expected to Mirror European Success
September 25, 2003 02:18 AM US Eastern Timezone
Teva Pharmaceutical Industries Ltd. and Aventis announced today that Copaxone® (glatiramer acetate), used for the treatment of relapsing-remitting multiple sclerosis (RRMS) is now widely available (in both hospitals and private pharmacies) throughout France.
"Until now, Copaxone® was limited to hospital use. Now it can be dispatched through pharmacies which will benefit and provide hope to all people living with RRMS," said Olivier Jacquesson, Vice Chairman of Aventis Pharma, France
"France has the second largest prevalence of multiple sclerosis (MS) in Europe, with approximately 50,000 people diagnosed with the disease, approximately half of them suffering from RRMS. We are confident that the launch in France will mirror the success in the rest of Europe, where Copaxone® is gaining significant market share" said Israel Makov, President and CEO of Teva.
Copaxone® is indicated for the reduction of relapses rates in ambulatory patients (i.e. who can walk unaided) with RRMS characterized by at least two attacks of neurological dysfunction over the preceding two-year period.
As a first-line therapy and the only non-interferon treatment in the MS market, Copaxone® offers people living with RRMS in France a new option. Copaxone® is a unique disease modifying therapy with a dual mode of action which selectively down-regulates inflammation, while inducing the secretion of neuroprotective factors (BDNF, Brain Derived Neurotrophic Factor). In controlled clinical trials, Copaxone® has been successful in reducing relapse rates. An ongoing trial has shown that the long-term efficacy of Copaxone® is sustained for a period of eight years. Furthermore, the effect of Copaxone® has also been demonstrated on magnetic resonance imaging (MRI) burden of disease and the reduction of lesions evolving into permanent "black holes".
In accordance with 2002 market data, Copaxone® was the fastest growing MS therapy worldwide. More than 60,000 patients globally have been administering Copaxone® treatment. In the United States, Copaxone® has a market share of 28 percent of total prescriptions (IMS Aug 2003), and is growing faster than the rate of the MS market.
In France, Copaxone® is marketed by Teva Pharma SA and Laboratoire Aventis.
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 Inc.
Teva Pharmaceutical Industries Ltd., (NASDAQ: TEVA) headquartered in Israel, is among the top 30 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. For more information, please visit: www.tevapharm.com
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of euro 17.6 billion, invested euro 3.1 billion in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.
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.
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