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| |  Early Treatment Of Multiple Sclerosis With Copaxone (Glatiramer Acetate) Delays Accumulation Of Additional Brain Lesions KANSAS CITY, MO -- October 22, 2002 -- People living with relapsing-remitting multiple sclerosis who delay Copaxone® (glatiramer acetate for injection) treatment for as little as nine months can accumulate additional lesions in their brain, reported a study published in the October 22, 2002 issue of Neurology. The delay in starting therapy resulted in six new enhancing lesions per patient during the first nine study months that could have been prevented, according to the study. The study used magnetic resonance imaging (MRI) to evaluate the brain lesions for patients who were on Copaxone for the entire 18-month period compared to those who switched from placebo to active drug after nine months. There were 29 sites in Europe and Canada. Canadian trial sites involved in the study were located in Montreal, London and Calgary. "This study is significant because it showed that patients who started Copaxone earlier had 35 per cent fewer enhancing lesions over the study period of 18 months," said Dr Douglas Arnold, Director, Clinical Research Unit, Montreal Neurological Institute and Hospital (MNI/H). "Relapse rates for these same patients were 23 per cent lower than for patients who started on Copaxone nine months later and it appeared that delaying treatment with Copaxone resulted in a poorer clinical outcome." The study showed that the benefits gained in the first nine months were sustained through the entire 18 months, indicating a benefit from continuous drug therapy. The two-phase trial began as a nine-month placebo-controlled, double-blind study that showed that Copaxone significantly reduced MRI-measured brain lesions and reduced the relapse rate. The second phase, which is reported in this issue of Neurology, switched placebo patients to Copaxone, evaluating if those on Copaxone could sustain the benefit shown in the first nine months and whether there was a difference in those who began therapy later. The majority of patients (224 of 239) chose to enter the study continuation, where patients were evaluated clinically and through MRIs on a quarterly basis. "Over the extension, there was a 54-per cent reduction in the mean number of enhanced lesions for those converted from placebo to Copaxone and an additional 24.6 per cent reduction for those always on Copaxone," said Giancarlo Comi, M.D., of the Scientific Institute and University Ospedale San Raffaele, Milan, Italy. "Over the entire study, the accumulated T2 disease burden was less for those always on Copaxone." Copaxone 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 Copaxone 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. Copaxone is now approved in 41 countries worldwide, including Canada, the U.S., 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. (NASDAQ: TEVA), headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. More than 80 per cent of Teva's sales are in North America and Europe. The company develops, manufactures, and Copaxone (glatiramer acetate for injection) is a registered trademark of Teva Pharmaceutical Industries Ltd. 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 Pharmaceutical Industries Ltd.
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