Teva's Copaxone effective against multiple sclerosis progression

A study is halted after an interim analysis so that all its patients can be given Copaxone.

A study by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has shown that Copaxone is effective in not only treating multiple sclerosis, but in preventing or delaying its progression. The study was stopped early so that patients in the placebo group could be given Copaxone.

Teva today announced the positive results from a pre-planned interim analysis of the PreCISe trial in patients presenting with a first clinical event and MRI features suggestive of multiple sclerosis (MS). The results showed that treatment with Copaxone reduced the risk of developing clinically definite MS (CDMS) by 44% versus placebo, and prolonged the quartile time to disease conversion to 722 days versus 336 days in those patients receiving placebo.

At the time of the interim analysis, the proportion of patients who had developed clinically definite MS was reduced from 43% in the placebo group to only 25% in the Copaxone group. Based on these results, Teva plans to file a request for marketing authorization of Copaxone in Europe, the US, and Canada for the treatment of patients with a first clinical event suggestive of multiple sclerosis.

Professor Paul O'Connor, Neurology Division Chief at St. Michael's Hospital, Toronto, Canada and the chairman of the study’s independent data monitoring committee (DMC), said, “After analyzing the data from the PreCISe study at the interim analysis, the DMC recommended that the placebo arm of the trial be stopped, as Copaxone successfully met the efficacy endpoint of the study; all placebo patients will now be given the opportunity to receive active treatment with Copaxone for two years."

This study further demonstrated the beneficial effect of early treatment with Copaxone on disease activity and burden, also in its early stages, as measured by both short-term clinical and magnetic resonance imaging (MRI) disease outcomes. Copaxone is the only relapsing-remitting MS (RRMS) treatment with data from a long-term, prospective, ongoing study which demonstrated that in those patients adhering to therapy, 92% still walk unassisted after a mean of 10 years of therapy and 18 years of disease duration.

The multi-national, multi-center, prospective, double-blind, randomized, Phase III PreCISe study was conducted in approximately 100 centers located in the US, Europe, Argentina, Israel, Nordic countries, Australia and New Zealand and included a total of 481 patients presenting with a single clinical episode and MRI suggestive of MS.

In afternoon trading on Nasdaq, Petah Tikva-based Teva's shares were up over 1.2% to $45.20, near the top of its 52 week range between $30.81 and $45.99. Its current price reflects a market cap of over $34.5 billion.

Published by Globes [online], Israel business news - www.globes-online.com - on December 3, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

Published by Globes [online], Israel business news - www.globes-online.com - on December 3, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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