Teva Multiple Sclerosis drug gets fast-track status

Fast track status is for treatments of serious or life-threatening conditions.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA)'s oral treatment for multiple sclerosis, Laquinimod, was granted "fast track" designation by the US Food and Drug Administration (FDA). Fast Track designation can potentially facilitate development and expedite the review process. According to Teva, this may allow the drug to enter the market as soon as late 2011.

Teva has set out on two Phase III clinical trials of the drug. For its first study, Allegro, Teva completed enrollment in November, 2008, and is now enrolling patients for its second Phase III trial, Bravo.

The announcement was reported by Teva and Active Biotech (NASDAQ OMX NORDIC: ACTI). Active Biotech developed Laquinimod and licensed it to Teva in June 2004.

Drugs designated for Fast Track are intended for the treatment of a serious or life-threatening condition and have demonstrated the potential to address unmet medical needs.

National MS Society executive vice president, research and clinical programs, Dr. John Richert said, “We're encouraged by the reports we've seen from the Phase II clinical trial of Laquinimod, and if this agent continues to prove safe and effective, it would be a welcome new treatment option available to people with multiple sclerosis."

Laquinimod is a once-daily, orally administered drug that is being developed as a disease-modifying treatment for relapsing/remitting multiple sclerosis (RRMS). Results from a Phase IIb study published in June 2008 in The Lancet showed that an oral 0.6 mg dose of Laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60% (51% mean reduction) versus placebo in RRMS patients.

Shares in Teva rose 0.25% to $44.01 on Nasdaq on Friday, giving a market cap of $34.24 billion.

Published by Globes [online], Israel business news - - on February 15, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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