Teva Pharmaceutical (TEVA) and Active Biotech Complete Enrollment in Second Oral Laquinimod Phase III MS Clinical Trial

June 25, 2009 8:10 AM EDT

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech announced completion of patient enrollment for the second pivotal Phase III clinical trial, BRAVO, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS). BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex(R).

The BRAVO study completed patient enrollment in June, recruiting more than 1,200 patients at 156 sites in the United States, Europe, Israel and South Africa.

ALLEGRO, the first global Phase III trial of laquinimod, completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites in North America, Europe and Asia. The trial is currently ongoing.

In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Teva Pharmaceutical Industries Limited (Teva) is a global pharmaceutical company that develops, produces and markets generic drugs covering all treatment categories. [SM]


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