Teva, Active Biotech Complete Enrollment in RRMS Trial

Teva Pharmaceutical Industries and Active Biotech have completed 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.

“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients’ unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety,” said Moshe Manor, Teva’s group vice president, Global Branded Products. “We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients.”

The companies recruited more than 1,200 patients at 156 sites in the U.S., Europe, Israel and South Africa for this trial. The first global Phase III trial of laquinimod completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites. The trial is currently ongoing. In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).