Teva to Initiate Third Phase III Trial of Oral Laquinimod for the Treatment of Relapsing Remitting Multiple Sclerosis

The clinical trial protocol has been granted a Special Protocol Assessment agreement by the Food and Drug Administration Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) provided today an update on the clinical development program of once-daily oral laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS). The companies are to initiate a third Phase III study of laquinimod, following the written agreement reached with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA). The third Phase III laquinimod trial CONCERTO will evaluate two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). "The results achieved in the previous Phase III trials of laquinimod support the clinical utility of this compound as a unique treatment option for multiple sclerosis," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer, Teva Pharmaceutical Industries Ltd. "We are encouraged by the FDA's agreement on the trial design and planned analysis, and look forward to further developing laquinimod as a potential treatment option for RRMS patients."