Third Phase III Research to Begin by Active Biotech and Teva Pharmaceuticals

Teva Pharmaceutical Industries Ltd. and Active Biotech provided presently an update upon the clinical development plan of once-daily oral laquinimod regarding the remedy for relapsing-remitting multiple sclerosis (RRMS). The companies are to actually start a 3rd Phase III study of laquinimod, implementing the written agreement met with the U.S. Food and Drug Administration (FDA) upon the Special Protocol Assessment (SPA).

The third Phase III laquinimod trial CONCERTO is likely to evaluate two prescriptions of the investigational product in approximately 1,800 affected individuals for approximately 24 months. The leading outcome action will be tested disability development as examined by the Expanded Disability Status Scale (EDSS).

"The outcomes achieved within the previous Phase III trials of laquinimod aid the clinical utility in this compound as an exclusive treatment method intended for multiple sclerosis," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer, Teva Pharmaceutical Industries Ltd. "We are motivated by the FDA's contract upon the trial design and deliberate analysis, and look forward to actually further producing laquinimod as a potential treatment method for RRMS affected individuals."