Teva and Active Biotech Announce First Patient Enrolled in Phase II Study Evaluating Laquinimod for Primary Progressive MS

Phase II ARPEGGIO study design to be presented at the 67^th American Academy of Neurology (AAN) Annual Meeting, April 18-25, 2015

Jerusalem, Israel & Lund, Sweden - April 23, 2015 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced the first patient has been enrolled in the study A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO), a Phase II study to evaluate laquinimod, an investigational, oral, immune modulator, for the treatment of primary progressive multiple sclerosis (PPMS). Currently there are no approved treatments for PPMS, representing a condition with a high unmet need.

PPMS affects approximately 15 percent of all MS patients and is characterized by the worsening of neurologic function without distinct relapses (also called attacks or exacerbations). Unlike patients with relapsing-remitting MS (RRMS), those with PPMS tend to have more lesions in the spinal cord than in the brain and these brain lesions usually contain fewer inflammatory cells. In addition, all studies evaluating RRMS treatments in patients with PPMS have failed to prove effective for this condition.

"Laquinimod may represent an opportunity to help meet the challenge of PPMS," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. "The mechanisms of action and data from previous studies in RRMS suggest the effect of laquinimod is focused on the neurodegenerative aspects of the disease, which are pervasive in PPMS. We are hopeful that the ARPEGGIO study will demonstrate the ability of laquinimod to slow disability progression in PPMS and fulfill an unmet need for patients with this lifelong and debilitating disease."

ARPEGGIO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study of once-daily, oral laquinimod (0.6mg or 1.5mg/day) in patients with PPMS. The study's primary endpoint is percent brain volume change (PBVC) through MRI analysis. The trial will enroll approximately 375 patients in the U.S., Canada, and Europe.

Additional details on the study design will be presented at the AAN Annual Meeting in Washington, D.C. on Thursday, April 23, 2015 during Poster Session 7. For further details on the Phase II ARPEGGIO study, please visit clinicaltrials.gov/show/NCT02284568.