TEVA AND ACTIVE BIOTECH REPORT POSITIVE RESULTS FROM PHASE IIa STUDY OF LAQUINIMOD IN ACTIVE LUPUS NEPHRITIS

·         Laquinimod showed additive effect in improving renal function when combined with the standard of care treatment
·         Results provide rationale for further studies of laquinimod in active lupus nephritis to confirm the safety and efficacy profile observed in this study

 

Jerusalem, Israel and Lund, Sweden, June 12^th, 2013 - Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus)that can lead to chronic kidney failure¹. Treatment with laquinimod provided an additive effect in improving renal function when combined with current standard of care for active lupus nephritis (mycophenolate mofetil and corticosteroids), compared with standard of care alone. The data will be presented during the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, 12-15 June, 2013 as part of the late-breaking news session.

"The favorable trends towards laquinimod treatment in the renal end-points, coupled with the safety and tolerability profile, provide a rationale for further Phase III clinical studies," said Principal Investigator Dr. David Jayne, Vasculitis and Lupus Clinic, Addenbrooke's Hospital, Cambridge.

"The results from this clinical study further our understanding of how the immunomodulatory profile of laquinimod may benefit patients with lupus," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer of Teva. "The development program for laquinimod, which also includes clinical studies for other auto-immune disorders like multiple sclerosis and Crohn's disease, underscores Teva's continued commitment to bringing innovative and differentiated medicines to improve patients' lives."

The clinical trial, NCT01085097, was a multicenter, double-blind, placebo-controlled, exploratory study of 46 patients with active lupus nephritis that evaluated oral laquinimod (0.5 and 1mg/day) versus placebo in combination with standard of care treatment. The study showed that at 24 weeks, 62.5% of patients with active lupus nephritis who received 0.5mg/day of laquinimod achieved renal response, compared to 33.3% of patients who were administered placebo. Renal response is a composite end point that measures several parameters of renal improvement.