Change in the clinical development program for laquinimodFebruary 19, 2014 14:00 (CET)
Lund, Sweden, February 19, 2014 - Active Biotech (NASDAQ OMX NORDIC: ACTI) today announces that its partner Teva Pharmaceuticals (NYSE: TEVA), has decided not to proceed to the randomization stage of the planned Libretto trial for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS), as the current design is no longer aligned with the regulatory strategy. This decision has no impact on other ongoing studies, such as CONCERTO, which are proceeding as planned, or on Teva Pharmaceuticals' plans to initiate clinical studies in Primary Progressive Multiple Sclerosis (PPMS).
About laquinimod (Nerventra®)
Laquinimod (Nerventra®) is an oral, investigational, CNS-active immunomodulator with a novel mechanism of action primarily being developed for the treatment of relapsing-remitting MS (RRMS). The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial, CONCERTO, is evaluating 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 time to confirmed disability progression as measured by the EDSS. In addition to the MS clinical studies, laquinimod has concluded Phase II of development for Crohn's disease and lupus nephritis.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod (Nerventra®), an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, tasquinimod for prostate cancer and ANYARA primarily for the treatment of renal cell cancer. In addition, laquinimod Phase II clinical trials in Crohn's and Lupus has been concluded. The company also has one additional project in clinical development, the orally administered compound paquinimod (57-57) for systemic sclerosis. Please visit www.activebiotech.com for more information.
For further information:
| Tomas Leanderson, President & CEO |
Tel: +46 46 19 20 95
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
| Hans Kolam, CFO |
Tel: +46 46 19 20 44
Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication 2:00 pm CET on February 19, 2014.