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     457  0 Kommentare 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

    Jerusalem, Israel and Lund, Sweden, August 8, 2012 - 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."


    ABOUT LAQUINIMOD
    Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel
    mechanism of action being developed for the treatment of MS. In animal models
    laquinimod crosses the blood brain barrier to potentially have a direct effect
    on resident CNS inflammation and neurodegeneration. The global Phase III
    clinical development program evaluating oral laquinimod in MS includes two
    pivotal studies, ALLEGRO and BRAVO.

    In addition to the MS clinical studies, laquinimod is currently in Phase II of
    development for Crohn´s disease and Lupus.

    ABOUT SPECIAL PROTOCOL ASSESMENT (SPA)
    A SPA is a written agreement between the FDA (Food and Drug Administration) and
    a drug sponsor intended to confirm that the clinical trial protocol is adequate
    to meet current scientific and regulatory requirements for a potential new drug
    application.

    ABOUT MULTIPLE SCLEROSIS
    MS is the leading cause of neurological disability in young adults. It is
    estimated that more than 400,000 people in the United States are affected by the
    disease and that two million people may be affected worldwide. Multiple
    sclerosis is a degenerative disease of the central nervous system in which

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    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 AdministrationJerusalem, Israel and Lund, Sweden, August 8, 2012 - Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech …