Biogen Idec Initiates Phase III Clinical Program of Oral Compound BG-12 for Multiple Sclerosis



    Biogen Idec (NASDAQ: BIIB) announced today that it has initiated
    the Phase III clinical program of BG-12, an oral fumarate in
    development for relapsing-remitting multiple sclerosis (MS).

    The DEFINE (determination of the efficacy and safety of oral
    fumarate in relapsing-remitting MS) and CONFIRM (comparator and an
    oral fumarate in relapsing-remitting MS) studies will include more
    than 2,000 total patients in North America, Europe and rest of world.
    These studies have been initiated internationally, and Biogen Idec
    plans to initiate these studies in the U.S. later this year. DEFINE
    and CONFIRM are two-year, randomized, multi-center, double-blind,
    placebo-controlled, dose-comparison studies to determine the safety
    and efficacy of BG-12 in subjects with relapsing-remitting MS. CONFIRM
    will also include a glatiramer acetate (Copaxone(R)) reference
    comparator arm.

    Endpoints of both studies include evaluating the effect of BG-12
    on measurements of clinical relapse, the progression of disability,
    and various MRI measures.

    "Earlier studies of BG-12 support its potential as an oral therapy
    for multiple sclerosis. The extensive Phase III clinical program of
    BG-12 will provide greater understanding of its promise in MS," said
    DEFINE lead investigator Ralf Gold, MD, Professor and Chair of the
    Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum.
    "MS is a disease that continues to have an unmet need for safe and
    effective oral therapeutic options."

    "The development of BG-12 furthers Biogen Idec's commitment to
    advancing the treatment of MS. We have a diverse portfolio of
    therapeutic candidates and are dedicated to the pursuit of innovative
    research that will yield multiple options for people living with this
    devastating disease,"said Alfred Sandrock, MD, PhD, Senior Vice
    President, Neurology Research and Development, Biogen Idec.

    BG-12 Phase II Study Results

    Data from a Phase II study designed to evaluate the efficacy and
    safety of BG-12 were presented at two European neurological medical
    meetings in 2006. The Phase II multi-center, double-blind,
    placebo-controlled, dose-ranging study enrolled 257 patients at sites
    in 10 countries in Europe. Patients were randomized to receive placebo
    or BG-12 at 120 mg, 360 mg, or 720 mg per day orally for six months.
    The patient group treated with 720 mg of BG-12 per day had a 69%
    reduction (p<0.001) in the mean number of new gadolinium-enhancing
    lesions versus placebo as measured monthly from weeks 12 to 24 of the
    study. The 720 mg dose group also had a 48% reduction (p<0.001) in new
    or newly enlarging T2-hyperintense lesions at six months compared to
    baseline. Although the study was not powered to achieve statistical
    significance for this endpoint, there was a 32% reduction (p=0.272) in
    relapse rate compared to placebo at the 720 mg dose. The results of
    the 120 mg and 360 mg BG-12-treated groups were not statistically
    significant versus placebo on any endpoints.

    The most common adverse events were flushing, gastrointestinal
    disorders, headache, and nasopharyngitis. The incidence of liver
    enzyme elevation greater than or equal to three times the upper limit
    of normal at any time during the placebo controlled phase of the study
    was between 2% and 8% in the three active treatment groups, compared
    with 5% in the placebo group. Improvement in liver enzyme levels was
    seen after discontinuation of BG-12. The overall rate of infection was
    the same in the total BG-12-and placebo-treated groups, and no
    opportunistic infections occurred.

    About BG-12

    Data suggest that BG-12, an oral fumarate derivative, is an
    immunomodulator with a novel mechanism of action with a combination of
    cytoprotective and anti-inflammatory properties. Based on available
    clinical and scientific information with BG-12 and fumarates, there is
    strong technical rationale for development of BG-12 in a number of
    T-cell mediated autoimmune and/or inflammatory diseases.

    About Biogen Idec

    Biogen Idec creates new standards of care in oncology, neurology
    and immunology. As a global leader in the development, manufacturing,
    and commercialization of novel therapies, Biogen Idec transforms
    scientific discoveries into advances in human healthcare. For product
    labeling, press releases and additional information about the company,
    please visit http://www.biogenidec.com.

    Safe Harbor/Forward-Looking Statements

    This press release contains forward-looking statements regarding
    the development of BG-12 for multiple sclerosis. These statements are
    based on our current beliefs and expectations. They are subject to the
    risks inherent in drug development, including the risks that the
    effects of the product in larger clinical trials may not be as
    expected or that there may be safety issues or other problems or
    delays that arise during clinical trials, unexpected technical or
    manufacturing hurdles, or intellectual property disputes. There is no
    certainty that the risk/benefit profile of the product will be
    acceptable to the Company or to regulatory authorities for a
    particular indication. Drug development involves a high degree of
    risk. Only a small number of research and development programs result
    in the commercialization of a product. Success in early stage clinical
    trials does not ensure that later stage or larger scale clinical
    trials will be successful. For more detailed information on the risks
    and uncertainties associated with these forward looking statements and
    Biogen Idec's other activities, see the periodic and other reports
    that Biogen Idec has filed with the SEC. Biogen Idec does not
    undertake any obligation to publicly update any forward-looking
    statements.