Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn's Disease



    Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB)
    announced today that the Gastrointestinal Drugs Advisory Committee and
    the Drug Safety and Risk Management Advisory Committee of the U.S.
    Food and Drug Administration (FDA) voted 12 in favor to 3 opposed,
    with 2 abstaining, to recommend approval of TYSABRI(R) (natalizumab)
    as a treatment for moderate-to-severe Crohn's disease in patients who
    have failed or cannot tolerate available therapies.

    The recommendation is advisory to the FDA, and the agency is not
    bound by this recommendation. Elan and Biogen Idec will continue to
    work closely with the FDA in the weeks ahead with the goal of making
    TYSABRI available for the treatment of appropriate patients with
    Crohn's disease. Discussions with the FDA will include adapting the
    existing TYSABRI risk management plan and addressing any other issues
    raised during the Committees' deliberations on this new indication.

    About TYSABRI(R) (natalizumab)

    TYSABRI is a treatment approved for relapsing forms of multiple
    sclerosis (MS) in the US and relapsing-remitting MS in the European
    Union. According to data that have been published in the New England
    Journal of Medicine, after two years, TYSABRI treatment led to a 68%
    relative reduction (p less than 0.001) in the annualized relapse rate
    compared to placebo and reduced the relative risk of disability
    progression by 42-54% (p less than 0.001).

    TYSABRI increases the risk of progressive multifocal
    leukoencephalopathy (PML), an opportunistic viral infection of the
    brain that usually leads to death or severe disability. Other serious
    adverse events that have occurred in TYSABRI-treated patients included
    hypersensitivity reactions (e.g., anaphylaxis), infections, depression
    and gallstones. Serious opportunistic and other atypical infections
    have been observed in TYSABRI-treated patients, some of whom were
    receiving concurrent immunosuppressants. Herpes infections were
    slightly more common in patients treated with TYSABRI. In MS trials,
    the incidence and rate of other serious and common adverse events,
    including the overall incidence and rate of infections, were balanced
    between treatment groups. Common adverse events reported in
    TYSABRI-treated patients include headache, fatigue, infusion
    reactions, urinary tract infections, joint and limb pain, lower
    respiratory infections, rash, gastroenteritis, abdominal discomfort,
    vaginitis, and diarrhea.

    TYSABRI is approved in the United States, European Union,
    Switzerland, Canada, Australia and Israel. TYSABRI was discovered by
    Elan and is co-developed with Biogen Idec.

    For more information about TYSABRI please visit www.tysabri.com,
    www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

    About Elan

    Elan Corporation, plc is a neuroscience-based biotechnology
    company committed to making a difference in the lives of patients and
    their families by dedicating itself to bringing innovations in science
    to fill significant unmet medical needs that continue to exist around
    the world. Elan shares trade on the New York, London and Dublin Stock
    Exchanges. For additional information about the company, please visit
    www.elan.com.

    About Biogen Idec

    Biogen Idec creates new standards of care in therapeutic areas
    with high unmet medical needs. Founded in 1978, Biogen Idec is a
    global leader in the discovery, development, manufacturing, and
    commercialization of innovative therapies. Patients in more than 90
    countries benefit from Biogen Idec's significant products that address
    diseases such as lymphoma, multiple sclerosis, and rheumatoid
    arthritis. 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
    TYSABRI. The commercial potential and regulatory path forward of
    TYSABRI are subject to a number of risks and uncertainties. Factors
    which could cause actual results to differ materially from the
    companies' current expectations include the risk that concerns may
    arise from additional data or analysis or that the companies may
    encounter other unexpected delays or hurdles. There is also no
    assurance that the companies will be able to obtain approval for
    TYSABRI as a treatment for Crohn's disease. Drug development and
    commercialization involves a high degree of risk. For more detailed
    information on the risks and uncertainties associated with the
    companies' drug development and other activities, see the periodic
    reports that Biogen Idec and Elan have filed with the Securities and
    Exchange Commission. The companies assume no obligation to update any
    forward-looking statements, whether as a result of new information,
    future events or otherwise.