New Data on TYSABRI(R) Presented at ECTRIMS Congress Demonstrate Significant Improvement in Cognitive Function in Patients with Multiple Sclerosis



    Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN)
    announced today that data from the Phase III AFFIRM monotherapy study
    demonstrated that treatment with TYSABRI(R) (natalizumab)
    significantly reduced the proportion of multiple sclerosis (MS)
    patients with worsening cognitive function as measured by the 3-second
    Paced Auditory Serial Addition Test (PASAT 3). These data, presented
    at the 22nd Congress of the European Committee for Treatment and
    Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, contribute
    to existing data which demonstrate the overall therapeutic benefits of
    TYSABRI, including its significant impact on relapse reduction,
    disability progression and MRI measures. TYSABRI has demonstrated a
    68% relative reduction in the annualized relapse rate compared to
    placebo and a 42% reduction in the relative risk of disability
    progression, as published in the New England Journal of Medicine.

    Cognitive deficits are under-recognized and often misdiagnosed as
    depression, stress or other personality disorders. Studies have shown
    that approximately 43% to 65% of MS patients show measurable cognitive
    impairment in formal testing.(1) Cognitive dysfunction can occur early
    in MS and in patients with relatively mild physical disability. These
    deficits have a substantial effect on the daily functioning of
    patients. Areas impacted by cognitive dysfunction include memory,
    ability to process information and learning. (1),(2)

    The AFFIRM study was a two-year, randomized, multi-center,
    placebo-controlled, double-blind study of 942 patients conducted in 99
    sites worldwide, evaluating the effect of TYSABRI on the progression
    of disability and the rate of clinical relapses. Evaluating the effect
    of TYSABRI on cognitive function was a pre-specified endpoint of the
    AFFIRM study. Cognitive function was assessed using the 3-second Paced
    Auditory Serial Addition Test (PASAT 3), a test of auditory
    information processing. The study showed that treatment with TYSABRI
    reduced the risk of sustained cognitive worsening by 43% (p=0.013)
    when compared to placebo.

    These cognitive function data complement the previously presented
    results of the AFFIRM study, which demonstrated a significant effect
    of TYSABRI on two-widely accepted health-related quality of life
    measures, the Short Form-36 Health Survey and the Visual Analogue
    Scale.

    "Neuropsychological dysfunction significantly diminishes quality
    of life in many patients with multiple sclerosis, impacting everything
    from employment to social interaction. It is responsible for much
    hardship experienced by MS patients. The important positive effects of
    TYSABRI on cognitive functioning and quality of life add to the
    important benefits already reported on progression of disability and
    relapses. This provides strong evidence that observed neurologic
    benefits translate into important improvements as perceived by the
    patients," said Richard Rudick, MD, Director of the Mellen Center for
    Multiple Sclerosis Treatment and Research at the Cleveland Clinic.

    About TYSABRI

    In the US, TYSABRI is approved as a monotherapy treatment for
    relapsing forms of MS. TYSABRI increases the risk of progressive
    multifocal leukoencephalopathy (PML), an opportunistic viral infection
    of the brain that usually leads to death or severe disability.
    Patients should be monitored at regular intervals for any new or
    worsening signs or symptoms suggestive of PML. Because of the
    increased risk of PML, TYSABRI is generally recommended for patients
    who have had an inadequate response to, or are unable to tolerate,
    alternate MS therapies. It is available in the US only through a
    restricted distribution program called the TOUCH Prescribing Program.
    According to product labeling, after two years, TYSABRI treatment led
    to a 67% relative reduction (p<0.001) in the annualized relapse rate
    compared to placebo and reduced the relative risk of disability
    progression by 42% (p<0.001). TYSABRI treatment also resulted in
    sustained and statistically significant reductions in brain lesion
    activity as measured by MRI. Changes in MRI findings often do not
    correlate with changes in the clinical status of patients (e.g.,
    disability progression). The prognostic significance of the MRI
    findings in these studies has not been evaluated.

    In the European Union, TYSABRI is indicated as a single
    disease-modifying therapy in highly active relapsing-remitting MS
    patients. Because of the increased risk of PML, it is for patients
    with high disease activity despite treatment with a beta-interferon or
    in patients with rapidly evolving severe relapsing-remitting MS.
    According to product labeling in the EU, after two years, TYSABRI
    treatment led to a 68% relative reduction (p<0.001) in the annualized
    relapse rate compared to placebo and reduced the relative risk of
    disability progression by 42-54% (p<0.001).

    Serious adverse events that occurred in TYSABRI-treated patients
    included hypersensitivity reactions (e.g., anaphylaxis), infections,
    depression and gallstones. 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. Herpes infections were slightly more common in patients
    treated with TYSABRI. Serious opportunistic and other atypical
    infections have been observed in TYSABRI-treated patients, some of
    whom were receiving concurrent immunosuppressants. 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.

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

    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 www.biogenidec.com.

    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.

    Safe Harbor/Forward Looking Statements

    This press release contains forward-looking statements regarding
    TYSABRI. These statements are based on the companies' current beliefs
    and expectations. The commercial potential of TYSABRI is 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 we may be unable to adequately address concerns
    or questions raised by FDA or other regulatory authorities, that
    concerns may arise from additional data, that the incidence and/or
    risk of PML or other opportunistic infections in patients treated with
    TYSABRI may be higher than observed in clinical trials, or that the
    companies may encounter other unexpected hurdles. 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 and
    current 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.

    (1) Rao SM, et al. Neurology. 1991;41:685-691

    (2) Amato MP, et al. Arch Neurol. 1995;52:168-172