New Pharmacoeconomic Data on TYSABRI(R) Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis



    Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN)
    announced that data to be presented today at the Academy of Managed
    Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show
    that in Phase III studies TYSABRI(R) (natalizumab) therapy
    significantly reduced corticosteroid use and hospitalizations, and
    increased the proportion of MS patients with no disease activity.
    Findings will also be presented that demonstrate the positive impact
    of TYSABRI on a number of health-related quality of life of measures
    (QoL) and the cost-effectiveness of MS therapies.

    Data Demonstrate TYSABRI Reduced Corticosteroid Use,
    Hospitalizations and Increases the Proportion of Disease-Free Patients

    Data presented today from the AFFIRM monotherapy study (two-year,
    randomized, multi-center, placebo-controlled, double-blind study of
    942 patients conducted in 99 sites worldwide), showed the impact of
    TYSABRI on two pre-specified endpoints, the annualized rate of
    relapses requiring corticosteroid use and the annualized rate of
    hospitalizations due to MS. Data showed there was a 69% relative
    reduction in the annualized rate of relapses requiring steroids for
    patients treated with TYSABRI compared to those treated with placebo
    (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)).
    The study also showed that TYSABRI therapy resulted in a 65% relative
    reduction in the annualized rate of MS-related hospitalizations over
    two years (0.034 in the TYSABRI group vs. 0.097 in the placebo
    group(p<0.001)).

    A post-hoc analysis was also conducted to determine the proportion
    of patients free of disease activity over two years. To determine
    this, a retrospective analysis was conducted to evaluate both clinical
    and magnetic resonance imaging (MRI) measures. Patients with no
    disease activity were defined as patients who experienced no
    additional relapses or progression of physical disability and
    exhibited stable MRI measures without any new gadolinium-enhancing,
    T2-hyperintense, or T1-hypointense lesions. Data presented today
    suggest that TYSABRI significantly increased the proportion of
    disease-free patients by 79% over two years compared with placebo (28%
    vs. 6%, respectively; p<0.001).

    Cost Effectiveness of MS Therapies

    A model was constructed by Xcenda, formerly Applied Health
    Outcomes, to compare the cost per relapse avoided among the five
    approved disease-modifying MS therapies to treat relapsing forms of
    MS. Overall cost of therapy was calculated using the US wholesale
    acquisition drug cost, and costs associated with drug administration,
    patient monitoring and treatment of relapses. The costs associated
    with adverse events were not assessed as part of this model.
    Effectiveness was defined as the number of relapses avoided with
    treatment, which was calculated as the number of relapses for a
    non-treated population multiplied by published relapse rate reductions
    for the therapies.(1) Based on the model developed, the cost per
    relapse per year avoided was lowest for TYSABRI. The cost per relapse
    avoided for TYSABRI was between $12,730 and $23,274 lower than that of
    the other approved disease-modifying therapies.

    Data Show TYSABRI Had Improvement in Quality of Life Assessments

    Quality of Life (QoL) was assessed using three different measures,
    the Multiple Sclerosis Quality of Life Inventory (MSQLI), the Short
    Form-36 Health Survey (SF-36), which is a component of the MSQLI, and
    a Visual Analogue Scale (VAS). The MSQLI is an MS-specific battery of
    10 scales that measure disease impact on QoL, including fatigue, pain,
    sexual function, bowel and bladder function, visual impairment, mental
    health and need for social support. The SF-36 is comprised of 36
    questions designed to assess patients' physical and mental well-being.
    General well-being was also measured using the VAS.

    In data presented today from the AFFIRM study, patients in the
    TYSABRI-treated group realized a significant improvement in physical
    measures of the SF-36 compared with a decline in the placebo-treated
    group (p=0.003). A significant improvement was also seen in the mental
    component of the SF-36 in patients treated with TYSABRI compared with
    a decline in the placebo-group (p=0.011). Significant benefits were
    also seen using the VAS (p=0.007).

    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) The relapse reduction rates used were: TYSABRI was 67%, AVONEX
    (Interferon beta-1a IM) 32%, Betaseron(R) (Interferon beta-1b) 34%,
    Copaxone(R) (glatiramer acetate) 29%, and Rebif(R) (Interferon beta-1a
    SC) 32%.