Biogen Idec

Biogen Idec
Elan Corporation

Elan Corporation

February 17, 2005 02:43 ET

Biogen and Elan: TYSABRI'R' Two-Year Monotherapy Trial Demonstrates Significant Impact on Disability Progression and Relapse Rate in Multiple Sclerosis


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: BIOGEN IDEC

NASDAQ SYMBOL: BIIB

AND ELAN CORPORATION

NYSE SYMBOL: ELN

FEBRUARY 17, 2005 - 02:43 ET

Biogen and Elan: TYSABRI'R' Two-Year Monotherapy Trial
Demonstrates Significant Impact on Disability
Progression and Relapse Rate in Multiple Sclerosis

CAMBRIDGE, MASSACHUSETTS and DUBLIN, IRELAND--(CCNMatthews - Feb. 17,
2005) -

Data Show 42% Reduction in the Risk of Disability Progression and
Sustained 67% Reduction in Relapse Rate

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN)
announced today that the Phase III TYSABRI® (natalizumab) AFFIRM
monotherapy trial achieved the two-year primary endpoint of slowing the
progression of disability in patients with relapsing forms of multiple
sclerosis (MS). TYSABRI treatment led to a 42 percent reduction in the
risk of disability progression relative to placebo. These data also
demonstrated a 67 percent reduction in the rate of clinical relapses
over two years, which was sustained and consistent with the previously
reported one-year results.

Other data from AFFIRM at two years, including MRI measures and
immunogenicity were similar to previously reported results.

The adverse event profile at two years was also consistent with
previously reported results. Common events included headache, fatigue,
urinary tract infection, depression, lower respiratory tract infection,
limb and joint pain, and pharyngitis. The incidence of infections in
TYSABRI-treated and placebo-treated patients was similar. Serious
infections occurred in 3.2 percent and 2.6 percent of patients,
respectively. These included bacterial infections such as pneumonia and
urinary tract infection, which responded appropriately to antibiotics.
TYSABRI has also been associated with hypersensitivity reactions,
including serious systemic reactions that occurred at an incidence of
less than 1 percent of patients.

"TYSABRI, with its significant effect on slowing the progression of
disability, offers new hope for patients with MS," said Burt Adelman,
MD, executive vice president, Development, Biogen Idec. "With these
data, we gain a more complete understanding of the broad therapeutic
benefit of TYSABRI in MS."

"Results from the two-year monotherapy clinical trial mark a major
milestone in the treatment of MS. These two-year data strengthen our
belief that TYSABRI will become the leading therapy for MS patients,"
said Lars Ekman, MD, executive vice president and president, Research
and Development, Elan.

AFFIRM is 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 as
measured by the Expanded Disability Status Scale (EDSS) and the rate of
clinical relapses. Patients were randomized to receive either a 300 mg
IV infusion dose of TYSABRI (n-627) or placebo (n-315) every four weeks.

Based on one-year data from AFFIRM and the SENTINEL add-on trial with
AVONEX® (Interferon beta-1a), the U.S. Food and Drug Administration
(FDA) granted Accelerated Approval for TYSABRI on November 23, 2004, as
a treatment for relapsing forms of MS.

The companies anticipate that two-year data from the AFFIRM trial will
be presented at the American Academy of Neurology (AAN) meeting in April
2005. The companies expect two-year results from the SENTINEL trial will
be available mid-year. Two-year data from both studies will also be
submitted to regulatory authorities.

About TYSABRI

TYSABRI, the first humanized monoclonal antibody approved for the
treatment of MS, inhibits adhesion molecules on the surface of immune
cells. Research suggests TYSABRI works by preventing immune cells from
migrating from the bloodstream into the brain where they can cause
inflammation and potentially damage nerve fibers and their insulation.

Biogen Idec and Elan are collaborating equally on the development of
TYSABRI in MS, Crohn's disease (CD), and rheumatoid arthritis (RA).
Regulatory authorities in Canada and Australia have designated TYSABRI
for Priority Review as a treatment for MS, and the European Medicines
Agency (EMEA) is actively reviewing the application.

In September 2004, the companies submitted a Marketing Authorisation
Application (MAA) to the EMEA for CD based on Phase III studies. Another
Phase III induction trial for CD is ongoing. A Phase II trial is also
underway to evaluate TYSABRI in RA. To date, more than 3,200 patients
have received TYSABRI in clinical trials.

Information about TYSABRI, including U.S. prescribing information, and
its comprehensive support services in the U.S., is available through a
single toll-free number (1-800-456-2255), and via www.TYSABRI.com.

About Multiple Sclerosis

MS is a chronic disease of the central nervous system that affects
approximately 400,000 people in North America and more than one million
people worldwide. It is a disease that affects more women than men, with
onset typically occurring between 20 and 40 years of age. Symptoms of MS
may include vision problems, loss of balance, numbness, difficulty
walking and paralysis.

About Biogen Idec

Biogen Idec creates new standards of care in oncology 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.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company. We
are committed to making a difference in the lives of patients and their
families by dedicating ourselves 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
http://www.elan.com.

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding the
potential for TYSABRI. These statements are based on the companies'
current beliefs and expectations, and are subject to risks and
uncertainties that could cause actual results to differ materially.
There is no assurance, for example, that all experiences with TYSABRI
will be the same or that the potential for TYSABRI will not be affected
by unexpected new data or technical issues. The potential for TYSABRI
may also be influenced by reimbursement and pricing decisions, the
impact of competitive products, the pace of market acceptance, or by
intellectual property disputes, and any material issues, delays or
failures related to its manufacturing and supply. For more detailed
information on the risks and uncertainties associated with TYSABRI and
the companies' drug development and other activities, see the periodic
and other reports of Biogen Idec Inc. and Elan Corporation, plc 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.

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    Media Contacts:
    Biogen Idec
    Amy Brockelman, 617-914-6524
    or
    Elan
    Anita Kawatra, 212-407-5740 or 800-252-3526
    or
    Investor Contacts:
    Biogen Idec
    Elizabeth Woo, 617-679-2812
    or
    Elan
    Emer Reynolds, 353 1 709 4000 or 800-252-3526