CAMBRIDGE, Mass. & SAN DIEGO & DUBLIN, Ireland--(BUSINESS
WIRE)--Feb. 18, 2004--Biogen Idec and Elan Corporation, plc today
announced that they expect to submit to the U.S. Food and Drug
Administration (FDA) an application for approval of ANTEGREN(R) (natalizumab)
as a treatment for multiple sclerosis (MS). The companies expect to
submit the filing mid-year 2004.
The decision to file a Biologics License Application (BLA) was
made after discussions with the FDA of one-year data from the two
ongoing two-year Phase III trials in MS. The companies are committed
to completing the two-year trials. To protect the integrity of the
trials, the companies are not disclosing the one-year data at this
time.
Biogen Idec and Elan are collaborating equally on the development
of natalizumab for MS, Crohn's disease, and rheumatoid arthritis.
About the ANTEGREN MS Clinical Trials
The AFFIRM (natalizumab safety and efficacy in
relapsing-remitting MS) trial is a two-year, randomized,
multi-center, placebo-controlled, double-blind study of
approximately 900 patients, evaluating the ability of natalizumab to
slow the progression of disability in MS and reduce the rate of
clinical relapses. The SENTINEL (safety and efficacy of natalizumab
in combination with AVONEX(R) (Interferon beta-1a)) trial is a
two-year, randomized, multi-center, placebo-controlled, double-blind
study of approximately 1,200 patients with relapsing-remitting MS,
evaluating the effect of the combination of natalizumab and AVONEX
compared to treatment with AVONEX alone in slowing the progression
of disability and reducing the rate of clinical relapses. Both
studies have protocols that included a one-year analysis of the
data. The primary endpoints for both Phase III two-year trials in MS
are based on the Expanded Disability Status Scale (EDSS) and relapse
rates. The pre-specified primary endpoint of the one-year analysis
was relapse rates.
About ANTEGREN (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first
alpha-4 antagonist in the new SAM (selective adhesion molecule)
inhibitor class. The drug was designed to selectively inhibit immune
cells from leaving the bloodstream and to prevent these cells from
migrating into chronically inflamed tissue as occurs in a variety of
inflammatory diseases. To date, approximately 2,800 patients have
received natalizumab in clinical studies. In previous clinical
trials, the following adverse events occurred more commonly with
natalizumab when compared to placebo: headache, nausea, abdominal
pain, infection, urinary tract infection, pharyngitis and rash.
Serious adverse events have included infrequent
hypersensitivity-like reactions.
About Biogen Idec
Biogen Idec (NASDAQ: BIIB) 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 (NYSE: ELN) is focused on the discovery,
development, manufacturing, selling and marketing of novel
therapeutic products in neurology, severe pain and autoimmune
diseases. Elan shares trade on the New York, London and Dublin Stock
Exchanges. For additional information about the company, please
visit
http://www.elan.com.
