FEBRUARY 3, 2004 - 02:30 ET
Elan and Biogen Idec Announce Initiation of ANTEGREN
Rheumatoid Arthritis Trial; Phase II Study to Begin
First Half Of 2004
DUBLIN, IRELAND, CAMBRIDGE, MASSACHUSETTES and SAN DIEGO,
CALIFORNIA--Elan Corporation, plc and Biogen Idec today announced
that an Investigational New Drug (IND) Application for
ANTEGREN(R) (natalizumab) for the treatment of rheumatoid
arthritis (RA) has been filed with the U.S. Food and Drug
Administration (FDA). The commencement of a Phase II clinical
trial is on track to begin in the first half of this year.
RA is a chronic progressive autoimmune disease that affects
approximately 5.8 million people worldwide. RA often begins with
pain and stiffness in the small joints of the hands and feet and
can progress to involve other joints, sometimes with severe
disability and disfigurement. Natalizumab is of interest in
moderate-to-severe RA because of its novel mechanism of action.
"With the IND application process complete, we can now proceed
with the clinical trials that will evaluate the ability of
natalizumab to treat people with rheumatoid arthritis," said Lars
Ekman, MD, executive vice president and president, Research and
Development, Elan. "Additionally, we remain committed to the
further development of natalizumab in Crohn's disease and are
very encouraged by the recent positive news with the Phase III
maintenance trial."
The RA study will be a Phase II, multicenter, double-blind,
placebo-controlled study of the efficacy, safety and tolerability
of intravenous natalizumab (300 mg) in patients with
moderate-to-severe rheumatoid arthritis receiving concomitant
treatment with methotrexate.
"Elan and Biogen Idec look forward to investigating the potential
of natalizumab in the treatment of rheumatoid arthritis, a
therapeutic area with unmet medical need. In addition, our Phase
III multiple sclerosis studies for natalizumab are ongoing with
more than 2,000 patients enrolled," said Burt Adelman, MD,
executive vice president, Development, Biogen Idec.
About ANTEGREN (natalizumab)
Elan and Biogen Idec are collaborating on the development,
manufacturing and marketing of natalizumab, currently in Phase
III trials for multiple sclerosis (MS) and Crohn's disease.
Natalizumab, a humanized monoclonal antibody, has a novel
mechanism of action: it 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 tissue
-- the gastrointestinal tract in Crohn's disease, the brain in
MS, and the joints in RA -- where they may cause or maintain
inflammation. To date, more than 4,000 patients have participated
in natalizumab clinical studies.
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 elan.com.
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
biogenidec.com. |
