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Natalizumab Rheumatoid Arthritis Trial Initiated

DUBLIN & CAMBRIDGE, Mass. & SAN DIEGO--(BUSINESS WIRE)--Feb. 3, 2004--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.

Source: Elan Corporation, plc and Biogen Idec

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