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Biologics License Application Accepted for Natalizumab in Multiple Sclerosis

CAMBRIDGE, Mass. & SAN DIEGO & DUBLIN, Ireland--(BUSINESS WIRE)--July 26, 2004--Biogen Idec and Elan Corporation, plc announced today that the U.S. Food and Drug Administration (FDA) has formally accepted their Biologics License Application (BLA) for Antegren (natalizumab). In June 2004, the FDA designated natalizumab for Priority Review and Accelerated Approval for the treatment of multiple sclerosis (MS). Acceptance of a filing indicates that the FDA has determined that the application is complete and permits a substantive review.

The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for natalizumab in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On May 25, 2004, the companies announced they had previously submitted the BLA for the approval of natalizumab for MS.

The FDA's review of natalizumab will be based on one-year data from two ongoing Phase III trials, AFFIRM (natalizumab safety and efficacy in relapsing-remitting MS) and SENTINEL (safety and efficacy of natalizumab in combination with Avonex(R) (Interferon beta-1a)), which evaluate the ability of natalizumab to slow the progression of disability and reduce the rate of clinical relapses in patients with relapsing-remitting MS. The companies are committed to completing these two-year trials.

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

About Antegren (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. It is designed to inhibit the migration of immune cells into tissues where they may cause or maintain inflammation. To date, approximately 2,800 patients have received natalizumab in clinical trials, and the safety profile continues to support further development. In placebo-controlled trials to date, in both Crohn's disease (CD) and MS, the most commonly reported adverse events in either group were headache, fatigue and nasopharyngitis.

Biogen Idec and Elan are collaborating equally on the development of natalizumab in MS, CD, and rheumatoid arthritis (RA).

Source: Biogen Idec and Elan Corporation, plc

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