25 May 2004
Source: Elan Corporation, plc and Biogen Idec
Medical News Today
Biogen Idec and Elan Corporation, plc announced today that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of Antegren® (natalizumab) for the treatment of multiple sclerosis (MS).
The submission includes one-year data from two ongoing Phase III trials. The companies are committed to completing these two-year trials. In order to protect the integrity of the trials, the companies are not disclosing the one-year data at this time.
"Based on the one-year analysis from our Phase III studies, which include more than 2,100 patients, we believe that natalizumab has the potential to become an important new therapy for MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "Natalizumab's novel mechanism of action represents an innovative approach to treating MS."
"This submission represents a significant milestone for Elan and Biogen Idec and demonstrates our continued commitment to providing a new treatment option for the more than one million patients experiencing the debilitating effects of MS," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We look forward to working with the FDA throughout the review process to make natalizumab available to patients who may be in need."
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 the MS Clinical Trials for ANTEGREN
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® (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 study protocols provided for 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 rate. The pre-specified primary endpoint of the one-year analysis was relapse rate.
About Antegren (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. The drug is designed to inhibit the migration of immune cells into chronically inflamed tissue 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). The companies intend to submit an application for drug approval in Europe for MS by the end of the second quarter of 2004.
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.
Elan Corporation, plc is a neuroscience-based biotechnology company that is focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, and severe pain. 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
approval of Antegren (natalizumab) and the potential of natalizumab as
a treatment for MS. These statements are based on the companies' current
beliefs and expectation. Drug development involves a high degree of risk.
Factors which could cause actual results to differ materially from the
companies' current expectations include: the risk that unexpected concerns
may arise from additional data or analysis, that regulatory authorities
may require additional information, further studies, or may fail to approve
the drug, or that the companies may encounter other unexpected hurdles.
For more detailed information on the risks and uncertainties associated
with the companies' drug development and other activities, see the periodic
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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