Antegren (natalizumab) clinical study results published in New England Journal o...( Dublin Ireland and Cambridge MA Janu...)

Dublin, Ireland and Cambridge, MA, January 2, 2003 Elan Corporation, plc (NYSE: ELN) ("Elan") and Biogen, Inc. (NASDAQ: BGEN) ("Biogen") announce the publication of two clinical study reports on ANTEGREN (natalizumab) in today's issue of the New England Journal of Medicine. Natalizumab, a humanized monoclonal antibody, showed promising results on disease remission and improved quality of life for patients with Crohn's disease in an investigational study, according to results published today. Crohn's disease, a chronic, progressive and immune-related inflammatory disease of the gastrointestinal tract, can cause a range of debilitating symptoms such as severe diarrhea, crampy abdominal pain and malnutrition. Current treatment options for the disease are limited.

Crohn's Disease Study Design and Results
The randomized, double-blind, placebo-controlled, parallel group, Phase II study of 248 patients with Crohn's disease presented in the New England Journal of Medicine was conducted in eight countries at 35 clinical trial sites. Patients were randomized to one of four treatment groups: single 3 mg/kg natalizumab infusion followed by placebo (n=68); two 3 mg/kg natalizumab infusions at four-week intervals (n=66); two 6 mg/kg natalizumab infusions at four-week intervals (n=51), or placebo (n=63) and all groups were observed for at least 12 weeks following the first infusion. Patients with moderate- to-severe active Crohn's disease (Crohn's Disease Activity Index ("CDAI") scores of 220 to 450) were included in the study. The primary measure of effectiveness was clinical remission: a score of less than 150 on the CDAI. Clinical response was defined as a decrease of at least 70 points in the CDAI from baseline. Additional efficacy measures included quality of life assessments, as determined by the Inflammatory Bowel Disease Questionnaire ("IBDQ").

Although the primary endpoint of remission at 6 weeks in the 6 mg/kg dose group compared to plac
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Contact: Amy Losak
amy.losak@ketchum.com
646-935-3917
Ketchum
1-Jan-2003

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