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Elan and Biogen Idec announce results from Phase III maintenance trial of Antegren

l, patients were re-randomized to receive 300 mg of natalizumab (n=168) or placebo (n=171), both administered monthly for 12 months. The primary endpoints of maintenance of response and remission were assessed through six months.

Throughout six months of treatment with natalizumab, 61 percent of patients (103/168) continued to respond to therapy (assessed monthly) compared with 29 percent (49/170) of patients on placebo (p<0.001). In addition to meeting the primary endpoint of clinical response, 44 percent of patients (57/130) maintained clinical remission versus 26 percent of patients (31/120) on placebo (p=0.003). Fifty-four percent of natalizumab-treated patients (36/67) taking corticosteroids in ENACT-1, re-randomized in ENACT-2, were able to withdraw from corticosteroids and maintain response and remission, compared to 25 percent (19/76) of patients on placebo (p=0.002). There were no notable differences in the rate of serious or non-serious adverse events between treatment groups. The most common drug-related adverse events encountered in either treatment group in this trial were headache, fatigue and nausea.

In addition to the presentation of ENACT-2 data, there are six abstracts being presented at DDW on the Phase III induction study, ENACT-1. Highlights of these data will be discussed during a joint conference call on May 19 at 11:00 a.m. Central Time. Details of the call, including playback information, is accessible through Elan's homepage, www.elan.com and Biogen Idec's homepage, www.biogenidec.com.

"We are encouraged by the ENACT-2 data, which continues to build the evidence for the potential of natalizumab as a treatment for Crohn's disease," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "The data suggest that natalizumab maintains response, even in most cases when patients are withdrawn from corticosteroid therapy. Importantly, natalizumab appears to be well tolerated in thi
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Contact: Amy Losak
amy.losak@ketchum.com
646-935-3917
Ketchum
18-May-2004


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