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AMCP 2006 Educational Conference

Biogen Idec and Elan Corporation, plc announced that data to be presented at the Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show that in Phase III studies TYSABRI (natalizumab) therapy significantly reduced corticosteroid use and hospitalizations, and increased the proportion of MS patients with no disease activity. Findings will also be presented that demonstrate the positive impact of TYSABRI on a number of health-related quality of life of measures (QoL) and the cost-effectiveness of MS therapies.

Data presented from the AFFIRM monotherapy study (two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified endpoints, the annualized rate of relapses requiring corticosteroid use and the annualized rate of hospitalizations due to MS. Data showed there was a 69% relative reduction in the annualized rate of relapses requiring steroids for patients treated with TYSABRI compared to those treated with placebo (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also showed that TYSABRI therapy resulted in a 65% relative reduction in the annualized rate of MS-related hospitalizations over two years (0.034 in the TYSABRI group vs. 0.097 in the placebo group(p<0.001)).

A post-hoc analysis was also conducted to determine the proportion of patients free of disease activity over two years. To determine this, a retrospective analysis was conducted to evaluate both clinical and magnetic resonance imaging (MRI) measures. Patients with no disease activity were defined as patients who experienced no additional relapses or progression of physical disability and exhibited stable MRI measures without any new gadolinium-enhancing, T2-hyperintense, or T1-hypointense lesions. Data presented today suggest that TYSABRI significantly increased the proportion of disease-free patients by 79% over two years compared with placebo (28% vs. 6%, respectively; p<0.001).



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