Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Be... (enlarged Gd+ on averagecompared to the 7...)

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Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Beta Therapy

Date:10/11/2007

enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1 mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.

Based on data up to week 24, analysis of the relapse rate, which was a secondary endpoint, indicates that both daclizumab regimens revealed a trend in reducing the annualized relapse rate compared to placebo (an approximately 35% reduction), but these observations did not reach statistical significance.

Preliminary safety data showed similar rates of infection across all treatment groups with an overall greater incidence of serious infections in the daclizumab treated groups. (4.6% versus 1.3% placebo). Urinary tract infections were slightly higher with the 2 mg/kg dose (17% vs 13% placebo). The incidence of cutaneous events was higher in the combined daclizumab groups (34% daclizumab vs. 27% placebo) but was mild to moderate and most resolved with little or no treatment.

PDL and Biogen Idec entered into a collaboration agreement in 2005 to co- develop and commercialize daclizumab in MS and indications other than transplant and respiratory diseases. Under the collaboration, the companies are also co-developing volociximab (also known as M200), an antibody in Phase 2 development for the treatment of various solid tumors. PDL and Biogen Idec share equally the costs of all development activities and all operating profits for both products within the U.S. and Europe. The companies jointly oversee development, manufacturing and commercialization plans for collaboration products and divide implementation responsibilities to leverage each company's capabilities and expertise. Each party will have co-promotion rights in the U.S. and Europe. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration pr
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Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Be...(enlarged Gd+ on averagecompared to the 7...)