BIOGEN IDEC, PDL ANNOUNCE DATA ON DACLIZUMAB IN MS

Biogen Idec and PDL BioPharma have announced that the ongoing CHOICE trial, a Phase II, randomized, double-blind, placebo-controlled trial of daclizumab, met its primary endpoint in a trial involving relapsing multiple sclerosis (MS) patients being treated with interferon beta. Patients receiving daclizumab 2 mg/kg subcutaneously every two weeks showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions at week 24.

The CHOICE trial is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks or placebo added to ongoing interferon beta treatment.

The adverse event profile observed in this study is generally consistent with the safety profile described in the U.S. prescribing information for daclizumab. Patients are being followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy.

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.

Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune and related diseases. Daclizumab is in development separately by PDL in asthma and transplant maintenance. Hoffman-La Roche currently markets daclizumab under the name Zenapax for the prophylaxis of acute organ rejection in patients receiving renal transplants.