Primary Endpoint Met in Phase 2 Trial of Daclizumab in Patients With Relapsing Multiple Sclerosis

- Anti-IL-2 receptor antibody significantly reduced the number of new or

enlarged lesions compared to placebo; data to be submitted for presentation

at upcoming medical meeting -

- Phase 2 monotherapy trial to be initiated -

Mar 12, 2007, 01:00 ET from PDL BioPharma, Inc.

    CAMBRIDGE, Mass. and FREMONT, Calif., March 12 /PRNewswire-FirstCall/
 -- Biogen Idec, Inc. (Nasdaq:   BIIB) and PDL BioPharma, Inc. (PDL) (Nasdaq:  
 PDLI) announced today that the ongoing CHOICE trial, a Phase 2, randomized,
 double-blind, placebo-controlled trial of daclizumab, met its primary
 endpoint in relapsing multiple sclerosis (MS) patients being treated with
 interferon beta. Patients receiving daclizumab 2 mg/kg subcutaneously every
 2 weeks showed a significant reduction in the number of new or enlarged
 gadolinium-contrast-enhancing lesions (Gd-CELs) at week 24.
     Daclizumab is a humanized monoclonal antibody that targets the IL-2
 receptor on activated T cells. Study results will be submitted for
 presentation at an upcoming medical meeting later this year. Based on a
 joint review of the 24-week data, the companies plan to initiate a Phase 2
 monotherapy trial of daclizumab, and to advance the overall clinical
 development program in relapsing MS.
     "We are very pleased to see positive results from the first randomized
 trial of daclizumab in patients with relapsing MS, and we look forward to
 advancing the clinical development program with our partner and
 acknowledged leader in the MS field, Biogen Idec," said Mark A. McCamish,
 M.D., Ph.D., chief medical officer, PDL BioPharma. "While the week 24 data
 set will be presented later this year, we are planning to move forward with
 additional development activities, most notably the initiation of the
 SELECT trial, which will study daclizumab as a single agent in patients
 with relapsing MS."
     "We congratulate PDL on conducting a successful trial of daclizumab in
 MS," said Al Sandrock, M.D., Ph.D., senior vice president, neurology
 research and development, Biogen Idec. "Daclizumab represents an exciting
 opportunity within our growing MS portfolio. We look forward to initiating
 the SELECT trial and continuing to work closely with our partner, PDL, in
 advancing this important clinical program."
     The adverse event profile observed to date in this study is generally
 consistent with the safety profile described in the United States (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.
     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
     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 products.
     About Daclizumab
     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
 for MS by PDL and Biogen Idec, and separately by PDL in asthma and
 transplant maintenance. Hoffman-La Roche, Inc. currently markets daclizumab
 under the name Zenapax(R) under a license from PDL. Zenapax antibody is
 indicated for the prophylaxis of acute organ rejection in patients
 receiving renal transplants.
     About Biogen Idec
     Biogen Idec creates new standards of care in oncology, neurology and
 immunology. As a global leader in the development, manufacturing, and
 commercialization of novel therapies, Biogen Idec transforms scientific
 discoveries into advances in human healthcare. For product labeling, press
 releases and additional information about the company, please visit .
     About PDL BioPharma
     PDL BioPharma, Inc. is a biopharmaceutical company focused on
 discovering, developing and commercializing innovative therapies for severe
 or life-threatening illnesses. Commercially focused in the acute-care
 hospital setting, PDL markets and sells its portfolio of leading products
 in the United States and Canada. A pioneer of antibody humanization
 technology, PDL promotes this technology through licensing agreements and
 clinical development of its own diverse pipeline of investigational
 compounds. PDL's research platform centers on the discovery and development
 of antibodies to treat cancer and autoimmune diseases. For more
 information, please visit .
     Forward-looking Statement
     The information in this press release should be considered accurate
 only as of the date of the release. Neither PDL nor Biogen Idec has any
 intention of updating and specifically disclaims any duty to update the
 information in this press release for any reason, except as required by
 law, even as new information becomes available or other events occur in the
 future. This press release may contain "forward-looking statements" that
 are based on current expectations and assumptions that are subject to risks
 and uncertainties. The actual results may differ materially from those in
 the forward-looking statements because of various factors, risks and
 uncertainties. In particular, the preliminary results observed in the Phase
 2 trial known as CHOICE are based on week 24 data and may not be predictive
 of the results that would be observed upon review of the full set of data
 PDL and Biogen Idec plan to obtain through week 72. In addition, these
 preliminary results may not be predictive of results to be obtained in the
 additional evaluations and studies that would be necessary to demonstrate
 daclizumab to be safe and effective in the treatment of patients with
 relapsing MS, nor can there be assurance that PDL or Biogen Idec will
 initiate subsequent clinical trials of daclizumab, including the Phase 2
 monotherapy trial known as SELECT, which PDL and Biogen Idec are currently
 planning. For further information regarding factors, risks and
 uncertainties that may cause such differences, please refer to the filings
 PDL and Biogen Idec have made with the Securities and Exchange Commission,
 including the "Risk Factors" sections of PDL's and Biogen Idec's Quarterly
 and Annual Reports, copies of which may be obtained at the "Investors"
 section on PDL's website at, with respect to PDL's filings, and
 at , with respect to Biogen Idec's filings. All forward-
 looking statements in this press release are qualified in their entirety by
 this cautionary statement.
     NOTE: Biogen Idec is considered a trademark of Biogen Idec, Inc. PDL
 BioPharma and the PDL BioPharma logo are considered trademarks of PDL
 BioPharma, Inc. Zenapax is a registered trademark of Hoffman-La Roche, Inc.

SOURCE PDL BioPharma, Inc.