- 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 -
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
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 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
http://www.biogenidec.com .
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 http://www.pdl.com .
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 http://www.pdl.com, with respect to PDL's filings, and
at http://www.biogenidec.com , 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.
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Related links:
http://www.biogenidec.com/
http://www.pdl.com/
CONTACT:
media, Amy Brockelman, Associate Director,
Public Affairs, +1-617-914-6524, or investors, Eric S. Hoffman,
Ph.D., Associate Director, Investor Relations, +1-617-679-2812,
both of Biogen Idec; or Ami Knoefler, Corporate and Investor
Relations, +1-510-284-8851, or ami.knoefler@pdl.com, or Jean
Suzuki, Corporate Relations, +1-510-574-1550, or
jean.suzuki@pdl.com, both of PDL BioPharma
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