- Phase 2 monotherapy trial to be initiated by end of 2007 -
PRAGUE, Czech Republic, Oct. 11 /PRNewswire-FirstCall/ -- Biogen Idec
Inc. (Nasdaq: BIIB) and PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) announced
today that Phase 2 data demonstrated a significant reduction in new or
enlarged gadolinium-enhancing lesions when daclizumab is added to
interferon beta therapy in patients with active relapsing multiple
sclerosis (MS). These data will be presented tomorrow at the 23rd Congress
of the European Committee for Treatment and Research of Multiple Sclerosis
(ECTRIMS) in Prague, Czech Republic.
The ongoing Phase 2, randomized, double blind, placebo-controlled
clinical study, known as the CHOICE trial, studies MS patients who continue
to have active MS disease while receiving interferon beta therapy. The
study patients who received daclizumab 2 mg/kg subcutaneously every two
weeks showed a statistically significant 72% reduction in the number of new
or enlarged gadolinium-enhancing lesions (Gd+) at week 24, compared to
patients on interferon beta therapy alone. Patients from the CHOICE study
were followed for an additional 48 weeks after the daclizumab treatment
period to further assess safety and efficacy.
"Patients who received daclizumab every two weeks experienced far fewer
new or enlarged gadolinium-enhancing lesions than the control group, which
indicates that the antibody may be a promising option for patients with
MS," said Dr. Xavier Montalban, Director of the Unit of Clinical
Neuroimmunology at the Hospital Val D'Hebron in Barcelona, Spain. "In
addition, we were encouraged to see a trend in the reduction of the number
of relapses, or exacerbations, that these MS patients experienced. Further
study is warranted."
Daclizumab is a humanized monoclonal antibody that targets the IL-2
receptor on activated T cells. Biogen Idec and PDL plan to initiate the
SELECT study, a Phase 2 trial of daclizumab alone in the same relapsing
patient population, by the end of 2007.
"We are very pleased to see positive results from the CHOICE study, the
first randomized trial of daclizumab in patients with relapsing MS," said
Mark A. McCamish, M.D., Ph.D., chief medical officer, PDL BioPharma. "We
recognize how monoclonal antibodies have changed modern medicine and see
great potential in their ability to treat serious diseases, including
cancer and select immunological diseases such as MS. We're very excited to
move development of daclizumab forward with our partner Biogen Idec, the
acknowledged leader in the MS field."
"Daclizumab represents an exciting opportunity within our growing MS
portfolio," said Alfred Sandrock, M.D., Ph.D., senior vice president,
neurology research and development, Biogen Idec. "MS is a complex disease
that requires an arsenal of treatment options for patients. We look forward
to advancing the daclizumab development program and initiating the SELECT
trial by the end of the year."
Study Results
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 primary efficacy analysis showed that at 24 weeks, the 75 patients
in the 2 mg/kg group experienced 72% fewer new or 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 products.
About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects
approximately 400,000 people in North America and more than one million
people worldwide. It is a disease that affects more women than men, with
onset typically occurring between 20 and 50 years of age. MS is caused by
damage to myelin, the protective sheath surrounding nerve fibers in the
central nervous system, which interferes with messages from the brain to
the body. Symptoms of MS may include vision problems, loss of balance,
numbness, difficulty walking and paralysis.
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-related diseases. Hoffmann-La Roche, Inc.
currently markets daclizumab under the name Zenapax(R) under a license from
PDL. Zenapax is indicated for intravenous use for the prophylaxis of acute
organ rejection in patients receiving renal transplants. To conduct the
CHOICE study, PDL prepared a high concentration formulation of
Roche-produced daclizumab for subcutaneous administration. PDL has also
developed a high yield manufacturing process and formulation for
subcutaneously delivered daclizumab, which is in clinical development for
MS by PDL and Biogen Idec. PDL has retained the rights for development of
daclizumab for asthma and transplant maintenance.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with
high unmet medical needs. Founded in 1978, Biogen Idec is a global leader
in the discovery, development, manufacturing, and commercialization of
innovative therapies. Patients in more than 90 countries benefit from
Biogen Idec's significant products that address diseases such as lymphoma,
multiple sclerosis, and rheumatoid arthritis. 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. For more information, please visit
http://www.pdl.com.
Forward-looking Statement
This press release contains "forward-looking statements" regarding PDL
and Biogen Idec's development of daclizumab that are based on current
expectations and assumptions that are subject to risks and uncertainties.
Only a small number of research and development programs result in
commercialization of a product. Factors which could cause actual results to
differ materially from PDL and Biogen Idec's current expectations include
the risk that 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. In
addition, the companies may not be able to meet applicable regulatory
standards or regulatory authorities may fail to approve daclizumab; and the
companies may encounter other unexpected hurdles. 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. PDL and Biogen Idec assume no obligation to update
and specifically disclaim 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. All forward-looking
statements in this press release are qualified in their entirety by this
cautionary statement.
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 Hoffmann-La Roche,
Inc.
SOURCE Biogen Idec Inc.
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Related links:
http://www.pdl.com
CONTACT:
Media, Amy Reilly, Associate Director, Public
Affairs of Biogen Idec Inc., +1-617-679-3860; or Investment
Community, Eric S. Hoffman, Ph.D., Associate Director, Investor
Relations of Biogen Idec Inc., +1-617-679-2812; or Kathleen
Rinehart, Director, Corporate Communications of PDL BioPharma,
+1-650-454-2543; or Jean Suzuki, Manager, Investor Relations of
PDL BioPharma +1-650-454-2648
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