NUTLEY, N.J. and FREMONT, Calif., Sept. 16 /PRNewswire-FirstCall/ -- Roche
and Protein Design Labs (PDL) (Nasdaq: PDLI) today announced a worldwide
agreement to co-develop and commercialize Zenapax(R) (daclizumab) for asthma
and related respiratory diseases, based on recent positive phase II data in
patients with moderate to severe asthma.
Mark McDade, Chief Executive Officer, PDL, said, "The continued
development of daclizumab in asthma is among PDL's highest clinical
development priorities. With Roche as our ongoing partner in this indication,
we believe daclizumab will obtain the resources needed to develop the full
potential of this humanized antibody in asthma."
"This new agreement will strengthen our pipeline in asthma, where we are
currently in phase II development of a novel oral treatment," said William
Burns, Global Head of Roche's Pharmaceuticals Division. "We believe that
daclizumab will offer patients a significant improvement over today's current
therapy. Our long-standing relationship with PDL continues to grow as we
develop daclizumab further."
Under terms of the agreement, PDL will receive a $17.5 million upfront
payment as well as up to $187.5 million in development and commercialization
milestones for successful further development of daclizumab. Roche and PDL
will globally co-develop daclizumab in asthma, share development expenses and
co-promote the product in the US. Outside the US, PDL will receive royalties
on net sales of the product in asthma.
About the Roche - PDL partnership
In 1989, Roche acquired the worldwide rights to daclizumab, a product that
has since gained an important position within Roche's transplantation
portfolio. In October 2003, Roche resold to PDL all rights to daclizumab,
except in transplantation, until 2007 when PDL will have the option to
re-acquire the transplantation rights as well. In 2004, PDL approached Roche
with compelling phase II data for daclizumab in asthma, leading to today's
announcement for the continued co-development of daclizumab in respiratory
disorders by Roche and PDL.
About Asthma
Asthma is among the most common chronic medical conditions in the United
States and worldwide, affecting more than 20 million people in the United
States, according to the American Lung Association (ALA) and the American
Academy of Allergy, Asthma & Immunology (AAAAI). According to a recent report
on the global burden of asthma published by the NIH, WHO and the Global
Initiative for Asthma, asthma is one of the most common chronic diseases in
the world and it is estimated that around 300 million people in the world
currently have asthma. The rate of asthma continues to increase and it is
estimated that there may be an additional 100 million persons suffering from
asthma by 2025. Asthma accounts for 1 in every 250 deaths worldwide.
About Zenapax
Zenapax is an immunosuppressive humanized monoclonal antibody or
"anti-rejection" drug approved by the FDA in December 1997 to be used in
combination with other immunosuppressive drugs (cyclosporine and
corticosteroids) to prevent acute organ rejection in kidney transplant
patients. The recommended dose of Zenapax is 1.0 mg/kg. Based on clinical
trials, the standard course of Zenapax therapy is five doses.
The most frequently reported adverse events associated with Zenapax were
constipation, nausea, diarrhea and vomiting. Cellulitis and wound infections
occurred more frequently in patients treated with Zenapax versus placebo.
Severe hypersensitivity reactions following Zenapax administration have been
reported rarely.
Only physicians experienced in immunosuppressive therapy and management of
organ transplant patients should prescribe Zenapax. The physician responsible
for Zenapax administration should have complete information requisite for the
follow-up of the patient. Zenapax should be administered only by healthcare
personnel trained in the administration of the drug who have available
adequate laboratory and supportive medical resources.
About Protein Design Labs
In October 2003, PDL acquired all rights to Zenapax(R), excluding
transplantation indications but with the option to gain such indication rights
by 2007. PDL retains this right in accordance with the terms of the October
2003 agreement.
Protein Design Labs is a leader in the development of humanized antibodies
to prevent or treat various disease conditions. PDL currently has antibodies
under development for autoimmune and inflammatory conditions, asthma and
cancer. PDL holds fundamental patents for its antibody humanization
technology. Further information on PDL is available at http://www.pdl.com.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
prescription drug unit of the Roche Group, a leading research-based health
care enterprise that ranks among the world's leaders in pharmaceuticals and
diagnostics. Roche discovers, develops, manufactures and markets numerous
important prescription drugs that enhance people's health, well-being and
quality of life. Among the company's areas of therapeutic interest are:
dermatology; genitourinary disease; infectious diseases, including influenza;
inflammation, including arthritis and osteoporosis; metabolic diseases,
including obesity and diabetes; neurology; oncology; transplantation; vascular
diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United
States, visit the company's web site at: http://www.rocheusa.com .
Webcast scheduled for 8:30 a.m. Eastern time on September 16.
PDL will host a webcast beginning at 8:30 a.m. Eastern time on September
16, 2004, to discuss the joint development and commercialization agreement.
The live webcast will be available through the PDL website: http://www.pdl.com.
Please connect to this website at least 15 minutes prior to the live webcast
to allow time for any software download that may be needed to hear the
webcast. A replay will be available at http://www.pdl.com starting approximately one
hour after completion of the webcast.
An audio replay will also be available by telephone from approximately
10:30 a.m. Eastern time on September 16, 2004 through 10:30 a.m. Eastern time
on September 21, 2004. To access the replay, dial 800-633-8284 from inside the
United States and 402-977-9140 from outside the United States; enter
conference ID number 21207310.
Conditions
The foregoing contains forward-looking statements involving risks and
uncertainties and PDL's actual results may differ materially from those in the
forward-looking statements. Factors that may cause such differences are
discussed in PDL's Annual Report on Form 10-K for the year ended December 31,
2003, in its Quarterly Report on Form 10-Q for the three months ended June 30,
2004, and in other filings made with the Securities and Exchange Commission.
In particular, results obtained in the Phase II study may not be predictive of
results to be obtained in the additional evaluations that would be necessary
to demonstrate the antibody to be safe and effective in the treatment of
asthma, nor can there be assurance that PDL will initiate subsequent clinical
trials in asthma.
NOTE: Protein Design Labs and the PDL logo are registered U.S. trademarks
of Protein Design Labs, Inc. Zenapax is a registered trademark of Roche.
SOURCE Protein Design Labs, Inc.
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Related links:
http://www.pdl.com
CONTACT:
James R. Goff, Senior Director, Corporate
Communications, of Protein Design Labs, +1-510-574-1421, or
jgoff@pdl.com; or Pamela Van Houten, Director, Public Affairs, of
Roche, +1-973-562-2231, or pamela.vanhouten@roche.com
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