Agreement Covers Daclizumab for Multiple Sclerosis; M200 and HuZAF(TM) in
Multiple Indications
Companies to Conduct Conference Call and Webcast at 4:30 p.m. Eastern Time
CAMBRIDGE, Mass. and FREMONT, Calif., Aug. 2 /PRNewswire-FirstCall/ --
Biogen Idec (Nasdaq: BIIB) and Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI)
today announced a broad collaboration for the joint development, manufacture
and commercialization of three Phase II antibody products. The agreement
provides for shared development and commercialization of daclizumab in
multiple sclerosis and indications other than transplant and respiratory
diseases, and for shared development and commercialization of M200
(volociximab) and HuZAF(TM) (fontolizumab) in all indications.
Under terms of the agreement, PDL will receive an upfront payment of $40
million, and Biogen Idec will purchase $100 million of common stock from PDL.
If multiple products were developed successfully in multiple indications and
all milestones were achieved, PDL could receive certain development and
commercialization milestone payments totaling up to $660 million. Of these,
$560 million are related to development and $100 million are related to
commercialization of collaboration products.
Biogen Idec and PDL will share equally the costs of all development
activities and all operating profits from each collaboration product within
the United States and Europe. The companies will jointly oversee development,
manufacturing and commercialization plans for collaboration products and
intend to divide implementation responsibilities to leverage each company's
capabilities and expertise. Each party will have co-promotion rights in the
United States and Europe. Outside the United States and Europe, Biogen Idec
will fund all incremental development and commercialization costs and pay a
royalty to PDL on sales of collaboration products.
"We are very pleased to forge a comprehensive global collaboration on
these three products with PDL," said Jim Mullen, President and CEO of Biogen
Idec. "This partnership will expand our oncology presence in solid tumors,
while strengthening our position as a leader in multiple sclerosis research
and development."
Mark McDade, Chief Executive Officer, PDL, said, "As a world leader in the
treatment of multiple sclerosis and the originator of the successful cancer
treatment, Rituxan(R) (rituximab), we believe Biogen Idec is an outstanding
partner with whom to globally develop and commercialize these three novel
antibody products. We are obviously excited to forge this collaboration that
advances our pipeline, accelerates our path to sustainable positive cash flow
and paves the way to commercialization of the next wave of PDL products. From
our perspective, this alliance enables both companies to share costs and risks
of developing products that address large market opportunities, while
leveraging our respective development, manufacturing and commercial
strengths."
The closing of the transaction, including the stock purchase, will be
subject to antitrust review and approval, and other standard closing
conditions. The purchase of the stock will be at fair market value. The
stock purchase agreement also provides for a registration statement to be
filed for the common stock and the re-sale of the stock is subject to certain
limitations.
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. A Phase II clinical trial of daclizumab in
multiple sclerosis is ongoing. Rights to daclizumab in transplantation, asthma
and related respiratory diseases are in partnership with Roche.
About M200 (volociximab)
Volociximab is a novel anti-angiogenic chimeric antibody directed against
alpha5 beta1 integrin. Binding of the antibody to alpha5 beta1 integrin
inhibits the formation of new blood vessels, a process necessary for tumor
growth. Results from a Phase I study in advanced solid tumors suggest that
volociximab was well tolerated and did not identify dose-limiting toxicities.
Three Phase II clinical trials of volociximab in renal cell carcinoma,
melanoma and pancreatic cancers were initiated in the first half of 2005. A
fourth Phase II study in non-small cell lung cancer is anticipated to begin
shortly. Preclinical data with volociximab suggest the antibody may also have
potential as a treatment for age-related macular degeneration.
About HuZAF(TM) (fontolizumab)
Fontolizumab is a humanized antibody that binds to interferon-gamma, an
important immunoregulatory cytokine with multiple activities, including up-
regulation of MHC Class II molecule expression. Blocking interferon-gamma may
be useful in treating a variety of autoimmune diseases.
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
PDL is a biopharmaceutical company focused on the research, development
and commercialization of novel therapies for inflammation and autoimmune
diseases, acute cardiac conditions and cancer. PDL markets several
biopharmaceutical products in the United States through its hospital sales
force and wholly-owned subsidiary, ESP Pharma, Inc. As a leader in the
development of humanized antibodies, PDL has licensed its patents to numerous
pharmaceutical and biotechnology companies, some of which are now paying
royalties on net sales of licensed products. Further information on PDL is
available at http://www.pdl.com.
Conference Call and Webcast Information
Biogen Idec and PDL will conduct a conference call to discuss the
collaboration agreement today, August 2, at 4:30 p.m. Eastern time. The
conference call can be accessed by dialing (415) 537-1977. A live webcast of
the conference call also will be available through the Biogen Idec website,
http://www.biogenidec.com, as well the PDL website, http://www.pdl.com. Please connect to
one of these websites 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, including the presentation materials, will be available at
http://www.biogenidec.com and at http://www.pdl.com starting approximately one hour after
completion of the webcast. A replay will also be available by telephone from
approximately 6:30 p.m. Eastern time on August 2, 2005 through 6:30 p.m.
Eastern time on August 10, 2005. To access the replay, dial 800-633-8284 from
inside the United States and 402-977-9140 from outside the United States and
enter conference ID number 21256614.
Regarding PDL
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. In particular, there can be no assurance that the
parties will successfully develop or achieve the milestone events on any of
the products or that the conditions to the stock purchase agreement will be
satisfied, that the parties will perform their obligations under the agreement
as anticipated. While the parties are bound to proceed with certain
obligations, the agreement contains provisions under which parties can reduce
or eliminate their obligations to develop, manufacture and commercialize
products, and no assurance can be given that either party will proceed with
the development and commercialization of any product. Other factors that may
affect the development and commercialization of products are discussed in
PDL's Annual Report on Form 10-K for the year ended December 31, 2004, and in
its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 and in
other filings made with the Securities and Exchange Commission. All
statements included in this press release are based upon information available
to PDL as of the date hereof, and PDL assumes no obligation to update any such
forward-looking statements.
NOTE: Protein Design Labs and the PDL logo are registered U.S. trademarks
of Protein Design Labs, Inc.
Regarding Biogen Idec
This press release contains forward-looking statements regarding the
development, manufacture and commercialization of products under the Biogen
Idec/PDL collaboration. Forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially from those
expressed or implied by the forward-looking statements. Drug development
generally involves a high degree of risk. For example, there is no assurance
that the effectiveness of the products in larger clinical trials will be as
expected or that safety issues will not arise. There is also no assurance
that the development, manufacture or commercialization of these products will
not be affected by unexpected technical or manufacturing hurdles or
intellectual property disputes. For more detailed information on the risks
and uncertainties associated with Biogen Idec's drug development and other
activities, see the periodic and other reports that Biogen Idec has filed with
the Securities and Exchange Commission. Biogen Idec assumes no obligation to
update any forward-looking statements, whether as a result of new information,
future events or otherwise.
SOURCE Protein Design Labs, Inc.
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Related links:
http://www.pdl.com
CONTACT:
media, Jose Juves, Associate Director, Public
Affairs, +1-617-914-6524, or investors, Oscar Velastegui, Senior
Manager, Investor Relations, +1-617-679-2812, both of Biogen
Idec; or Ami Knoefler, Senior Director, Corporate
Communications/Investor Relations, +1-510-284-8851, or
aknoefler@pdl.com, or Jim Goff, Senior Director, Investor
Relations, +1-510-574-1421, or jgoff@pdl.com, both of Protein
Design Labs, Inc.
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