November 14, 2003
Business Wire 2003
Dendreon Corporation (Nasdaq:DNDN) today announced an agreement by which Dendreon has licensed to Kirin Brewery Co., Ltd. patent rights relating to the use of certain HLA-DR antibodies for which Kirin will pay $20 million and return full rights for Asia to Dendreon's lead product candidate, Provenge(R), that were previously licensed to Kirin. As a result of this agreement, Dendreon can now complete its ongoing discussions for a worldwide marketing and sales collaboration for Provenge and Kirin can now develop its HLA-DR monoclonal antibodies free of potential infringement claims arising from Dendreon's current HLA-DR patent rights.
"During our Provenge collaboration discussions, it became evident that Asia and the Pacific Rim are valuable territories to potential collaborators who see abundant opportunity for commercializing Provenge on a global basis. We are pleased that we were able to engage Kirin in these discussions and that Kirin has agreed to return rights to Provenge in Asia to facilitate our ongoing discussions with potential collaborators for a worldwide marketing and sales agreement," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "Kirin has been a great collaborator and this agreement is a win for both parties."
Provenge, an immunotherapy for prostate cancer, is currently in a pivotal double blind, placebo-controlled Phase 3 trial, D9902B, in men with androgen independent prostate cancer. The trial seeks to confirm results of a completed Phase 3 trial that indicate the investigational product may delay progression of disease and the development of disease-related pain. Dendreon has received a Fast Track designation for Provenge from the FDA in addition to a positive assessment under the Special Protocol Assessment (SPA) provision indicating that D9902B may serve as the basis for a Biologics License Application for Provenge.
Dendreon's licensing agreement with Kirin pertains to patent rights that Dendreon owns relating to monoclonal antibodies that target the HLA-DR antigen. Dendreon retains rights to develop and commercialize its two existing HLA-DR monoclonal antibodies, DN1921 and DN1924, as well as other HLA-DR antibodies not currently being developed by Kirin. In preclinical studies to date, such antibodies have been shown to induce apoptosis, or programmed cell death, in cancer cells expressing HLA-DR. Some of the antibodies have also been shown to induce immunosuppression and could potentially treat autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. The worldwide market for anti-HLA-DR antibodies is in excess of $6 billion.
Dendreon's agreement with Kirin will be filed with the Securities and Exchange Commission on Friday, November 14, 2003 as an exhibit to its Form 10-Q for the third quarter of 2003.
Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody, small molecule and prodrug product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon. com.
Except for historical information contained herein, this news release
contains forward-looking statements that are subject to risks and uncertainties
that may cause actual results to differ materially from the results discussed
in the forward-looking statements, particularly those risks and uncertainties
surrounding the efficacy and safety of Provenge to treat men with prostate
cancer, the risks and uncertainties surrounding presentation of data to
the FDA and the approval of product applications by the FDA, and risks
and uncertainties inherent in the process of discovering, developing and
commercializing drugs that are safe and effective for use as human therapeutics.
Factors that may cause such a difference include the risks that Dendreon
may be unable to secure a collaborator for commercialization of Provenge
on a global basis or that such collaboration may not be successful, the
risks that data from the first clinical trial of Provenge will not be confirmed
in the second trial, the risks that safety or efficacy results of a clinical
trial of Provenge will not support an application for a biologics license,
the risks that the FDA or similar agencies in other countries will not
approve a biologics license, the dependence on the efforts of third parties,
risks that the safety and/or efficacy results of preclinical studies will
not support further development of product candidates, risks associated
with development of monoclonal antibody product candidates through preclinical
and clinical research and development, risks associated with completing
Dendreon's clinical trials, the risks that the safety and/or efficacy results
of a clinical trial will not support an application for a biologics license,
the risk that the FDA or similar agencies in other countries will not approve
a product for which a biologics license has been applied, the uncertainty
of Dendreon's future access to capital, risks relating to Dendreon's relatively
limited operating history, the risks that a patent will not be granted
or that the claims will be restricted or challenged by a third party, and
the dependence on intellectual property. Further information on the factors
and risks that could affect Dendreon's business, financial condition and
results of operations, are contained in Dendreon's SEC reports, which are
available at www.sec.gov.
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