Dendreon Corporation 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, 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.