SEATTLE, Nov. 3 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that it has succeeded in reproducing the antigen used in the preparation of Provenge(R), the Company's investigational immunotherapy for the treatment of prostate cancer, at commercial manufacturing scale. The Company achieved this important milestone with its contract manufacturer, Diosynth Biotechnology, a unit of Akzo Nobel. Diosynth, a leader in process development and cGMP production of recombinant proteins/peptides for therapeutic and vaccine applications, has also made an investment in the Company by purchasing $3.5 million of Dendreon common stock in connection with the parties' antigen development agreement. This agreement has been expanded to complete the scope of work required for the chemistry, manufacturing and controls (CMC) section of a Biologics License Application for Provenge.
"This is a key step for Dendreon to ensure we have adequate capacity for the commercialization of Provenge," said Andrew Scherer, Dendreon's vice president of manufacturing. "We are pleased to be working with a world-class contract manufacturer like Diosynth. Their investment aligns our two companies toward one common goal."
"We are proud to be associated with Dendreon, a leading company in cancer immunotherapy," said Jo Lennartz, Ph.D., president of Diosynth Biotechnology. "We believe that Provenge has the potential to significantly improve the prospects of the millions of men who suffer from prostate cancer across the globe."
Provenge is designed to stimulate a patient's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in approximately 95 percent of prostate cancers, prostatic acid phosphatase (PAP).
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule 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 http://www.dendreon.com/.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of Provenge to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and 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 risks related to our limited operating history, risks that studies to verify the manufacturing process for the antigen used in Provenge will not be successful or completed in a timely manner, the risks that the manufacture of the antigen at commercial scale to validate the manufacturing process will not be successful or completed in a timely manner, the risks that the FDA will not conclude that the antigen manufactured at commercial scale is sufficiently similar to that manufactured for our clinical trials, the risk that market demand for Provenge, if Provenge is commercialized, will exceed our capacity to manufacture the antigen, the risks that we will be unable to negotiate an agreement for commercial supply of the antigen with Diosynth or another contract manufacturer, the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of Provenge, dependence on the efforts of third parties, including collaborators, and our 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 public disclosure filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov/.