SEATTLE, Feb. 2 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that it has named 30-year industry veteran Mary Y. Coon vice president of quality.
Ms. Coon will oversee quality assurance of all manufacturing operations, specifically leading the implementation and oversight of quality systems and Good Manufacturing Practices compliance at Dendreon's new manufacturing facility in East Hanover, N.J.
She will report to David Urdal, Ph.D., senior vice president and chief scientific officer, who is responsible for manufacturing and quality operations as part of a strategic corporate realignment initiative to focus efforts on the submission of a Biologics Licensing Application (BLA) for PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the potential treatment of advanced prostate cancer.
"Mary is a seasoned industry veteran whose leadership skills and extensive quality control, regulatory and manufacturing experience will greatly contribute to the preparation of the PROVENGE BLA," said Dr. Urdal. "We look forward to gaining the benefit of Mary's expertise as we complete the activities necessary for validation of our manufacturing facility and prepare for the pre-inspection by the FDA and commercial production of PROVENGE."
PROVENGE has Fast Track designation and the Company plans to begin submitting the BLA to the U.S. Food and Drug Administration on a rolling basis by the middle of this year. The Company will apply for Priority Review upon completion of its BLA submission later this year.
Ms. Coon most recently served as vice president of quality and regulatory affairs at Bioport Corporation, an anthrax vaccine manufacturer in Lansing, Mich. Prior to Bioport, she served as director of quality services at over-the-counter and nutritional products makers Perrigo Co. and Leiner Health Products, Inc. Prior to that, she spent over a decade overseeing quality assurance at Miles Inc.'s Cutter Biological in Covina, Calif.
She is a member of the American Society for Quality (ASQ), American Society of Microbiology and the American Chemical Society. She received her Bachelor of Science degree in biology at Cal Poly State University, San Luis Obispo, Calif., and is ASQ certified as a quality auditor and quality engineer.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company uses its experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce active immunotherapy product candidates to potentially stimulate a cell-mediated immune response. PROVENGE (sipuleucel-T) is Dendreon's lead active cellular immunotherapy in Phase 3 development for prostate cancer. The Company also discovered Trp-p8, a cold receptor and transmembrane ion channel in pre-clinical development, which is over-expressed in breast, prostate, lung and colon cancers. 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 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 differences include risks related to our limited operating history, risks associated with completing our clinical trials, 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, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our 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, which are available at www.sec.gov.
Dendreon CorporationCONTACT: Monique M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, +1-206-829-1500
Web site: http://www.dendreon.com//
