Healthcare Industry News: sipuleucel-T
News Release - March 7, 2006
Dendreon Names Ernest Bognar General Manager of Hanover, NJ Manufacturing FacilitySEATTLE, March 7 (HSMN NewsFeed) -- Dendreon Corporation (Nasdaq: DNDN ) today announced that it named Ernest A. Bognar general manager of the Company's new manufacturing facility in Hanover, New Jersey. Dendreon is currently developing this facility to meet the anticipated clinical and commercial manufacturing needs for PROVENGE® (sipuleucel-T) and its other active immunotherapy product candidates in development. PROVENGE is the Company's lead investigational active cellular immunotherapy for the potential treatment of advanced prostate cancer.
"Ernie brings to Dendreon over two decades of experience in clinical and commercial grade biopharmaceutical manufacturing ranging from bulk production to final fill and finish operations for a broad range of biotech products," said Andy Scherer, vice president of manufacturing. "We're so pleased to have someone with his background and expertise managing our facility as we complete the build-out of the site and prepare for the pre-BLA inspection by the FDA and commercial production of PROVENGE."
PROVENGE has Fast Track designation and the Company plans to begin submitting its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) 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.
Bognar recently served as vice president of manufacturing at Apptec Laboratory Services where he was brought on board to manage and grow a mammalian cell-based contract manufacturing business unit. Prior to that, he was senior director commercial manufacturing for ImClone Systems Inc., where he managed a biopharmaceutical start-up operation that produced the company's monoclonal antibody, ERBITUX® (cetuximab) Injection for the treatment of colorectal cancer. Previously, he served as director of operations at Baxter Healthcare's Hyland-Immuno Division where he managed a commercial biopharmaceutical operation producing a licensed recombinant protein for the treatment of hemophilia. Bognar also held key manufacturing positions at Cellex Biocences & Verax, Charles River Biotech & KC Biological and Ayerst Research Laboratories.
He received his Bachelor's of Science degree in in vitro cell biology from the State University of New York of Arts and Sciences at Plattsburgh and his Cell Biology Certificate from W. Alton Jones Cell Science Center in Lake Placid, NY.
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.
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