Dendreon To Outsource California Cell Processing Operations to Progenitor Cell Therapy.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE & HACKENSACK, N.J.--(BUSINESS WIRE)--Aug. 28, 2002 Dendreon Corporation (Nasdaq:DNDN) and Progenitor Cell progenitor cell See stem cell. Therapy, L.L.C. (Progenitor pro·gen·i·tor n. 1. A direct ancestor. 2. An originator of a line of descent. progenitor ancestor, including parent. progenitor cell stem cells. ) today announced that Dendreon will outsource its California cell processing operations to Progenitor. "We are making considerable progress at Dendreon, having recently announced promising Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA data for Provenge(TM)," said Mitchell H. Gold, M.D., Dendreon's chief business officer. "Progenitor has provided us with high quality cell processing through their Hackensack, N.J. facility, and we are confident they will continue to do so through this expanded relationship, which enables us to have the cell processing capacity we need going forward." Under terms of the agreement, Progenitor will pay a fee to Dendreon and assume operational, lease and personnel obligations for Dendreon's cell processing facility in Mountain View, Calif. Progenitor will provide cell-processing services at the facility for Dendreon as requested. Dendreon estimates that over four years the arrangement will save $10 million. "We are very enthusiastic about the recent positive data for Provenge and are pleased to have the opportunity to continue our work with Dendreon as they bring Provenge and their other product candidates closer to market," said Andrew L. Pecora, M.D., chairman and chief executive officer of Progenitor Cell Therapy. "The highly qualified cell therapy manufacturing specialists at Mountain View who are joining Progenitor will significantly enhance our ability to serve the needs of the emerging field of cell therapy," said Dr. Robert A. Preti, president and chief scientific officer of Progenitor. "This decision was made after a thorough analysis of our experiences to date in operating a Dendreon-owned facility versus contracting for services," said Martin Simonetti, chief financial officer at Dendreon. "It makes sense both financially by lowering our cost of goods and strategically in the long-term commercialization of our products." About Dendreon Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. Dendreon currently has three therapeutic vaccines in clinical trials -- Provenge, for the treatment of prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. ; Mylovenge(TM), for the treatment of multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility ; and APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. 8024, for the treatment of breast, ovarian ovarian /ovar·i·an/ (o-var´e-an) pertaining to an ovary or ovaries. ovarian pertaining to an ovary. ovarian agenesis and colon cancers. Dendreon's product pipeline also includes monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). and a pathway to small molecules. Dendreon has established important alliances with industry leaders Genentech, Johnson & Johnson Pharmaceutical Research & Development and Kirin Brewery Co., Ltd. For more information, visit www.dendreon.com. About Progenitor Cell Therapy, L.L.C. Progenitor Cell Therapy is a commercial cell engineering company that provides for the collection, manufacture, storage and redistribution of human cells for therapeutic purposes through a nationwide network, operated in compliance with current Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. . For more information, visit www.progenitorcelltherapy.com. Dendreon's Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement 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 relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc our dependence on the efforts of third parties, including Progenitor Cell Therapy, 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 Dendreon's limited operating history, risks associated with completing Dendreon's clinical trials, including the resumption of enrollment in Dendreon's ongoing Phase III Provenge clinical trial, the risk 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. will not be satisfied with the data we provide for Provenge or approve a product for which a biologics license has been applied, the uncertainty of Dendreon's future access to capital, the failure by Dendreon to secure and maintain relationships with collaborators, and 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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