Dendreon Receives Orphan Drug Status From FDA for Mylovenge for Treating Multiple Myeloma.Health & Medical Writers SEATTLE--(BUSINESS WIRE)--April 24, 2002 Dendreon Corporation (Nasdaq:DNDN) announced today that the company's therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. for 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 , Mylovenge(TM), has been granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status by the U.S. Food and Drug Administration (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. ). Orphan drug designation by the FDA is designed to encourage research and development of new therapies for diseases that affect fewer than 200,000 people in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . In receiving orphan drug status for Mylovenge, Dendreon is eligible for tax credits for related clinical development costs and assistance from the FDA to facilitate the regulatory review and approval process. "We are pleased to receive orphan drug status for Mylovenge and continue our ongoing efforts to explore the utility of this vaccine for treating B-cell malignancies such as multiple myeloma," said David Urdal, Ph.D., president and chief scientific officer of Dendreon. Mylovenge is currently in Phase II clinical trials. Preliminary results of two recently completed clinical trials suggest that Mylovenge treatment is safe, and that it may stimulate immune activity and cause disease regression or stabilization. About Multiple Myeloma Multiple myeloma is a cancer of the blood characterized by the spread of cancerous B-Lymphocytes that lead to damage to normal cells and bone. Current treatments for multiple myeloma include chemotherapy and bone marrow transplant bone marrow transplant: see bone marrow. . More than 40,000 Americans currently have multiple myeloma. The American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimates that over 14,000 new cases of multiple myeloma will be diagnosed in 2002 in the United States and nearly 11,000 individuals will die from the disease. About Dendreon Dendreon Corporation is dedicated to the discovery and development of novel products for the treatment of cancer through its innovative manipulation of the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . In addition to Mylovenge, Dendreon has two other therapeutic cancer vaccine candidates in clinical trials -- Provenge(TM), 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. , in Phase III trials; 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 and colon cancers, in Phase I trials. Dendreon's product pipeline also includes monoclonal antibodies and a pathway to small molecules. For more information, visit www.dendreon.com. 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 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, 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 will not 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, dependence on the efforts of third parties, 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 (SEC), which are available at www.sec.gov. |
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