Chiron and DepoTech complete new drug application for DepoCyt.EMERYVILLE, Calif. and SAN DIEGO--(BW HealthWire)--April 30, 1997--Chiron Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CHIR CHIR Chiricahua National Monument (US National Park Service) ) and DepoTech Corporation (NASDAQ:DEPO DEPO Delegated Episcopal Pastoral Oversight DEPO Devils Postpile National Monument (US National Park Service) DEPO Defence Export Promotion Organization (Pakistan) DEPO Double Even Pass Odd ) today announced completion of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) submission to 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. ) for DepoCyt(TM), an anti-cancer agent for use in patients with neoplastic meningitis (NM). DepoCyt is an injectable sustained-release formulation of the chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, , cytarabine. NM occurs when metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma from solid tumors, leukemia, or lymphomas spread to the tissue surrounding the brain and spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column. . Of the approximately 65,000 cancer patients in the U.S. who are afflicted with NM each year, the majority have NM arising from solid tumors. The NDA filing includes safety data for NM arising from solid tumors, leukemia and lymphomas and efficacy data for NM arising from solid tumors. DepoTech and Chiron are in the process of preparing supplemental efficacy information based on available data from leukemia and lymphomas patients. "We are pleased to have collaborated with DepoTech on the submission of the NDA for DepoCyt in this patient population, and look forward to working with DepoTech and the FDA on its review," said Magnus Lundberg, president of Chiron Therapeutics. "Chiron is committed to the rapid commercialization of DepoCyt, and we believe that additional clinical trials already underway will further support the product's impact on the course of NM." "Current modalities for treating NM are limited," said Edward L. Erickson, president and chief executive officer of DepoTech. "We believe that the data submitted in the NDA support our view that DepoCyt represents a promising advance in the treatment of this terrible disease." Chiron and DepoTech are continuing to examine DepoCyt in NM arising from leukemia and lymphomas in controlled clinical trials. A multi-center Phase IV study of DepoCyt for the treatment of NM arising from solid tumors in the U.S. and Canada has been initiated as have clinical trials of DepoCyt in Europe. A Phase I pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. dose-finding study is underway for NM arising from solid tumors, leukemia and lymphomas. Chiron Corporation, headquartered in Emeryville, California, near San Francisco, is a science-driven, market-directed healthcare company that combines diagnostic, vaccine and therapeutic strategies for controlling disease. Chiron participates in four global markets: diagnostics including immunodiagnostics, critical care diagnostics, and new quantitative probe tests; pediatric and adult vaccines; therapeutics, with an emphasis on oncology and infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. ; and ophthalmic surgical products for the correction of vision. Chiron also has research programs underway in gene therapy and gene transfer, combinatorial chemistry, cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and critical care. DepoTech is a drug delivery company dedicated to the development and manufacture of innovative, sustained-release therapeutic products based on DepoFoam(TM) technology. Products are being developed to treat medical needs in fields such as cancer, infectious diseases, pain management and rheumatologic diseases. Note: This news release may contain forward-looking statements regarding programs for DepoCyt. Actual results could differ materially from those described in this news release as a result of a number of factors, including, but not limited to the following: There can be no assurance that any product in the DepoTech product pipeline will be successfully developed or manufactured, or that final results of human clinical trials will be supportive of regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of these products will be achieved. Neither Chiron nor DepoTech undertakes any obligation to revise or update the statements in this press release to reflect events or circumstances after the date of this release. CONTACT: Chiron Corporation Larry Kurtz, 510/923-2476 Kimberly Sankaran, 510/923-2412 or DepoTech Corporation Edward L. Erickson, 619/625-2424 or StratiPoint Group Mike Jackman, 415/388-3216 |
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