Chiron Anticipates a Series of Regulatory Inspections for Remediation of Liverpool Manufacturing Facility.EMERYVILLE, Calif. -- Presentation at JPMorgan Healthcare Conference Provides Update on FLUVIRIN(R) influenza virus vaccine influenza virus vaccine n. A vaccine containing influenza virus, usually several strains of the virus, prepared in chick embryos and used to immunize against influenza. Chiron Corporation (Nasdaq:CHIR CHIR Chiricahua National Monument (US National Park Service) ) announced today at a presentation at the 23rd Annual JPMorgan Healthcare Conference that the company anticipates that the UK Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. (MHRA MHRA Medicines and Healthcare Products Regulatory Agency MHRA Modern Humanities Research Association (United Kingdom) MHRA Minnesota Human Rights Act MHRA Malta Hotels and Restaurants Association ), accompanied by 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. ) inspectors as observers, will conduct a series of inspections of Chiron's Liverpool manufacturing facility. The inspections will cover critical phases of the manufacture of FLUVIRIN(R) influenza virus vaccine. With this regulatory process, the remediation effort may advance toward the restoration of the facility's license, as successive phases of manufacturing pass inspection by the MHRA. Chiron would receive sequential clearances to operate in certain areas as remediation continued in others. Assuming successful completion of these inspections and restoration of the facility's license, Chiron would expect a subsequent full cGMP (current Good Manufacturing Practices) inspection by the FDA to close out the FDA warning letter issued December 9, 2004. Chiron's JPMorgan presentation may be viewed at www.chiron.com/webcast. A replay of the presentation is accessible at www.mapdigital.com/jpmorgan/healthcare05/. About Chiron Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information, please visit www.chiron.com. About Chiron Vaccines Chiron Vaccines, the world's fifth-largest vaccines business, is headquartered in Oxford, United Kingdom, and has facilities located throughout Europe, the United States and Asia. In addition to influenza vaccines, Chiron Vaccines has important meningitis, 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. and travel vaccine franchises. Chiron Vaccines is a leading vaccine manufacturer in the United Kingdom, Germany and Italy. The company's portfolio of products includes vaccines for influenza, meningitis C, rabies, tick-borne encephalitis encephalitis (ĕnsĕf'əlī`təs), general term used to describe a diffuse inflammation of the brain and spinal cord, usually of viral origin, often transmitted by mosquitoes, in contrast to a bacterial infection of the meninges , yellow fever, haemophilus influenzae B (Hib), polio, mumps, measles and rubella rubella or German measles, acute infectious disease of children and young adults. It is caused by a filterable virus that is spread by droplet spray from the respiratory tract of an infected individual. (MMR MMR measles-mumps-rubella (vaccine); see measles, mumps, and rubella vaccine live, under vaccine. MMR abbr. measles, mumps, rubella vaccine ) and diphtheria, tetanus and pertussis pertussis: see whooping cough. (whooping cough). This news release contains forward-looking statements, including statements regarding restoration of Chiron's Liverpool manufacturing license, resolution of issues noted in the FDA's warning letter and the supply of FLUVIRIN(R) influenza virus vaccine that Chiron expects to deliver to the U.S. market in future influenza seasons. These forward-looking statements involve risks and uncertainties and are subject to change. No assurances can be given that additional issues with respect to FLUVIRIN or Chiron's manufacturing generally will not arise in the future or that the MHRA will restore Chiron's FLUVIRIN license. During the period of inspections, the MHRA may again notify Chiron of a proposed continuation of the suspension of Chiron's license to manufacture influenza vaccines in Liverpool, beyond the additional three-month suspension that took effect January 4, 2005. Many factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements, including, among others, additional adverse developments resulting from investigations or discussions with or actions taken or required by the MHRA, FDA, U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS , or U.S. Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. . In addition, a full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-Q for the quarter ended September 30, 2004, and the form 10-K for the year ended December 31, 2003, and will be contained in all subsequent periodic filings made with the SEC. These documents identify other important factors that could cause the company's actual performance to differ from the expectation expressed or implied by these forward-looking statements, including, regulatory review and approvals, manufacturing capabilities, pricing pressures, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , stock-price volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will timely maintain anticipated levels of profitability, increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. In addition, the company may engage in business opportunities, the successful completion of which are subject to certain risks, including shareholder and regulatory approvals and the integration of operations. We do not undertake an obligation to update the forward-looking information we are giving today. NOTE: FLUVIRIN is a trademark of Chiron Corporation. |
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