Chiron FLUVIRIN Vaccine License Reinstated by UK Regulatory Agency.EMERYVILLE, Calif. -- 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 Will Monitor Ongoing Remediation Progress; Chiron Expects Full 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. cGMP Inspection Chiron Corporation (Nasdaq:CHIR CHIR Chiricahua National Monument (US National Park Service) ) today announced that it has received notice from 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) that the agency has lifted the license suspension for Chiron's Liverpool manufacturing facility, which produces 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. . The notice, which follows MHRA inspections of the Liverpool facility, states that "it is the opinion of the Licensing Authority that (Chiron is) now in a position to conduct (its) operations in accordance with the principles and guidelines of Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. )." The decision is conditioned on the understanding that Chiron's high level of commitment to the completion of its remediation plan and ongoing improvements will continue. Chiron will provide the MHRA with regular weekly updates to ensure that progress on its various projects proceeds satisfactorily, and the MHRA may conduct further inspections. Chiron now has clearance to initiate full production of FLUVIRIN vaccine. "We are grateful for the guidance and effort from the regulatory agencies as we have navigated a path toward remediation," said Howard Pien, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Chiron. "Our employees have worked tirelessly and we are extremely proud of this result. This is a significant accomplishment. In this new beginning we remain focused on continuing to remediate and improve so Chiron can successfully deliver on the results required to supply influenza vaccine influenza vaccine Flu vaccine A vaccine recommended for those at high risk for serious complications from influenza: > age 65; Pts with chronic diseases of heart, lung or kidneys, DM, immunosuppression, severe anemia, nursing home and other chronic-care for the 2005-2006 season." Chiron anticipates that the U.S. Food and Drug Administration (FDA) will conduct a full cGMP inspection to allow resolution of the warning letter issued in December 2004. 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. This news release contains forward-looking statements, including statements regarding our delivery of FLUVIRIN in the 2005-2006 influenza season and our ability to continue to maintain our manufacturing operations in compliance with principles of cGMP. 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. 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 and/or actions taken by the UK Medicines and Healthcare Products Regulatory Agency, U.S. Food and Drug Administration, 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, competition and 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. , 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 approval by Novartis, 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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