CHIR Chiron (MM)

Chiron Corporation (NASDAQ:CHIR) -- Development of Next-Generation Influenza Vaccine Could Improve Annual Vaccine Production Process and Contribute to Long-Term Pandemic Preparedness -- -- Second Phase III Study in Europe Completes Enrollment -- Chiron Corporation (NASDAQ:CHIR) today announced that it has initiated a Phase I/II study of an investigational cell culture-derived influenza vaccine in the United States. Cell culture-derived influenza vaccine (commonly referred to as "flu cell culture" vaccine) represents the next generation of influenza vaccine, both for annual vaccine production and for long-term pandemic preparedness. Production of influenza vaccine using cell-culture technology may offer significant advantages over traditional manufacturing methods by eliminating the dependence on chicken eggs for production. The removal of egg supply lead times would enable flexible and faster start-up of vaccine production in the event of an annual vaccine supply shortfall or an avian influenza pandemic. The company has also completed enrollment of a second Phase III study of investigational flu cell culture vaccine in Europe. A first pivotal Phase III study of flu cell culture vaccine in Europe, conducted in 2004, met the safety and immunogenicity endpoints of the study. "Chiron is an industry leader in developing flu cell culture, and we are committed to supporting public health authorities globally by working to make this next-generation vaccine available, both for prevention of annual influenza and as an important platform for pandemic preparedness," said Dan Soland, president of Chiron Vaccines. "In addition to our return of FLUVIRIN(R) influenza virus vaccine to the U.S. annual influenza vaccine market, Chiron has several programs underway to enhance our capability to help protect people from the threat of influenza. Flu cell culture, along with our research on avian pandemic influenza vaccines and adjuvants, could contribute to a flexible and cutting-edge infrastructure to meet current and future influenza threats and help save lives." Chiron's flu cell culture vaccine is produced from virus propagated in the Madin-Darby Canine Kidney (MDCK) cell line. The company filed an investigational new drug application (IND) for flu cell culture vaccine in the United States last year, after regaining its U.S. rights to the technology. The investigational vaccine is produced at Chiron's state-of-the-art flu cell culture vaccine manufacturing facility in Marburg, Germany. "Moving from egg-based to cell-based influenza vaccine production is an important step in enhancing our preparedness against pandemic influenza and provides flexibility in meeting surges in influenza vaccine demand," said Walter A. Orenstein, M.D., professor of medicine of pediatrics and associate director of the Emory Vaccine Center in Atlanta, Georgia. "This effort will help address the challenge of responding to a pandemic." 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 about Chiron, please visit www.chiron.com. This news release contains forward-looking statements, including statements regarding development plans for influenza cell culture vaccine, likelihood of regulatory approvals, improvements to manufacturing facilities, product development initiatives, and product marketing, which involve risks and uncertainties and are subject to change. A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements, is contained in documents the company has filed with the SEC, including the Form 10-K for the year ended December 31, 2004, and the Form 10-Q for the quarter ended June 30, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including, among others, the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, litigation, stock-price and interest-rate volatility, marketing effectiveness, and the severity of the 2005-2006 influenza season. In particular, there can be no assurance that Chiron's flu cell culture vaccine will be successfully developed and then approved by U.S., European or other regulatory agencies or that additional issues with respect to influenza vaccines or Chiron's manufacturing generally will not arise in the future, or that Chiron will be able to market such new products or achieve market acceptance for such new products. The company may face additional competition in the influenza market in the future and challenges in distribution arrangements as a result of vaccine developments. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, regulatory approvals and the integration of operations. Chiron does not undertake an obligation to update the forward-looking information the company is giving today. NOTES: Chiron's investigational flu cell culture vaccine has not been approved by U.S., European or other regulatory agencies. FLUVIRIN is a registered trademark of Chiron.