CHIR Chiron (MM)

Chiron Begins Phase III Trial for Tifacogin Multicenter, International Trial Will Study Efficacy in Treatment of Severe Community-Acquired Pneumonia EMERYVILLE, Calif., May 18 /PRNewswire-FirstCall/ -- Chiron Corporation announced today that it has initiated a Phase III trial for tifacogin as a treatment for severe community-acquired pneumonia (severe CAP). Severe CAP is defined as pneumonia contracted outside of a hospital setting that requires the patient's admission to an intensive-care unit. Tifacogin, developed by Chiron, is a recombinant form of tissue factor pathway inhibitor, or TFPI, a naturally occurring protein in the body. "The mortality rate associated with severe CAP has remained constant for the past 50 years in spite of significant advances in antibiotic therapy. We believe that tifacogin has the potential to impact this significant unmet medical need," said Dr. Stephen Dilly, chief medical officer of Chiron BioPharmaceuticals. "Tifacogin for severe CAP is an excellent fit with our emerging franchise in serious pulmonary conditions. We have a strong scientific and clinical rationale for this study, which we believe is the right study at the right time for tifacogin." The Phase III study, called CAPTIVATE, is a randomized placebo-controlled study. The study comprises three treatment arms: placebo, low-dose tifacogin and higher-dose tifacogin. The study is expected to accrue approximately 2,100 patients in 200 centers in 16 countries worldwide. The primary endpoint of the study is reduction in mortality at 28 days. Severe CAP affects approximately 300,000 patients in the United States annually. Approximately 30 percent of patients with severe CAP die. Current therapy includes routine antibiotics and supportive care. No adjunctive drugs are currently approved for the reduction of mortality in severe CAP. About Chiron Through its global Blood Testing, Vaccines and BioPharmaceuticals businesses, Chiron Corporation addresses human suffering with more than 50 diverse products to detect, prevent and treat disease worldwide. The company's consistent success has come from its pioneering science, skill in delivering innovations in biotechnology and disciplined business approach. Chiron believes that science has the power to improve people's lives and harnesses that power to transform public health. This year, Chiron Vaccines celebrates 100 years of advancing medicine with the anniversary of two founding companies. In 1904, Emil von Behring and Achille Sclavo independently started companies in Germany and Italy, respectively, dedicated to the research, development and manufacture of vaccines to protect humanity from infectious disease. As the fifth-largest vaccine manufacturer in the world, Chiron remains dedicated to the legacies of von Behring and Sclavo to prevent disease and develop new vaccines to improve human health globally. For more information about Chiron, visit the company's website at http://www.chiron.com/. This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives, new product indications, new product marketing, acquisitions, and in- and out-licensing activities that involve risks and uncertainties and are subject to change. 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 ending March 31, 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 important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activities will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. 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. Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today. DATASOURCE: Chiron Corporation CONTACT: Chiron Corporate Communications & Investor Relations, media, +1-510-923-6500, or investors, +1-510-923-2300 Web site: http://www.chiron.com/

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