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Phase III Trial Initiated for Meningococcal C Vaccine
EMERYVILLE, Calif., April 16 /PRNewswire-FirstCall/ -- Chiron Corporation today announced that it has initiated a Phase III trial in the United States for Menjugate™, the company's conjugated vaccine for the prevention of meningococcal C disease. The study, which is being conducted in conjunction with the Northern California Kaiser Permanente Vaccines Research Center, will expand the vaccine's safety database for a U.S. population relative to the safety profile of the current U.S.-licensed meningococcal polysaccharide vaccine Menomune® (A, C, Y, W-135).
"Bringing Menjugate to the United States would help physicians and families prevent one of this country's most common forms of meningococcal disease, meningitis and septicemia (bloodstream infection) caused by meningococcal C infection," said John Lambert, president of Chiron Vaccines. "This is an important step in fulfilling Chiron's commitment to reduce the toll from meningococcal disease through the development of vaccines to address the five key serogroups that cause it."
"In meningococcal disease, prevention is essential," said Steve Black, M.D., co-director of the Kaiser Permanente Vaccine Study Center and lead investigator of the Chiron-Kaiser study, "because even when infection is diagnosed and treated promptly, it can still be fatal in up to ten percent of cases. By inducing immunological memory that confers long-lasting protection, a conjugate vaccine for serogroup C could bring valuable benefits to U.S. prevention efforts."
In universal vaccination campaigns in the United Kingdom and Quebec, Menjugate™ vaccine has helped reduce deaths from meningococcal C disease by approximately 80 percent. The vaccine is currently approved for use in infants through adults in 25 countries worldwide.
Meningococcal disease is primarily caused by five serogroups of Neisseria meningitidis: A, B, C, Y and W-135. Three thousand cases of meningococcal meningitis and bloodstream infection are reported annually in the United States. The fatality rate from the disease is 10 to 15 percent. Among survivors, an additional 11 to 19 percent have significant sequelae, including neurologic disability, limb loss, or hearing loss. An estimated 150 million people worldwide would benefit from preventative vaccines against meningococcal disease.
Chiron has vaccines in development for serogroups A, B, C, Y and W-135, the five most common meningococcal serogroups known to cause human disease. In addition to serogroup- and strain-specific vaccines, Chiron has a combination vaccine against serogroups A, C, Y and W-135 in development. The company is currently evaluating data from the completed Phase I trial for this vaccine.
Chiron Corporation, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company commercializes its products through three business units: biopharmaceuticals, vaccines and blood testing. 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 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-K for the year ended December 31, 2002, 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 activity 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 is 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.
NOTE: Menjugate is a trademark of Chiron Corporation. Menomune is a trademark of Aventis Pasteur Inc.