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PR Newswire, London, April 25. This press release is transmitted on behalf of Chiron Corporation.

Menjugate meningococcal C conjugate vaccine approved under expedited review

Emeryville, California -

Chiron Corporation (Nasdaq: CHIR) announced today that Health Canada's Bureau of Biologics and Radiopharmaceuticals (BBR) granted the company a license to market Menjugate(TM), a conjugate vaccine against disease caused by the bacterium Neisseria meningitidis serogroup C (MenC).

Health Canada's BBR approved Menjugate under expedited review, for use in vaccinating all age groups including infants from two months of age through adults for prevention of meningococcal C disease. This action was prompted by reported increases in this disease in several Canadian provinces. Merck Frosst will be the exclusive distributor of Menjugate in Canada, and will support and promote sales to the public and private sectors. Menjugate is a conjugate vaccine comprised of purified capsular polysaccharide conjugated to a protein carrier. Menjugate was first licensed in the United Kingdom (UK) in March 2000, with US Dollars 115 million in sales in 2000 from shipments to the UK, Ireland, Hungary, and Spain.

"Chiron is focused on fully developing the potential of Menjugate to prevent meningococcal C outbreaks world-wide. The approval of Menjugate in Canada broadens the market for Chiron's MenC franchise beyond Europe. Chiron is applying for registration throughout Europe by means of the Mutual Recognition Procedure. Additionally, Chiron is in negotiations with public health authorities in other countries where meningococcal C disease outbreaks occur," commented John Lambert, president of Chiron Vaccines.

Chiron's meningococcal franchise

Chiron is committed to the development of vaccines for the prevention of meningococcal disease, including disease caused by serogroups A, B, C, W and Y. The lead research program is a vaccine for Meningococcal B disease and clinical trials are targeted to begin in 2001-2002.

Meningococcal Meningitis: A deadly disease

Invasive infection with the bacterium N. meningitidis can lead to meningitis and septicemia (blood poisoning). Meningococcal meningitis, which can be caused by multiple serogroups (A, B, C, Y and others), is associated with a high mortality rate. Of these strains, serogroup C accounts for approximately 25 to 45 per cent of the meningitis cases in the U.S. and Canada, and about 40 per cent in the UK. Meningococcal meningitis outbreaks tend to be seasonal, with the highest incidence in the winter months. Symptoms of this deadly infection mimic those of the flu and include: fever, headache, vomiting, stiff neck, and a rash of small red spots, which subsequently develop into bruises, blood blisters, or blood spots. Of patients who do recover from the disease, 10% have permanent hearing loss or other serious complications.

"The existing meningococcal polysaccharide vaccine does not provide significant protection for those under 2 years of age, nor is the protection long lasting in those over 2 years of age. In contrast, the meningococcal C conjugate vaccine is protective even in children under 2 years of age and provides a long lasting effect. In addition, unlike the polysaccharide vaccine, in which we demonstrated immunologic hyporesponsiveness of the C component to subsequent doses of polysaccharide, the conjugate vaccine is immunogenic even in subjects who previously received polysaccharide vaccine," commented Dr. Noni MacDonald, Professor of Paediatrics and Microbiology, Dalhousie University School of Medicine, Halifax, Nova Scotia.

Prevalence of meningococcal meningitis in Canada

Since January 2001, an increase in Men C disease has been reported in several Canadian provinces. According to Health Canada, the annual number of cases of invasive meningococcal disease varies from 150 to 300 cases with local and regional outbreaks occurring in irregular cycles. Approximately 7 to 10 per cent of cases are fatal. Between 1997 and 1998 at least 13 Canadians died of group C invasive meningococcal disease. During this past winter, numerous outbreaks have been reported in Canada, mainly in British Columbia, Alberta, Manitoba, Ontario and Quebec.

About Chiron Vaccines

Chiron Vaccines sells a pipeline of novel and standard vaccines, primarily in Europe. Chiron Behring (Germany) and Chiron S.p.A. (Italy) are leaders in their respective vaccine markets. Chiron also sells its vaccines internationally through multinational healthcare organizations and local distributors.

About Chiron

Chiron Corporation, headquartered in Emeryville, California, is a leading biotechnology company that participates in three global healthcare markets: biopharmaceuticals, vaccines, and blood testing. The company is applying an integrated scientific approach to the development of innovative products for preventing and treating cancer and infection. For more information about Chiron, visit the company's Web site at

This news release contains forward-looking statements that involve risks and uncertainties. A full discussion of Chiron's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company files with the SEC, such as forms 10-Q and 10-K. 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, manufacturing capabilities and marketing effectiveness.

In line with the new SEC Rule FD, Chiron Corporation does not undertake an obligation to update the forward-looking information we are giving today.

Note: Menjugate is a trademark of Chiron Corporation.
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Publication:PR Newswire
Date:Apr 25, 2001
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