Meningococcal C Vaccine Approved in Canada
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Meningococcal C Vaccine Approved in Canada

EMERYVILLE, CA -- April 25, 2001 -- Chiron Corporation announced today that Health Canada's Bureau of Biologics and Radiopharmaceuticals (BBR) granted the company a license to market Menjugate™, 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 $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 worldwide. 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.

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 percent of the meningitis cases in the U.S. and Canada, and about 40 percent 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 percent 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.

SOURCE: Chiron Corporation

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