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Title: Menactra(TM) Vaccine Available for Meningitis Prevention in Canada

"Menactra(TM) Vaccine Available for Meningitis Prevention in Canada"

First conjugate vaccine to protect against multiple strains of rapid, life-threatening disease TORONTO, CANADA -- January 9, 2007 -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, announced today that Menactra™ (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), the first quadrivalent conjugate vaccine for prevention of invasive meningococcal disease (meningitis), is now available in Canada. Menactra™ will offer broad protection against all four vaccine-preventable strains of bacteria that cause invasive meningococcal disease (A, C, Y, and W-135). Current meningococcal conjugate vaccines only provide strain C protection, leaving children and adolescents with incomplete protection. "Over the years, Canada has witnessed a concerning change in the distribution of strains of meningitis leaving many vulnerable to the emergence of strains not covered by earlier conjugate vaccines," said Dr. Dion Neame, Chief of Pediatrics, Joseph Brant Memorial Hospital and Medical Advisor for the Meningitis Research Foundation. "Menactra™ will provide essential broad protection from this devastating disease for our children, adolescents, and adults at risk." The epidemiology of invasive meningococcal disease (IMD), one of the most devastating diseases in Canada, has been changing across the country over recent years with an increasing proportion of strains Y and W-135 being observed. These strains now comprise 32% of IMD in Canada according to most recent data. In Ontario (2003), the most current data indicates vaccine preventable strains C, Y, and W-135 comprise 64% of IMD cases. The Grassie family of Keswick, Ontario, experienced first-hand the devastation meningitis can cause unexpectedly, when 9-year old Keaton was diagnosed with invasive meningococcal disease caused by strain Y in July 2005. While Keaton was fortunate to survive the disease, it resulted in the necessary amputation of his legs. "As a parent personally affected by meningococcal disease, I want other parents to be aware of the disease and that their children can be protected," said Keaton's mother, Katie Grassie. "This is a terrible disease that can affect anyone, anywhere, and with tragic consequences. My hope is that no other family has to go through this experience. I wish we'd had the choice." Meningococcal disease is a rare but serious bacterial infection that strikes approximately 300 individuals in Canada annually with children under five years, people aged 16 to 24 and those over 55 most commonly affected. Approximately 10 per cent of individuals who contract meningococcal disease will die. Of those who survive, up to one in five suffer permanent disabilities such as hearing loss, neurological damage and limb amputations. Meningococcal disease often begins with symptoms that can be mistaken for common viral illnesses, such as the flu. But unlike more common infections, meningococcal disease can progress very rapidly and kill an otherwise healthy young person in 48 hours or less. "The Meningitis Research Foundation of Canada advocates for prevention," said Kathryn Blain, founder of the Foundation and a mother who lost her son to the disease. "Given the susceptibility of children and adolescents who currently have incomplete protection, we strongly believe Menactra™ should be given to this group as part of routine visits to save more lives and prevent disability." About Menactra™ Manufactured by sanofi pasteur, the vaccines business of the sanofi-aventis Group, Menactra™ is indicated for active immunization of individuals two to 55 years of age for prevention of invasive meningococcal disease (IMD) caused by all four vaccine-preventable serogroups of Neisseria meningitidis (A, C, Y, W-135). In the U.S., since its introduction in March 2005, more than 6.6 million doses of Menactra™ have been distributed for routine vaccination of adolescents. Health Canada granted an expedited review of Menactra™ and issued a Notice of Compliance based on immunogenicity and safety data from six pivotal studies, which included more than 10,000 individuals who received Menactra™. Menactra™ induced the production of functional antibodies specific to the capsular polysaccharides of the four serogroups (A, C, Y and W-135) found in the vaccine. All vaccine immunogenicity measurements demonstrated strong immune responses to a single dose of Menactra™ vaccine. It was found to be well tolerated in all age-groups. The most common adverse reactions to Menactra™ vaccine may include pain, redness, and induration at the site of injection, headache, fatigue and malaise. Menactra™ vaccine is contraindicated in persons with a known hypersensitivity to any component of the vaccine or to latex, which is used in the vial stopper, and in persons with a known history of Guillain-Barré syndrome. SOURCE: sanofi-aventis

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