To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Neisvac-C (Meningococcal Group C - Tetanus Toxoid Conjugate) Vaccine For Meningococcal C Meningitis Approved In Canada URL: http://www.pslgroup.com/dg/21219E.htm Doctor's Guide January 14, 2002
LAVAL, QC -- January 14, 2002 -- Shire Biologics, part of Shire Pharmaceuticals Group plc today announced approval by Health Canada for the commercialization of a new vaccine (meningococcal group C - tetanus toxoid conjugate vaccine), NeisVac-C. Based on an innovative technology discovered by the National Research Council of Canada (NRC), NeisVac-C vaccine represents NRC's first vaccine technology to be approved for marketing in this country. Shire Biologics has obtained exclusive rights from Baxter Healthcare Corporation, developer of the vaccine, for the Canadian distribution of NeisVac-C. Mr. Mauril Bélanger, Member of Parliament for Ottawa/Vanier, was present at the announcement made in Ottawa today, representing the Honourable Brian Tobin, Minister of Industry, whose responsibilities include the NRC. NeisVac-C vaccine has been shown to be highly immunogenic in infants, children, adolescents and adults against serogroup C Neisseria meningitidis. It also confers immunologic memory (long-term protection) in all age groups. In addition, NeisVac-C vaccine offers an excellent safety profile among people of all ages as well as ease of administration. This vaccine comes in a liquid formulation provided in pre-filled syringes to facilitate administration and to reduce the time required by health-care centers to vaccinate patients. NeisVac-C vaccine is indicated for the active immunization of children from two months of age and older as well as adolescents and adults for the prevention of invasive disease caused by Neisseria meningitidis serogroup C. NeisVac-C vaccine has already been approved in 13 European countries including the United Kingdom where it will be marketed by Baxter. "The approval of NeisVac-C vaccine adds an important new bacterial vaccine product to our pipeline in Canada," said Dr. Randal Chase, President of Shire Biologics. "Coupled with our recent ten-year influenza pandemic and annual influenza vaccine contract with the Canadian Government, Shire Biologics is solidly based in this country as we continue to build a strong biologics business for the Shire Pharmaceuticals Group worldwide." Mr. Bélanger expressed his satisfaction at seeing the concrete effects of Canadian innovation as a result of Government funding of the NRC. "This is an example of a technology discovered here in Canada by our own talented scientists that not only provides significant advantages in terms of health protection but can be of benefit to people all over the world," he said. "The meningococcal group C vaccine is a huge success story for the NRC, but is certainly not one that happened over night," said Dr. Arthur Carty, President of the NRC. "It was the result of decades-long research and investment demonstrating the value and need for continuous financing of long- term research projects. Dr. Joan Fusco, Baxter BioScience's Vice President, Global Project Management, Vaccines, expressed Baxter's pride at having developed the NeisVac- C vaccine, and satisfaction at seeing it approved both in Canada and in other jurisdictions. "NeisVac-C vaccine was used recently in the United Kingdom with very positive results as part of a massive vaccination program of 12 million people. We believe it will prove equally successful in Canada," she said. There has been a resurgence of meningococcal C meningitis disease beginning in January 2000, with 101 confirmed cases reported in 2000 and 87 in the first six months of 2001. Localized outbreaks, predominantly in adolescents and young adults, have been reported by five provinces (Alberta, British Columbia, Manitoba, Quebec and Ontario)(1). According to the National Advisory Committee on Immunisation (NACI), Meningitis serogroup C has "almost exclusively been responsible for clusters of outbreaks in schools and communities." Quebec has recently introduced a province-wide vaccination program against the disease for anyone 20 years of age or younger. NeisVac-C vaccine is the result of an innovative technology that conjugates a protein with the polysaccharide capsule that surrounds the meningococcal bacteria, creating a more effective vaccine. As a conjugate vaccine, it provides protection for all age groups, including infants and toddlers, who are the hardest hit by this disease. It also induces immune responses that are longer lasting than the non-conjugate meningococcal olysaccharide vaccines which have been widely used in North America for the control of outbreaks of the disease, but which, according to NACI, have lower efficacy in children 10 years of age or under and are ineffective in children who are two years of age or less. SOURCE: SHIRE BIOLOGICS --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. 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