Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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HAV and HBV affect almost every urban and rural community and are among the most common infectious diseases in the world. Both represent serious public health problems: there are, worldwide, an estimated 1.4 million cases of HAV per year and 300 million-350 million chronic carriers of HBV.
Twinrix is the second SB vaccine to receive approval from the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA). The Community decision, granting European marketing authorization, is expected to be published in the Official Journal in the next few weeks.
The regulatory action pertains to the Twinrix formulation for individuals age 15 or older. Pricing approvals must still be obtained in certain countries under routine regulation. A Twinrix formulation for children and adolescents is currently awaiting EMEA approval.
Jean Stephenne, Senior Vice President and General Manager of SB Biologicals, commented: "Twinrix will offer significant advantages including increased convenience for the physician and the patient, fewer injections and better compliance compared with two separate vaccination courses. Travelers to high endemicity areas, individuals at risk through their lifestyle, as well as military and exposed healthcare personnel, represent priority target groups for hepatitis A+B immunization. In the longer term, Twinrix will facilitate the universal vaccination of children and adolescents against hepatitis. This is of particular significance as a growing proportion of this population segment is becoming susceptible to hepatitis A."
SmithKline Beecham, with vaccine research and development based in Belgium, is one of the world's leading vaccine manufacturers. The company discovers, develops, manufactures and markets pharmaceuticals, vaccines, over- the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management.
CONTACT: Media, Richard Koenig, 215-751-3415, or Investor Relations, Richard Williams, 215-751-7002, both of SmithKline Beecham
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