GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix

PHILADELPHIA, PA, March 15, 2005 GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine candidate, BoostrixTM [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received a unanimous favorable recommendation from the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA). Currently, there is no pertussis vaccine approved for use in the U.S. for children seven years of age or older. Immunity from childhood vaccination generally wears off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease. If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently recommended for adolescents. The committee's favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for Boostrix.

Reported cases of pertussis have increased since the mid-1970s. According to the Centers for Disease Control and Prevention (CDC), there were almost 20,000 cases in 2004 the highest number of reported cases in more than 40 years. In addition, 39 percent of cases reported to the CDC in 2003 occurred in adolescents 10-19 years of age. Adolescents, in whom classic signs and symptoms of pertussis are often absent, may go undiagnosed and be the source of infection for susceptible infants and other family members.

"Pertussis is a serious and growing public health threat, and we are extremely pleased that the FDA Advisory Committee has provided a unanimous favorable recommendation for FDA approval of Boostrix," said Barbara Howe, M.D., vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. "If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently administered to adolescents a population in which there is a si

Contact: Amanda Foley
Cohn & Wolfe

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