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GSK files Cervarix BLA

Executive Summary

GlaxoSmithKline requests a priority review of its human papillomavirus vaccine Cervarix BLA, filed March 29. The submission is based on data from clinical trials in almost 30,000 females ages 10 to 55; one trial showed that Cervarix induced high antibody levels and more robust immune memory response when formulated with its proprietary AS04 adjuvant system, aluminum hydroxide plus MPL (monophosphoryl lipid A), than with aluminum hydroxide alone. GSK is looking to position Cervarix as superior to Merck's HPV vaccine Gardasil, which is formulated with aluminum hydroxide. Gardasil has been on the market since June (1"The Pink Sheet" June 12, 2006, p. 3)...

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