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FDA denies priority review for Cervarix

Executive Summary

GlaxoSmithKline's BLA for Cervarix gets 10-month standard review, setting a January 2008 user fee date for the human papilloma virus vaccine, which was submitted March 29. The decision gives Merck additional time to establish Gardasil, which began sales in June 2006, as the only vaccine on the market to prevent human papilloma virus infection and associated diseases, such as cervical cancer. GSK hopes to position Cervarix as a superior product; a head-to-head trial comparing Cervarix to Gardasil is ongoing (1"The Pink Sheet" April 2, 2007, In Brief)...

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GSK files Cervarix BLA

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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