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Merck Gardasil BLA

Executive Summary

Merck plans to submit a BLA for its human papilloma virus vaccine Gardasil by the end of 2005 following release of the first Phase III results Oct. 6. Primary analysis of the FUTURE II trial found 100% efficacy against HPV types 16 and 18-related cervical pre-cancers (cervical intraepithelial neoplasia grades 2 and 3) and non-invasive cancers (adenocarcinoma in situ) in women ages 16 to 26 receiving a three-vaccine series. The vaccine was 97% effective in a secondary analysis that included women who violated protocol...

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