Merck & Co's investigational HPV vaccine shows broader efficacy than Gardasil

4 November 2013

US pharma giant Merck & Co (NYSE: MRK) has revealed an overview of its clinical trial program for V503, its investigational nine-valent human papillomavirus (HPV) vaccine, to the Advisory Committee on Immunization Practices in the USA.

Merck said that the pivotal efficacy trial is complete, the primary endpoints have been met and the company expects to submit a Biologics License Application for V503 to the US Food and Drug Administration by the end of the year.

The study evaluated the efficacy, immunogenicity and safety of V503 in women and girls aged 16-26. The Wall Street Journal reported on Sunday that Merck said the experimental vaccine appeared to provide broader protection against HPV than Merck’s already-licensed quadrivalent HPV vaccine Gardasil. This efficacy study points the way for the company to eventually replace Gardasil with its new vaccine. Analysts quoted by the WSJ said annual sales could exceed $1 billion.

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