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Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an overview of the clinical trial program for V503, the company’s investigational 9-valent human papillomavirus (HPV) vaccine, to the Advisory Committee on Immunization Practices in the United States. 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 U.S. Food and Drug Administration in 2013.
The study evaluated the efficacy, immunogenicity and safety of V503 in females 16-26 years of age. Merck plans to present results from this study, as well as other results from the Phase III clinical program for V503, at the EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) congress in November.
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This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.