New Ph III data shows Merck & Co's Gardasil was effective against anal disease caused by HPV 6,11,16, and 18

US drug major Merck & Co says that in new Phase III data demonstrates that Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] vaccine, recombinant) was 77.5% (95% CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men.

The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco, and could help Merck gain approval to market the vaccine for two new uses, blocking cervical cancer in women over age 26 and preventing anal cancer in homosexual men. It could also help the US company defend itself from competition from Cervarix, the GlaxoSmithKline cervical cancer vaccine which just gained US Food and Drug Administration approval last September.

'We are excited to learn more about the potential of Gardasil to help prevent HPV and HPV-related cancers and diseases in both men and women,' said Richard Haupt, executive director, Merck Research Laboratories.