Merck Gardasil Phase II data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck's therapeutic human papilloma virus vaccine Gardasil showed significant protection against infection and pre-cancerous lesions in a Phase II trial, the company says April 6. Two and a half years post-vaccination, the combined incidence of persistent infection from HPV six, 11, 16 or 18 and related genital disease was reduced by 90% compared to placebo (p<0.001). The 552-patient study included women between 16 and 23 years of age, with a primary endpoint of efficacy at day one, month two and month six. Results were published in the April 2005 Lancet Oncology. Merck plans to file a Gardasil BLA in the second half of 2005. GlaxoSmithKline has a royalty stake in Gardasil under a cross-licensing deal announced in February (1Pharmaceutical Approvals Monthly February 2005, p. 18). GSK has not announced a filing timeframe for its own HPV vaccine, Cervarix...