Pfizer/Neurocrine indiplon resubmission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck's human papillomavirus vaccine Gardasil shows a higher efficacy rate in adolescents (male and female) aged 10 to 15 than in young women aged 16 to 23, according to a Phase III study presented May 19 at the European Society of Pediatric Infectious Diseases. In the 1,529-patient trial, seroconversion rates in the combined adolescent cohort (506 female, 510 male) were 100% for HPV types 16, 6 and 11, and 99.9% for HPV 18. Results were identical in the 513 16-23-year old women, except for serotype 18, for which Gardasil produced a 99.1% conversion rate. The study comes on the heels of a Phase II trial published in the April issue of Lancet Oncology, in which the quadrivalent vaccine was shown to significantly reduce the combined incidence of persistent HPV 16, 18, 6 or 11 compared to placebo. Merck plans to file a Gardasil BLA in the second half of 2005 (1Pharmaceutical Approvals Monthly May 2005, In Brief)...
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Merck Gardasil Phase II data
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...
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