Sanofi-Pasteur MSD's hopes of launching the cervical cancer vaccine Gardasil onto the European market were raised on Friday when the continent's scientific advisory panel gave it the thumbs up. Full approval is anticipated within a two-month timeframe, just nine months after filing, opening the door to another enormous region for the potential multi-billion dollar offering.
Specifically, the Committee for Medicinal Products for Human Use (CHMP) has given Gardasil the go-ahead for protecting girls aged nine-15 and women aged 16-26 from the four strains of the human papillomavirus responsible for some 70% of cervical cancer cases, as well as genital warts, and cervical, vaginal and vulval lesions.
In Europe, cervical cancer is the second most common cause of death after cancer of the breast in young women, with 15,000 deaths annually.
Gardasil was first approved in Mexico on June 1, followed swiftly by nods in the USA, Australia, Canada and New Zealand. And, importantly in the world's largest pharmaceutical market, the US Centers for Disease Control and Prevention followed this up with a nod for routine immunization of 11-12 year olds and catch-up immunization of 13-26 year olds who have not previously be vaccinated.
Analysts have forecast sales of around $3 billion for Gardasil, which should put a smile on developer Merck's face. The company is expected to rake in more than upcoming rival GlaxoSmithKline's Cervarix, which will be later to the US market, with a filing anticipated towards the end of the year. It sought European approval in March.