Placebo groups to be switched to Gardasil

European vaccine specialist Sanofi Pasteur MSD says that the independent Data and Safety Monitoring Board of two large-scale trials, FUTURE I and II, has recommended that its cervical cancer vaccine Gardasil (quadrivalent human papilloma virus [types 6, 11, 16, 18] recombinant vaccine) should be given to women in the placebo group.

In Europe, vaccination of these cohorts of the FUTURE I and II studies has already begun, in study centers in Germany, Sweden, Denmark and Austria. In other countries, vaccination will start within the next days or weeks. In total, approximately 4,300 women are anticipated to be vaccinated in European study sites, with the objective of completing before the end of the year 2007. In a similar way, vaccination of almost 4,500 women in many other countries around the world, including the USA, Australia and Canada, has begun or is anticipated to start soon.

Gardasil licence applications have been filed in 120 countries with approvals in 55 so far, all under accelerated review timelines, including the European Union, the USA, Canada and Australia. In fourth-quarter 2006, Gardasil earned its US originator Merck & Co $155.0 million after it was approved in June (Marketletter February 5).