EUROPEAN COMMISSION APPROVES MERCK'S CERVICAL CANCER VACCINE

Merck has announced that the European Commission has approved its cervical cancer vaccine, Gardasil (quadrivalent human papillomavirus recombinant vaccine). Gardasil has been approved as the first and only vaccine in the European Union (EU) for use in children and adolescents ages 9 to 15 and adult females ages 16 to 26 for the prevention of cervical cancer, high-grade cervical dysplasias/precancers, high-grade/precancerous vulvar dysplastic lesions and external genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

The vaccine will be marketed by Sanofi Pasteur MSD, a joint venture between Sanofi Pasteur and Merck, in 19 European countries including 15 in the EU. In the remaining countries, the vaccine will be marketed by Merck Sharp & Dohme as either Gardasil or Silgard.

The FDA approved Gardasil on June 8 for girls and women over the age of 9. Gardasil is also approved in Mexico, Australia, Canada, New Zealand, Brazil and some African countries. Additionally, Merck is working to accelerate the availability of Gardasil in the developing world and is working with the Gates Foundation to develop HPV vaccination programs. The company will make the new vaccine available for lower prices in developing countries.