MERCK'S HPV VACCINE RECEIVES POSITIVE OPINION FROM CHMP
Sanofi Pasteur MSD, the joint venture of Sanofi Pasteur and Merck, announced that Gardasil (quadrivalent human papillomavirus recombinant vaccine), has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion recommends that the vaccine be approved for the immunization of children and adolescents ages 9 to 15 and adult females ages 16 to 26 for the prevention of cervical cancer and external genital warts caused by human papillomavirus (HPV) Types 6, 11, 16 and 18.
Following CHMP review, the opinion will transmitted to the European Commission. If the commission approves the opinion, it will then decide on approval. This decision will be applicable to the 25 countries that are members of the European Union (EU).
Gardasil will be marketed by Sanofi Pasteur in EU countries covered by the
joint venture and several other European countries. In the countries located
in central and eastern Europe, it will be marketed by Merck Sharp & Dohme
as either Gardasil or Silgard.