To date, GlaxoSmithKline’s HPV-vaccine, Cervarix has been approved in 95 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

GlaxoSmithKline has won another European contract for the cervical cancer vaccine Cervarix. The Dutch government selected Cervarix for a new program to vaccinate all girls aged 12 with a catch-up program for girls aged 13 to 16 in the second half of 2009. In the first year some 350,000 Dutch girls will get the jab.

GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK’s Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.