Cervarix® U.S. regulatory update

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

Philadelphia US & London UK.- GlaxoSmithKline today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX®, its vaccine to prevent cervical cancer and cervical pre-cancer related to human papillomavirus types 16 and 18.

GSK has submitted final data from its Phase III pivotal efficacy study, HPV-008, to the FDA. The FDA has previously reviewed interim data from the same trial. FDA review of this type of Biologics License Application (BLA) submission is expected to take six months, according to agency regulations.

"We are pleased to have reached this significant milestone for CERVARIX®. The data submitted to the FDA reaffirm our confidence in the vaccine’s safety and efficacy profile,” said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. “We will continue working closely with the FDA in order to make this vaccine available to help protect the cervical health of girls and women in the U.S.”

HPV-008 is a Phase III clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and Latin and North America. The primary objective was to assess vaccine efficacy in the prevention of high-grade pre-cancerous cervical lesions (CIN2+) caused by human papillomavirus types 16 or 18. Secondary objectives included evaluation of vaccine efficacy in the prevention of pre-cancerous cervical lesions (CIN1+) and infections caused by virus types 16 or 18 or other cancer-causing virus types, as well as immune response and safety. GSK will submit the data to a peer-reviewed journal in the coming months.

The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population.

To date, GSK’s vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 20 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.