GSK's Cervarix receives positive opinion in Europe

Jul 19 2007

GlaxoSmithKline has announced that its cervical cancer candidate vaccine received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the prevention of precancerous lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus types 16 and 18.

This proposed indication is based on data generated in girls and women aged between 10 and 25.

The positive opinion was reached after the CHMP reviewed data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date, which demonstrated that the candidate vaccine showed an excellent efficacy profile and was generally well tolerated.

"Today's positive opinion from the CHMP is great news for women across Europe. It is a significant step towards achieving our ambition -- to provide women with protection against cervical cancer. Coupled with the excellent clinical trial results published recently, this news is further evidence of the great potential of our cervical cancer candidate vaccine," said JP Garnier, Chief Executive Officer of GSK.

The GSK cervical cancer candidate vaccine will now be proposed for final approval by the European Commission and a Marketing Authorisation could be granted in the coming months.

To date, over 40,000 women have participated or are currently taking part in clinical trials to evaluate the efficacy and immunogenicity of GSK's cervical cancer candidate vaccine. In completed clinical trials, GSK's cervical cancer candidate vaccine has been shown to be generally well- tolerated.

GSK's cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types. Duration of protection is particularly important as women may acquire infections throughout their lifetimes. Published data have shown that the vaccine formulated with this adjuvant system induces an immune response of higher magnitude and persistence compared to a GSK vaccine formulated with conventional aluminum hydroxide adjuvant alone.

Following its first license in a major market granted by the Therapeutic Goods Administration (TGA) of Australia, Cervarix(TM) is now available in Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females age 10 to 45 years.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for GSK's cervical cancer candidate vaccine in March 2007, following earlier regulatory filings in Africa, Asia and Latin America.

Several clinical studies of GSK's cervical cancer candidate vaccine are ongoing and GSK expects to file additional data with regulatory authorities as these studies are completed. In January 2007, GSK announced that it had initiated the first study of its kind designed to compare the immunogenicity of its cervical cancer candidate vaccine, versus Gardasil(TM). The primary objective of the head-to-head trial is to compare the immune responses to cancer-causing virus types 16 and 18 in U.S. women 18 to 26-years-old. Secondary objectives include evaluating the immune responses to virus types 16 and 18 in women 27 to 35-years-old and 36 to 45-years-old. In addition, the study will compare immune responses to other cancer-causing virus types. Results are expected 12 months after patient enrollment is complete, with extended follow up continuing for approximately 17 months after the last study visit (month 7 through to month 24).

Cervical cancer is the second leading cause of cancer in women under 45, and causes over 270,000 deaths worldwide per year.(iii) It occurs when infection with the human papillomavirus becomes persistent, and progresses to cancer. Up to 80 per cent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.(iv, v, vi) Approximately 100 types of human papillomavirus have been identified to date and, of these, approximately 15 virus types are considered to cause cervical cancer.(vii, viii) Virus types 16 and 18 are responsible for approximately 71.5 per cent of cervical cancers in Europe.(ix)