GSK LAUNCHES STUDY TO CHALLENGE MERCK'S GARDASIL

British drugmaker GlaxoSmithKline (GSK) has begun a study designed to compare the immunogenicity of its experimental cervical cancer vaccine, Cervarix, with Merck's Gardasil. The goal of the head-to-head trial is to compare the immune responses to human papillomavirus (HPV) types 16 and 18 in women 18 to 26 years old. In addition, the study will compare immune responses to other cancer-causing HPV types. GSK expects initial results within a year after study enrollment is completed.

Data published in Vaccine in August 2006 demonstrated GSK's cervical candidate vaccine, formulated with the proprietary adjuvant system AS04, induced higher antibody levels and more robust immune memory response compared to the same HPV vaccine composition conventionally formulated with aluminium hydroxide adjuvant alone, according to the company. Furthermore, data published in The Lancet in April 2006 provided evidence that GSK's cervical cancer candidate vaccine demonstrated protection for up to 4.5 years against persistent infection with HPV 16 and 18 — the two most common cancer-causing HPV types — and protection from precancerous lesions.

GSK submitted a marketing application for Cervarix to the European Medicines Agency in March 2006. Applications have also been submitted in Australia, parts of Asia and parts of Latin America. The company plans to file a biologics license application for Cervarix with the U.S. FDA by April.