February 13, 2007
Merck ‘encouraged’ Gardasil can offer wider cervical cancer protection
A Merck executive said the company is “encouraged” that its Gardasil vaccine can offer wider protection against cervical cancer than levels claimed on the product’s labeling. Gardasil was approved in June to protect against strains 16 and 18 of the human papillomavirus (HPV), which account for 70% of cervical cancer cases, and HPV strains 6 and 11, which account for 90% of genital warts cases. There are more than 100 strains of HPV. Merck said it is studying whether Gardasil can actually prevent precancerous lesions caused by some additional HPV strains. “We’re encouraged by the interim analysis of the endpoints,” said Bev Lybrand, a Merck VP who heads up the Gardasil commercialization effort. Lybrand made the remarks during a Merrill Lynch conference broadcast over the Internet and published in a Dow Jones Newswire report. Merck hopes to present clinical outcome data on cross-protection “as soon as possible at an appropriate medical meeting,” Lybrand said. A claim of cross-protection could also help Gardasil better compete with rival vaccine Cervarix by GlaxoSmithKline. GSK has filed for European regulatory approval for Cervarix and expects to apply for FDA approval in April. Cervarix targets the same two cancer-causing HPV strains as Gardasil but not the strains associated with genital warts. GSK execs have also said Cervarix could offer cross-protection against additional, cancer-causing HPV strains, according to a published report.