FDA Committee backs Merck & Co's Gardasil for males and GlaxoSmithKline Cervarix

In moves that were widely expected following earlier reviews by US Food and Drug Administration experts (The Pharma Letter September 7), the agency's advisory committee came out in favor of approving the use of drug major Merck & Co's Gardasil vaccine in boys and men aged nine through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. The panel also backed UK pharmaceutical giant GlaxoSmithKline's competitive agent, Cervarix, the firm's cervical cancer vaccine, making it likely that the product will finally make it to the US market. GSK has been trying for US approval of Cervarix, which is cleared in nearly 100 countries around the world, since 2007.

American depositary receipts of GSK rose a modest 0.5% to $39.22 at 4:04 p.m. in New York trading, before the meeting ended, while Merck gained 1.9 percent, to $31.55. Although GSK is expected to have a tough fight for market share in the USA, where Gardasil is already well established for the prevention of cervical cancer, Leerink Swan analyst Seamus Fernandez estimates Cervarix eventually will comprise 25%-30% of the US market for HPV-blocking vaccines

Specifically, Vaccines and Related Biological Products Advisory Committee, a panel of outside medical experts, voted that Cervarix was safe and effective at preventing an infection that can cause cervical cancer in women as well as a precancerous condition that can lead to cervical cancer FDA usually follows its panels' advice but is not required to do so. The agency could make a decision by September 29.

Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16 and 18]) vaccine, has been approved for use in the USA since June 2006 and is currently indicated for use in girls and young women aged nine through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. More than 50 million doses have been distributed worldwide through June 2009, although the number of doses administered is not known. The drug generated sales of $1.4 billion last year, compared with Cervax' turnover of just $232 million.