Philadelphia Inquirer Examines HPV Vaccine Development, Marketing Competition Between Merck, GSK

The Philadelphia Inquirer on Sunday examined the competition between Merck and GlaxoSmithKline on the development and marketing of human papillomavirus vaccines (Stark, Philadelphia Inquirer, 7/8).

Merck's HPV vaccine Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women's Health Policy Report, 6/26).

Cervarix also has shown to be 100% effective in preventing infection with HPV strains 16 and 18. According to preliminary data from a Phase III clinical trial, published last month in the journal Lancet, Cervarix also provided significant protection against HPV strains 31, 45 and 52, which together account for about 12% of cervical cancer cases. The Australian Therapeutic Goods Administration last month granted the first major market license for Cervarix, approving the vaccine for girls and women ages 10 to 45. The European Medicines Agency could recommend the vaccine this month. FDA has granted a standard 10-month review of Cervarix and will most likely take action on GSK's application in January 2008, according to analysts at Evolution Securities (Kaiser Daily Women's Health Policy Report, 6/28).














Gardasil might have a "potential advantage" over Cervarix because it protects against strains 6 and 11, the Inquirer reports. GSK officials say that the narrower focus of Cervarix makes it better in preventing cervical cancer.

According to the Inquirer, some experts have said that they have not found an advantage for Cervarix and that Gardasil's genital wart coverage might give it a temporary edge. Hildegund Ertl, founding director of the Wistar Institute Vaccine Center, said if given a choice, she would choose Gardasil "because of the extra protection." John Schiller, a senior investigator at the National Cancer Institute, said, "There's going to be a bit of an arms race between Merck and GSK," adding, "I wouldn't be surprised if GSK adds the wart types."

According to the Inquirer, Gardasil is expected to reach at least $1 billion in sales after one year on the U.S. market. In an attempt to "leapfrog its competition," GSK is funding a clinical trial to determine whether Cervarix is more effective than Gardasil, with results expected early next year, the Inquirer reports. Merck is developing another HPV vaccine, currently being tested in Phase II clinical trials, that aims to block eight HPV types.

Enrique Hernandez, chair of obstetrics and gynecology at Temple University Hospital who has served on advisory boards at both GSK and Merck, said the choice will come down to the price. "Whoever comes out with a cheaper product wins," he said, adding that he does not "think there's a significant difference" between the two vaccines (Philadelphia Inquirer, 7/8).

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View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil.