U.K. Regulatory Agency Concludes GSK Release Concerning Experimental HPV Vaccine Cervarix Not Misleading, Promotional

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Sep 2007 - 4:00 PDT

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The Medicines and Healthcare Products Regulatory Agency, the United Kingdom's drug regulator, on Tuesday ruled that a GlaxoSmithKline press release about its experimental human papillomavirus vaccine Cervarix was not promotional or misleading, as had been alleged by Sanofi Pasteur, Dow Jones/CNNMoney.com reports. Sanofi Pasteur -- a joint company of Merck and Sanofi-Aventis -- markets Merck's FDA approved HPV vaccine Gardasil in Europe (Loftus, Dow Jones/CNNMoney.com, 9/11).

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. Cervarix, which has been approved in Australia and is under review by FDA, 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 in a June issue of 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 (Kaiser Daily Women's Health Policy Report, 7/11).

GSK in a press release announcing the data published in the Lancet said the study found that Cervarix provided up to 100% protection against precancerous lesions cased by the most common types of HPV, Dow Jones/CNNMoney.com reports. Sanofi Pasteur complained to MHRA that GSK's release was misleading and promoted Cervarix by selectively using data from the study. MHRA on Tuesday said that it did not consider GSK's press release to be promotional, so it did not uphold Sanofi Pasteur's complaint. GSK is "pleased" with the decision and will "remain committed to an ethical approach to marketing," GSK spokesperson Alice Hunt said. A Sanofi Pasteur spokesperson could not immediately be reached, Dow Jones/CNNMoney.com reports (Dow Jones/CNNMoney.com, 9/11).

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