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Cervical-Cancer Vaccines' Makers Argue Over Study

Posted on: Thursday, 6 April 2006, 09:01 CDT

By Thomas Ginsberg, The Philadelphia Inquirer

Apr. 6--Battling over the potentially huge market in cervical-cancer vaccines, GlaxoSmithKline P.L.C. and Merck & Co. Inc. sparred yesterday over a study showing that one product blocks more infections than first thought.

GlaxoSmithKline's Cervarix and Merck's Gardasil have been shown to prevent the two human papillomaviruses (HPV) known to cause about 70 percent of cervical cancers. Neither vaccine has been approved for use.

Researchers say about 30 of 100 types of human papillomavirus can cause cervical cancer, with most caused by HPV types 16 and 11. Each company is trying to differentiate its product for the expected lucrative business of vaccinating tens of millions of people -- mostly girls -- worldwide.

London-based GlaxoSmithKline, whose U.S. headquarters is partially based in Philadelphia, said results of a clinical trial being published today in the British journal The Lancet showed that Cervarix also prevented infection by HPV types 45 and 31, which are blamed for an additional 10 percent of cancers.

GlaxoSmithKline, calling the findings "unexpected," said studies were continuing on whether Cervarix actually prevented the precancerous lesions in those cases. But it potentially makes Cervarix a "broader" vaccine against 80 percent of cancer cases, said GlaxoSmithKline's Philadelphia-based vice president for HPV vaccine clinical development, Gary Dubin, a coauthor of the study.

Merck, which is based in Whitehouse Station, N.J., and which has its vaccine division in West Point, Montgomery County, immediately questioned GlaxoSmithKline's study. One of its HPV researchers, Eliav Barr, called Dubin's analysis "unorthodox" and emphasized that Merck also was testing for additional virus protections. Merck's vaccine already has been shown to help prevent HPV infections that cause genital warts.

Reacting to Merck's criticism, Dubin defended the study results as highly reliable and suggested that a reporter "ignore" Merck's comment.

Merck, which expects to manufacture its vaccine in West Point, is leading the race to market. The U.S. Food and Drug Administration is scheduled to decide on Gardasil by June 8, Merck said. Cervarix is under consideration in Europe but will not be submitted to the FDA until later this year, GlaxoSmithKline said.

Both approvals are being sought for girls 13 and older. FDA approval is required before health officials can decide whether to recommend or mandate vaccinations. Merck and GlaxoSmithKline say their marketing will emphasize sexual abstinence and Pap smears, in addition to vaccination.

Cervical cancer strikes nearly 500,000 women a year worldwide, killing an estimated 270,000, mostly in the developing world, where Pap smears are less common.

Contact staff writer Thomas Ginsberg at 215-854-4177 or tginsberg@phillynews.com.

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Copyright (c) 2006, The Philadelphia Inquirer

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Source: The Philadelphia Inquirer

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