The big papillomavirus conference in Malmö, Sweden, over the weekend has put HPV vaccines squarely in the spotlight. As we reported Friday, Glaxo touted a new Cervarix-vs.-Merck's Gardasil head-to-head study, saying Cervarix prompted a stronger immune response. Meanwhile, Merck was announcing its data: That Gardasil offers protection from certain HPV strains for up to 9.5 years; previously, the company only had data showing that Gardasil's protective shield lasted for five years. In another study, Merck's vaccine cut down on abnormal Pap tests and cervical procedures.
But the larger question on observers' minds was this: With Merck's U.S. sales of Gardasil on a precipitous slide--and GSK's shot not even on the market stateside yet--can trial data make a big difference in revenues for either company?
Let's see. Merck is in the catbird seat on this one; as the sole HPV shot available in the U.S. to date--one with a major marketing blitz behind it--it's fully entrenched in the market. Even so, the drugmaker has watched sales decline and decline, for a variety of reasons. Partly, Gardasil has been a victim of its own success, because as more and more girls and young women complete their three-shot series, the pool of unvaccinated females shrinks. To grow that market Merck has been looking for broader Gardasil use--in older women and in boys.
Meanwhile, if the FDA gives Cervarix the OK, Glaxo will be fighting uphill. And the company faces some efficacy worries back home in the U.K. The Scotsman reports that an influential German public-health organization is reviewing HPV vaccination--both Cervarix and Gardasil--after 13 researchers claimed that governments may have bought into "overly optimistic" assumptions about how effective HPV vaccination really is against cervical cancer; the Robert Koch Institute says it will issue a report in two weeks. Critics in Scotland are calling for government to review its $97 million vaccination program, too.