Healthy Skepticism Library item: 8291
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Loftus P.
Merck: Gardasil May Fight More Strains
Associated Press 2007 Feb 6
http://biz.yahoo.com/ap/070206/merck_gardasil_vaccine.html?.v=1
Full text:
Merck Sees Signs Gardasil Can Give Broader Protection V. Cervical Cancer Than Label Suggests
PHILADELPHIA (AP) — Merck & Co. has seen “encouraging” signs that its Gardasil vaccine can offer broader protection against cervical cancer than the level currently claimed on the product’s label, an executive said Tuesday.
Merck, of Whitehouse Station, N.J., began selling Gardasil in June after the Food and Drug Administration approved it to prevent infection by four strains of the human papillomavirus, or HPV, a sexually transmitted virus. Two of the HPV strains targeted by Gardasil are responsible for causing about 70 percent of all cases of cervical cancer in women; the other two strains primarily cause genital warts.
The drug company has suggested that Gardasil could offer so-called “cross-protection” against additional, cancer-causing strains of HPV that aren’t directly targeted by the vaccine. If this is true, Gardasil could potentially protect against HPV strains responsible for more than 70 percent of cervical-cancer cases.
Merck is now studying whether Gardasil can actually prevent precancerous lesions that are caused by the additional HPV strains, and early data from the study have been encouraging, the company said.
“We’re encouraged by the interim analysis of the endpoints,” Bev Lybrand, a Merck vice president who heads the Gardasil commercialization effort, told a Merrill Lynch conference in New York Tuesday in remarks broadcast over the Internet.
Merck hopes to present the clinical-outcome data on cross-protection “as soon as possible at an appropriate medical meeting,” Lybrand said.
Besides its public-health importance, a claim of cross-protection for Gardasil might help it better compete with a potential rival vaccine from London-based GlaxoSmithKline PLC.
Glaxo has applied for European regulatory approval of its Cervarix cervical-cancer vaccine, and expects to apply for U.S. approval in April. Cervarix targets the same two cancer-causing HPV strains as Gardasil, but not the two strains associated with genital warts. But Glaxo executives also have said Cervarix could offer cross-protection against additional, cancer-causing HPV strains.
On the New York Stock Exchange Tuesday Merck shares closed up 6 cents at $44.64. Glaxo American depositary shares closed up 42 cents at $55.56.
