Merck Submits Request to Market Gardasil to Men

Jan 07, 2009

Merck may have one of the most popular vaccines on the market in its human papilloma vaccine Gardasil, but the drug giant is banking that the product can do more than help just young women.

News broke on Monday that Merck has asked FDA to review new Phase III data demonstrating the positive effects of vaccinating men with Gardasil—data that were first presented in November at the annual meeting of EUROGIN (the European Research Organisation on Genital Infection and Neoplasia).

“We found a robust reduction in infection and disease in men,” said Anna Giuliano, a scientist at the H. Lee Moffitt Cancer Center in Tampa, and a lead investigator on the trial. “This was really exciting because it opens the door to a method of prevention that men can benefit from as well as women.”

An Equity Issue
According to Giuliano, data showed that men were not just passive carriers and transmitters of the disease, as previously thought, but actually suffer consequences from the infection.

“There is a significant cancer burden in men—men get cancer as a consequence of HPV infection—particularly in the anal cavity and penis,” Giuliano told Pharm Exec. “And in some cases, the incidence of these cancers is approaching what we see for cervical cancer in the United States.”

It turns out that a high proportion of these cancers are caused by the same strains of HPV that Gardasil is designed to prevent. The vaccine was also found to be helpful in lowering the incidence of genital warts by 90 percent.

“It’s almost an equity issue,” Giuliano said. “If you have a vaccine and it shows that it reduces infectious disease in males, shouldn’t they have access to the vaccine as women do?”

Side effects in men are the same as in women, including a small amount of pain around the injection area and a small number of people who develop a low-grade fever.

But the big question remains: If the vaccine is approved, how do you market it to men?

Giuliano agrees that it will be a challenge. “It’s hard enough to teach doctors about treating men with the vaccine,” she said. “Merck will have to start a major public service educational program about the importance of vaccination. It’s going to take some time, but I think once people understand what the issues are, they will get excited about it.”