Gardasil for males? Report hikes hopes

Will yesterday's news that Merck's Gardasil vaccine may protect men, as well as women, from a deadly virus bolster sales of a product that so far has failed to fulfill its maker's hopes for a blockbuster?

In the United States, Gardasil is marketed only to women to prevent human papillomavirus, or HPV, infection, which can cause cervical cancer. But Merck & Co. Inc. released results showing that the vaccine was also effective against HPV in men, where the virus can cause genital warts and some kinds of cancer.

Extending the vaccine's use to males would effectively double the market.

When Gardasil was introduced in the United States in 2006, Merck and its investors anticipated a vaccine that could become mandatory for girls and young women.

But attempts at mandating the vaccine failed and fueled controversies about whether it was crucial to women's health. Some experts also raised concerns that getting the vaccine would lead women to think they no longer needed Pap smears to detect cervical cancer. Pap smears are still necessary because Gardasil protects against only 70 percent of cancer-causing HPV strains.

Merck is based in Whitehouse Station, N.J., but makes Gardasil and other vaccines at its West Point facilities, outside Philadelphia.

The vaccine has not met expectations for many reasons, including controversies over its use and the challenges of persuading women to get a series of shots.

The Food and Drug Administration has approved Gardasil for use in girls and women ages 9 to 26, but women at the older end of that group are less likely to get the vaccine because they may believe they already have been exposed to HPV and because they no longer see pediatricians, who administer vaccines more often than general practitioners or gynecologists.

"Merck was hoping 17- to 24-year-olds would come in for this, but we just haven't seen the uptake," said Les Funtleyder, an analyst with Miller Tabak & Co. and author of the forthcoming book Healthcare Investing.

Those problems caused Merck in the second quarter of this year to cut 2008 sales forecasts for Gardasil to $1.4 billion to $1.5 billion, a $500 million decrease. The company this year has implemented programs, such as reimbursing doctors who give the vaccine to uninsured patients, to promote Gardasil's use.

Yesterday, Merck reported early results of a Phase III study of 4,000 males ages 16 to 26 showing that Gardasil lowered the risk of genital warts and precancerous lesions by 90 percent. There were three cases of genital lesions in the Gardasil group and 31 in the group receiving placebos. Merck plans to file an application this year asking the FDA to approve Gardasil for boys and men aged 9 to 26 to prevent genital warts.

If approved for males, more than 350,000 boys and young men, ages 11 to 26, could get the vaccine next year, increasing to more than a million annually by 2011, Merrill Lynch & Co. Inc. analyst David Risinger estimated in a Sept. 4 research report. He said the vaccine could reach $2.7 billion in sales in 2011.

Merck would not discuss any potential sales impact from the results released yesterday because Gardasil is not approved for use in boys and men in the United States. It is approved for use in boys in 40 other countries.

Anna Giuliano, a lead researcher on the study, said the results could provide evidence for vaccinating men against HPV, both to prevent the spread to their partners and to protect them against penile, anal and other types of cancer linked to HPV.

"This is really, really exciting, promising news in terms of what the future means for preventing these types of cancers in men," said Giuliano, a professor of medicine and epidemiology at the University of South Florida and a program leader in risk assessment at the H. Lee Moffitt Cancer Center in Tampa, Fla.

Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins University, agreed that the results were positive and said that he believed the FDA would approve Gardasil for use in males. But he said Gardasil's cost, $360 for a series of three shots, could make medical policymakers reluctant to recommend its use in boys and men. The Centers for Disease Control and Prevention recommends Gardasil for 11- and 12-year-old girls and will decide whether to recommend it for boys and men if the FDA approves it.

"The difficult thing is going to be for the advisory groups to decide whether a vaccine should be recommended, and who should pay," Halsey said.

Merck shares closed yesterday at $28.53, up 6.8 percent, on the New York Stock Exchange.