Merck Cancer Shot Cuts Genital Warts, Lesions in Men
Bloomberg November 13, 2008

Merck & Co.'s Gardasil shot, used to prevent cervical cancer in women, slashed the risk of genital warts and pre-cancerous lesions by 90 percent in men, according to the largest study of the vaccine in males.

Merck said it will use the data to seek U.S. approval to sell Gardasil for males this year to protect against warts and the lesions, which may lead to cancer of the penis and anus. The shot protects against the sexually transmitted human papillomavirus, or HPV.

Gardasil, approved for females ages 9 to 26, is given mostly to school-age girls as a U.S.-recommended routine vaccination. The vaccine is designed to prevent HPV infection, which causes cervical cancer and genital warts, and has been linked to cancers of the penis and anus in men. Expanding the vaccine to males could revive sales, which declined 4 percent in the third quarter, analysts said.

``We finally have something we may be able to offer men as well as women,'' said Anna Giuliano, 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, Florida. ``It really opens the door to preventing infection and hopefully cancer and genital warts in males.''

The research, funded by Whitehouse Station, New Jersey-based Merck, is being presented today at the European Research Organization on Genital Infection and Neoplasia in Nice, France. Merck rose $1.81, or 6.8 percent, to $28.53 at 4:04 p.m. in New York Stock Exchange composite trading.

Study Findings

Researchers gave 4,065 males ages 16 to 26 three shots of the vaccine or a placebo, then tracked them for signs of infection with HPV. After about 30 months, three men getting Gardasil developed genital warts and none had pre-cancerous growths linked to the HPV virus, compared with 28 cases of warts and three pre-cancerous lesions in the placebo group.

HPV may cause about 1,500 men to develop penile cancer a year and 1,900 to get anal cancer, according to the Centers for Disease Control and Prevention. Men who have sex with men are 17 times more likely to develop anal cancer from HPV, the CDC said.

None of the men were infected with HPV before the start of the study. The vast majority of those in the trial, 3,400 volunteers, were heterosexual males. Men are viewed as the key transmitters of HPV to women. Another 600 were homosexual men, who have an elevated risk of developing some cancers.

The shot also reduced the likelihood that the men would develop persistent HPV infection, when the virus is detected in two or more consecutive doctor visits.

Expanded Use

Expanded use of Gardasil to men and boys can help revive sales, which fell 4 percent to $401 million in the third quarter. About 2.5 million girls ages 13 to 17 were vaccinated with Gardasil last year, according to CDC. The company has been less successful in persuading young women to get the shot, which has limited sales of the product.

If approved for males, more than 350,000 boys and young men, ages 11 to 26, could get the $400 vaccine next year, increasing to more than 1 million annually by 2011, Merrill Lynch analyst David Risinger estimated in a Sept. 4 research report. He expects the vaccine could reach $2.7 billion in peak sales in 2011.

The shot protects against infection caused by HPV types 6, 11, 16 and 18 -- four of the 40 types of the virus found in the genital area. More than 1 million cases of genital lesions, which can lead to cancer, occur in men and women in the U.S. each year, and 30 million cases occur worldwide, Merck said in a statement.

While 20 million Americans are infected with HPV, most will be able to fight off the infection naturally. About 1 percent of sexually active men in the U.S. will develop genital warts from HPV, the CDC said. Gardasil is already approved for males in 40 countries worldwide.

Awaiting Data

It's unlikely that U.S. doctors will start to give the shot to boys at this stage, since the Food and Drug Administration hasn't reviewed the findings and more data is coming, Giuliano said.

``The first really important step is to have Merck do a filing with the FDA, and have the FDA make a decision,'' she said. ``Although I think you get sporadic use of vaccines off label, I don't think it would ever be common practice.''

The CDC's vaccine committee will meet next year to consider whether the shot should be recommended for boys, Giuliano said.

Merck also is awaiting an FDA decision about whether the company can market the vaccine for women through age 45.