Merck Cancer Shot Cuts Genital Warts, Lesions in Men (Update2)
Nov. 13 (Bloomberg) –
'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
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
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.
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
. 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.
, 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
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.
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.
Last Updated: November 13, 2008 16:10 EST