FDA approves Merck's cervical cancer vaccine

Merck & Co. won US approval yesterday to sell the first vaccine designed to prevent a cancer, targeting the number two malignancy of women worldwide.

The vaccine, called Gardasil, is intended to thwart cervical cancer by blocking infection from human papillomavirus, which is spread through sexual contact. The Food and Drug Administration yesterday permitted Gardasil for females ages 9 through 26, with the goal of inoculating girls before they may become sexually active.

About half a million women are diagnosed with cervical cancer each year. The approval raises the possibility that a cancer may be eliminated within a generation, specialists said. It is also a victory for Merck, the fourth-biggest US drug maker, which has focused increasingly on vaccines and may generate $3 billion in annual sales from Gardasil alone.

``It's important from a public health perspective because you're eliminating a cancer," said Les Funtleyder, an analyst in New York for Miller Tabak & Co. ``The subtle point is these guys are creating new drugs for important health problems, which is what pharma is supposed to do."

Shares of Merck, based in Whitehouse Station, N.J., rose 1 cent to $33.97 in New York Stock Exchange composite trading.

Gardasil shots will be given in three doses over six months, with each dose costing $120, Merck said. Affordability may help determine how effective the drug is in quelling cervical cancer, since 80 percent of the cases are in poorer countries.

``Critical to success will be ensuring that women in the world's poorest countries -- where cervical cancer hits hardest -- have rapid and affordable access to this lifesaving new tool," said Gabriel N. Hortobagyi, a physician at the University of Texas M.D. Anderson Cancer Center in Houston, and president of the American Society of Clinical Oncology, in a statement yesterday. Human papillomavirus, or HPV, is one of the most common sexually transmitted viruses in the world, and causes genital warts as well as cancer. About 20 million people in the United States are infected, according to the US Centers for Disease Control and Prevention.

In the United States, where Pap smear screening is widespread, about 14,000 women are diagnosed with cervical cancer each year and 3,900 die from it. Only breast cancer strikes more women globally than cervical cancer.

Merck's vaccine targets four strains of HPV, two of which are responsible for 70 percent of cervical cancer cases.

Research presented last week at the oncology society's annual meeting showed the vaccine also helped prevent cancers of the vagina and vulva, which are diagnosed in about 6,000 US women every year and cause about 1,700 deaths, the society said.

``This represents a triumph of basic science and of molecular biology research," John Niederhuber, acting director of the National Cancer Institute, said at a news conference in Washington.

Research is under way, he said, to allow the vaccine to be administered orally and to prevent it from having to be refrigerated, both of which would broaden its availability.

Scientists also are trying to determine how many years the vaccine will be effective. Tests so far have shown the shots to work for three-and-a-half years, said Jesse Goodman, an FDA official.

Merck has waged a consumer awareness campaign for almost a year designed to help seed the market for the vaccine. As recently as 18 months ago, Merck's research showed that fewer than 20 percent of American women knew that HPV causes cervical cancer, the company said.

The campaign is also designed to help ease concerns among parents worried about adding another routine childhood vaccine. Gardasil is the third vaccine Merck is introducing this year. Last month, the company won US approval of its Zostavax shingles vaccine and in February gained clearance for a shot against rotavirus, the most common cause of severe diarrhea in children. The company is expanding its vaccines business to build sales and profit after its top-selling drug, the cholesterol treatment Zocor, loses patent protection this month.