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Merck's Experimental Vaccine Prevents Cancer Caused by Virus; Seeking FDA Approval This Year
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Oct. 6 (Bloomberg) -- Merck & Co. said its experimental vaccine to protect against a virus that causes genital warts and cervical cancer prevented two common forms of the disease in a study of women.
The vaccine, to be sold as Gardasil, prevented cells on the cervix from becoming pre-cancerous and also blocked the development of a cancer that occurs on the surface of a cervix, Whitehouse Station, New Jersey-based Merck said in a statement today. Merck has said it plans to seek approval by the end of the year to market Gardasil, which would be only the second vaccine available to prevent a cancer.
About 20 million men and women in the U.S. are infected with the human papillomavirus, or HPV, and about 5.5 million new cases occur each year, according to the American Social Health Association. While many of the sexually-transmitted infections resolve naturally, others develop into genital warts and cervical cancer. No prevention for the virus currently exists.
``It's really an important finding because cervical cancer and high-grade pre-cancers are really such public health problems,'' said Eliav Barr, a senior director of clinical research at Merck in a telephone interview.
None of the women who took Gardasil in the study developed pre-cancerous cells or cancer. That compares with 21 women on a placebo who developed pre-cancerous changes in their cervix cells, Barr said. About 12,000 women between the ages of 16 and 26 were followed in the study for about two years. Its results are being presented tomorrow at the Infectious Diseases Society of America meeting in San Francisco
More than 10,000 women in the U.S. develop cervical cancer each year and 3,900 die from it, according to the American Cancer Society. Between 500,000 and 1 million new cases of genital warts occur each year in the U.S., Merck said.
Sexually Active People
Currently, sexually active people have no way to protect themselves from HPV if their partner is infected, and the vast majority of infections go undetected. No pills are approved to treat the disease. Surgery can remove precancerous lesions if detected early and medicine can treat genital warts.
In May, Merck said Gardasil produced a stronger immune response in girls and boys ages 10 to 15 than it did in young women, suggesting the vaccine ought to be used in children. The early adolescents were more likely to develop antibodies to fight the sexually transmitted disease and at greater levels.
Merck is racing against GlaxoSmithKline Plc to bring the first HPV vaccine to the U.S. market. Merck is counting on the Gardasil to help replace revenue lost from its top products, the withdrawn Vioxx painkiller and Zocor, a cholesterol drug losing patent protection next year.
Vaccines against the virus hepatitis B can prevent liver cancer caused by the viral infection.
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