June 9, 2006

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Merck Cervical-Cancer Vaccine
Cleared for Use in Girls, Women

WASHINGTON -- The Food and Drug Administration approved the first vaccine designed to protect women against cervical cancer. The vaccine, Gardasil, was approved for use in girls and women ages 9 to 26.

Gardasil, by Merck & Co., protects against four strains of the human papillomavirus, or HPV, two of which account for about 70% of cervical-cancer cases.

Because the vaccine doesn't protect against all of the viruses linked to cervical cancer, it won't eliminate the need for women to undergo routine pap tests that look for precancerous lesions and cervical cancer.

Still, the approval of the vaccine has the potential to sharply cut the nearly half million cases of cervical cancer seen world-wide annually. It is the second approved vaccine designed to protect against a type of cancer -- the Hepatitis B vaccine protects against some cases of liver cancer.

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Margaret McGlynn,¹ president of Merck's vaccines business, comments on the FDA approving Gardasil, her company's cervical cancer vaccine.

Gardasil's approval marks the third major vaccine approval this year for Merck. Last month, the FDA approved a vaccine designed to protect against shingles in older Americans and in February, approved a vaccine to protect infants from rotavirus.

There are more than 100 strains of HPV. The virus is spread mainly through sexual contact and is the most common sexually transmitted disease in the U.S. In most cases, however, HPV infection clears up on its own without causing cancer and other health problems.

Gardasil is designed to protect against HPV strains 16 and 18, which account for most cervical-cancer cases, and strains 6 and 11, which account for 90% of genital-warts cases. Studies of the vaccine also showed it offered protection against cases of vaginal and vulvar cancer linked to HPV infection.

Merck, of Whitehouse Station, N.J., had asked the FDA for a gender-neutral approval so that the vaccine could be used in both males and females. The FDA, however, said it needs additional information on the vaccine's effectiveness before it can approve the vaccine for use in males.

Merck studied the vaccine in more than 20,000 girls and women up to age 26, and the data showed the vaccine prevented precancerous lesions and cervical cancer in patients. Merck also studied the vaccine in boys ages 9 to 15. That data, however, included only tests of Gardasil's ability to induce immune responses in boys, but not data on its effect in preventing disease. Such studies are continuing. HPV can cause genital warts and head and neck cancer in men, and since men can transmit HPV to women, preventing infection in boys could also help reduce the rate of infection in women.

Merck's vaccine next goes before a federal panel that advises the Centers for Disease Control and Prevention. That panel, set to meet this month, is expected to make recommendations about who should receive the vaccine and when. Although the CDC panel is likely to be heavily influenced by the FDA's approval recommendation, the panel could decide to recommend that boys also receive the vaccine. CDC recommendations for particular vaccines typically trigger insurance coverage.

Each state will then decide whether to add Gardasil to the list of required vaccines students need to attend public schools. Some conservative groups say the decision to vaccinate young women should be left up to parents.

In the U.S. it is likely the vaccine would be given to 11- or 12-year-old girls along with other routine vaccinations. Ideally, people would be vaccinated before they become sexually active and exposed to HPV because it can take years for cancers and genital warts to develop.

Merck said it will price Gardasil at $120 per dose. The vaccine would be given in three doses over about a six-month period.

GlaxoSmithKline PLC is working on a similar cervical-cancer vaccine, Cervarix, which it plans to submit for FDA approval by year's end.

About 9,710 new cases of invasive cervical cancer are expected to be diagnosed in the U.S. this year, and about 3,700 women are expected to die from the disease, according to the American Cancer Society.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com²