Panel OKs Merck Vaccine

Medical advisers to the Food and Drug Administration unanimously said Thursday that the agency should approve a Merck(MRK) vaccine against a virus that causes cervical cancer.

The FDA advisory committee said the vaccine Gardasil was safe and effective for girls and women between the ages of 9 and 26. The agency isn't bound by its advisers' recommendations, but it usually follows their suggestions. The FDA is scheduled to act on Merck's application by June 8.

If approved, Gardasil would be the first vaccine against human papillomavirus, or HPV. Although there are many types of HPV, Gardasil targets two versions of sexually transmitted HPV that account for a majority of cervical cancer cases. Merck says these two types cause an estimated 70% of cervical cancer cases. That estimate is backed by the National Cancer Institute, although a recent FDA report said these two forms of HPV cause more than 50% of cervical cancer cases.

Gardasil also is designed to combat two types of HPV that account for 90% of genital warts, Merck says.

The committee's vote helped push up Merck's stock 88 cents, or 2.6%, to $35.2 in heavier than average trading by late afternoon. Analysts say the vaccine could achieve sales of $1 billion or more annually in peak years.

Although Gardasil has been granted an accelerated review by the FDA, the agency has been known to take extra time in reviewing first-in-class products. For example, earlier this year, the FDA told Merck it would need an additional 90 days to review the company's application for Zostavax, the first vaccine against shingles. The agency is scheduled to act on Zostavax by May 25.

Any delay on Gardasil would give GlaxoSmithKline(GSK) more time to catch up with its Cervarix, a vaccine aimed at the two biggest cervical cancer-causing types of HPV. GlaxoSmithKline expects to file its application with the FDA by the end of the year. In March, it sought European Union approval for Cervarix.