Merck's Gardasil not cleared for older women

By Lewis Krauskopf

NEW YORK (Reuters) - U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday.

Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration said in a letter regarding the application that it has completed its review and there are "issues" that preclude approval within the expected review time frame, Merck said.

"It's hard to get a feel for if this is a dead issue or if this is delayed," said Linda Bannister, an analyst for Edward Jones. "At the minimum, it's going to be delayed."

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papillomavirus that causes cervical cancer. The company for now is dropping plans to pursue that expansion, a spokeswoman said.

Shares of the New Jersey-based drug maker, which also reiterated its long-term revenue and earnings targets, fell 0.8 percent.

Gardasil, approved in June 2006 for preventing cervical cancer and genital warts in females ages 9-26, has been one of Merck's most successful newer products and has helped the company recover after the 2004 withdrawal of its Vioxx arthritis treatment.

The Gardasil setbacks could raise concerns about the degree of growth that Merck can hope to achieve with the product, which is the world's first vaccine to prevent cervical cancer.

A Merck spokeswoman said the agency has specific questions regarding Gardasil's effectiveness in this older age group.