Glaxo's Cervarix vaccine faces delays, concerns

WASHINGTON GlaxoSmithKline Plc's bid to sell its Cervarix cervical cancer vaccine in the United States faced further delay on Tuesday and the company recalled a batch of the vaccine in Britain following a teenager's death.

The U.S. Food and Drug Administration again postponed a decision on the British drugmaker's application, saying it needed more time to review the product. It was the second deferral by the agency since Glaxo sought approval in 2007.

The delay comes one day after news that a 14-year-old girl in Britain died shortly after receiving the shot, but Glaxo said there was no link between the FDA delay and that case.

"The FDA has not indicated that the extended review in the U.S. is related to that event or to any safety concern," Glaxo spokeswoman Sarah Alspach told Reuters.

British health officials are investigating the girl's case, but one official said a link between the death and the vaccine was unlikely. Glaxo said on Tuesday it was voluntarily recalling the batch of the vaccine that was used pending any findings.

FDA spokeswoman Shelly Burgess confirmed the agency had not approved Cervarix but had no comment on the death.

If approved, Cervarix would rival Merck & Co Inc's Gardasil. Both vaccines protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

But some analysts no longer see much chance for Glaxo's product to become the blockbuster, as once hoped, given Merck's three-year lead in the U.S. market.

Merck's Gardasil product won FDA clearance in 2006. Glaxo filed for approval a year later but the agency asked the company for more data in December 2007.

It was not immediately clear what issues the FDA still wanted to review. Earlier this month, an agency panel of outside experts overwhelmingly backed Cervarix as safe and effective for girls and women ages 10 to 25.

Panelists had expressed concern about reported miscarriages and a small number of autoimmune problems such as rheumatoid arthritis and lupus, and called for monitoring such issues after approval.

SUPPORT IN JAPAN

In Japan, however, Glaxo is on track to be first with its vaccine and is expecting a final approval decision within a month. On Tuesday, an advisory panel to Japan's Health Ministry backed Cervarix.

Still, that may not help Glaxo thwart global sales of Gardasil, which is also awaiting approval in Japan.

While both vaccines are approved in roughly 100 countries, Glaxo's Cervarix saw annual sales of 125 million pounds ($199 million) in 2008 worldwide compared with sales of Merck's Gardasil at $1.4 billion in 2008.

Cervarix and Gardasil are given in a series of three shots over six months to fight two HPV strains that cause about 70 percent of cervical cancers. But Gardasil also targets two other HPV strains that cause genital warts.

Merck's vaccine has also generated controversy over sometimes reported side effects including headaches, vomiting, fainting and in some cases seizure-like activity. The FDA and the U.S. Centers for Disease Control and Prevention have said Gardasil remains safe.

While cervical cancer is often caught early enough for treatment in the United States through Pap smear tests, some 4,000 U.S. women still die from the disease each year. Worldwide deaths total about 280,000, mostly in developing countries without much screening.

(Reporting by Susan Heavey; editing by Tim Dobbyn)