Glaxo's Cervarix vaccine faces further delay

By Ben Hirschler

LONDON (Reuters) - GlaxoSmithKline Plc does not expect to win U.S. approval for its key cervical cancer vaccine Cervarix until late 2009, marking a further delay for the product.

The delay, announced on Monday, is good news for Merck & Co Inc, which sells the rival blockbuster vaccine Gardasil. Its stock jumped 3 percent while Glaxo shares were flat in a sharply higher market for European drugmakers.

Glaxo said it had responded to outstanding questions about Cervarix raised by the U.S. Food and Drug Administration but had decided to augment its application with results from a further Phase III study, called HPV-008.

Data from this trial are expected to be submitted to the U.S. regulator in the first half of 2009 and an FDA decision on the application is anticipated up to six months later.

"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix," Barbara Howe, Glaxo's head of North American vaccine development, said.

Interim data from the HPV-008 study were filed in the original application for the vaccine in March 2007. Glaxo added it did not expect the FDA to require new clinical studies for approval.

Cervarix is arguably the most important new product for Glaxo this decade but its path to market in the United States has been problematic, with the FDA delaying approval last December, pending more information.

Glaxo said in February it would reply to the U.S. watchdog before the end of the second quarter.