Glaxo Resubmits Cervarix To U.S. Regulators

Shares in the world`s second largest drugmaker rose 1.3 percent after the news.

GlaxoSmithKline Plc has resubmitted its cervical cancer vaccine Cervarix to U.S. regulators, with the inclusion of final data from a pivotal Phase III study, it said on Monday.

The filing with the Food and Drug Administration clears the way for potential approval in the all-important U.S. market in around six months.

Shares in the world's second largest drugmaker rose 1.3 percent after the news.

Cervarix, which is already approved in more than 90 countries around the world, including major European markets, competes with Merck & Co Inc's Gardasil in protecting against the sexually transmitted cancer-causing human papillomavirus.

Glaxo is relying on Cervarix to drive future growth in its vaccines unit, which has been identified by Chief Executive Andrew Witty as a priority area and a target for bolt-on acquisitions.

But some analysts say its lengthy delay in winning U.S. approval means it will struggle against Merck's established product, which generated sales of $1.4 billion for the U.S. drugmaker in 2008.

Cervarix, meanwhile, sold a modest 125 million pounds ($177 million) last year.

The vaccine is a crucial new product for Glaxo but its path to market in the United States has been problematic, with the FDA delaying approval in December 2007, pending more information.

After that delay the company -- which had initially only filed interim data from the so-called HPV-008 study -- decided to wait until it had final results before resubmitting its application.

Monday's move to file the final data had been expected. Thomas Breuer, Glaxo's senior vice president for global clinical R&D, told Reuters last week that the group now had the full data needed for the resubmission.