Business

Glaxo wins FDA approval for cervical cancer vaccine

Posted October 16, 2009 11:18 a.m. EDT
Updated October 16, 2009 1:49 p.m. EDT

GlaxoSmithKline (NYSE: GSK) says U.S. regulators have approved its vaccine Cervarix to prevent the leading cause of cervical cancer in women.

The approval from the Food and Drug Administration allows Glaxo to compete against against Merck's blockbuster vaccine Gardasil, which has been on the market here since 2006.

“The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women,” said Deirdre Connelly, resident for North American Pharmaceuticals at GSK, in a statement. “Immunization with a vaccine such as Cervarix – along with annual doctor visits and Pap tests – will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties.”

Cervarix already is approved in nearly 100 other countries, but had been delayed in the U.S. since 2007, when the FDA requested additional data from the company.

Also Friday, Merck said the FDA had approved its vaccine Gardasil to prevent genital warts in boys ages 9 to 26, a new use for a product already given to women to prevent cervical cancer.

Gardasil already is approved in women to block four strains of the human papilloma virus that cause the majority of cervical cancers and genital warts. Merck has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

HPV infects about 6 million people in the U.S. each year, mainly through sexual contact. It usually causes no symptoms although rare cases can develop into warts and cancer in both men and women.

FDA approval was based on clinical trial data gathered from more than 30 countries and nearly 30,000 girls and young women who received Carvarix.

The vaccine blocks the two main strains of the human papilloma virus that cause 75 percent of cervical cancer.

GSK expects Cervarix to be available for sale in the U.S. late this year. It has not yet set pricing.

GSK maintains its U.S. headquarters in Research Triangle Park, N.C. and employs some 4,000 people in the area.

There are more than 100 types of HPV, though about 15 are known to cause cervical cancer.

Cervarix's effectiveness against extra strains of the virus could help differentiate it Merck's Gardasil, which also protects against HPV 16 and 18, but not other cancerous strains.

Still, GSK is likely to face an uphill battle in the U.S. Besides an established brand, Merck's vaccine also defends against two other HPV types that cause 90 percent of genital warts, which Cervarix does not target.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The Whitehouse Station, N.J., company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

But sales have been slowing amid questions about the longevity of the vaccine's effect and its price tag of nearly $400.

Side effects with Cervarix were mostly mild, including pain and swelling at the injection site, fatigue and headache.

HPV infects about 6 million people in the U.S. each year, and is spread mainly through sexual contact. It usually causes no symptoms and goes away within two years, although rare cases can develop into warts and cancer in both men and women.

Last year, nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all deaths from cancer.