Merck seeks Gardasil OK
TRENTON, N.J. - Drug maker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers.
The application was submitted in late December, a Merck spokeswoman said yesterday.
It was long planned as part of Merck's strategy to increase the market for Gardasil. It prevents infection of the sexually transmitted virus and thus cancers of the genitals.
Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance.
However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen.
Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s.