Merck tries again for Gardasil expansion

Merck hasn't given up on broader use of its HPV vaccine in women. The company has delivered a new batch of info to the FDA in support of Gardasil use in women aged 27 to 45. The vaccine--which wards off two strains of the virus that cause cervical cancer and two others that spawn genital warts--is already OK'd for marketing to females from 9 years to 26 years.

Merck recently won another indication for Gardasil: For use in boys and young men to prevent genital warts. That's a nice expansion, but lacks the urgency that cancer prevention lends to use in females. Limited to marketing to women under 26--and now young males--Merck has seen Gardasil sales drop. Globally, revenues from the vaccine fell 22 percent, Reuters reports, to $311 million in Q3 of 2009.

Meanwhile, Merck has been trying to stay one step ahead of GlaxoSmithKline and its Cervarix shot, which won the FDA nod last year. Competition from Cervarix is one reason why Gardasil sales have slipped.

All of this is why Merck is so doggedly pursuing the chance to market Gardasil to more adult women. It's been turned down twice; most recently, FDA said it wouldn't approve the new indication without data from a 48-month study. And that's the trial data Merck delivered, before the end of 2009. News could come around midyear, because FDA tends to take around six months to review supplemental data, the company said.

- read the Reuters piece [1]

Related Articles:
Gardasil for boys not cost-effective [2]
Gardasil debate shifts as attention turns to boys [3]
Vax advisors stick to the sidelines in new Gardasil debate [4]
Study: HPV vax may also prevent cancer in men [5]