The US FDA Vaccines and Related Biological Products Advisory Committee unanimously approved Gardasil®, Merck's recombinant vaccine against the human papilloma virus (HPV), a sexually-transmitted disease that can lead to cervical cancer in women.The committee also agreed that the data from Phase 2 and Phase 3 clinical trials prove Gardasil's safety and efficacy against other cervical, vulvar and vaginal lesions caused by HPV types 6, 11, 16 and 18 including genital warts. The vaccine got priority review earlier this year, and the full review will be completed by June 8, 2006. If approved (the FDA does not necessarily have to follow the advisory committee's recommendations), this will be the first and only vaccine to prevent cervical cancer, which afflicts approximately 10,000 women in the US annually, as well as other serious HPV-related diseases.

One thing that is not yet definite however, is how broadly the vaccine will be used. Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex. Merck also suggested using it in young boys, who cannot get cervical cancer, but play a role in controlling its prevalence.

On the business scene:

Some investors have been bidding up shares of MedImmune (nasdaq: MEDI - news - people ), the Gaithersburg, Md.-based maker of a drug for treating infections in premature infants, because the biotech has licensing agreements for key technology in the HPV vaccines of both Merck and GlaxoSmithKline, which is close behind with a similar preventative. Australia's CSL Limited, which is not traded in the U.S., may also receive a royalty.
Bernstein's Porges estimates that MedImmune could get $175 million in 2010 royalties from both vaccines, adding 46 cents to its earnings per share; that could be worth $7 to MedImmune shares, he says. Porges estimates 2010 worldwide sales of $3.3 billion for Gardasil, compared to $940 million for Glaxo's Cervarix.

Read more from Forbes, On Guard for Gardasil, and from Merck's press release.

[Photo: Institute of Human Virology]