MERCK FILES BLA FOR GARDASIL
Merck has filed its long-awaited biologic license (BLA) application for Gardasil,
an investigational cervical cancer vaccine considered by many observers to be
the most important near-term drug candidate in the company's pipeline.
Merck is seeking priority review for the BLA, which, if granted, would result
in a decision within six months, instead of the standard 10 months, the firm
said recently. Gardasil is designed to protect against four strains of human
papillomavirus (HPV) Types 16 and 18, which account for an estimated
70 percent of cervical cancer cases, and Types 6 and 11, which account for an
estimated 90 percent of genital wart cases.
Merck's application comes on the heels of a positive late-stage clinical trial
that showed Gardasil prevented virtually 100 percent of growths that can lead
to cervical cancer. In the Phase III study, known as Future II, Gardasil prevented
high-grade (the most serious) precancerous lesions and non-invasive cancers
in 97 percent to 100 percent of the 12,000 women who participated in the trial.
Bear Stearns analyst John Boris called the study results "compelling"
and predicted that annual U.S. sales of Gardasil could top $900 million by 2010.
The total market for cervical cancer vaccines is expected to be worth $4 billion
to $7 billion annually by 2010, according to analysts. Roughly 20 million U.S.
men and women are infected with HPV, certain types of which can cause cervical
cancer and genital warts.
Merck's announcement puts pressure on British rival GlaxoSmithKline (GSK), which
is also developing a cervical cancer vaccine. Last November, a study published
in British the medical journal The Lancet showed GSK's vaccine Cervarix
to also be virtually 100 percent effective against HPV 16 and 18.
GSK has not said when it plans to seek FDA approval for Cervarix, but Boris
said he did not expect a U.S. launch until 2008, "potentially providing
Gardasil with a two-year head start in the United States," and a "potentially
significant opportunity for Merck as it could allow the company to 'create'
the market and exploit Gardasil's profile," he said.
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