FDAnews Drug Daily Bulletin

MERCK FILES BLA FOR GARDASIL

Dec. 7, 2005
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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.