Merck has announced that its investigational cervical cancer vaccine, Gardasil® (quadrivalent human papillomavirus recombinant vaccine), will be given priority review by the US FDA. A Biologics License Application has been filed, and, with the expedited processing (standard is 10 months), the review may be concluded by June 8, 2006.

Gardasil is designed to protect against four types of human papillomavirus (HPV):

• types 16 and 18, which account for an estimated 70 percent of cervical cancer cases and
• HPV types 6 and 11, which account for an estimated 90 percent of genital wart cases.

According to the National Cervical Cancer Coalition, cervical cancer is the number one cause of cancer-related deaths among women in developing coountries, who account for about 85% of cervical cases worldwide, resulting to approximately 300,000 deaths each year. Additionally, certain low-risk types of HPV cause genital warts, which accounts for approximately one million cases each year in the United States alone.

Merck has also submitted applications for Gardasil to additional regulatory agencies in the European Union, Australia, Mexico, Brazil, Argentina, Taiwan and Singapore.

Gardasil is cited by Forbes to be one of the next drugs to watch, estimating its potential at $500 million to $1 billion in annual sales.