The US Food and Drug Administration has accepted the biologics license application (BLA) for Merck's Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) and that the investigational cervical cancer vaccine will be given priority review by the agency. The FDA has informed Merck that the review goal date is June 8, 2006.

Since submission to the FDA in December, Merck has also submitted applications for Gardasil to additional regulatory agencies including those in the European Union and Australia, Mexico, Brazil, Argentina, Taiwan and Singapore, informs the company release.

Gardasil is Merck's investigational cervical cancer vaccine. Gardasil is designed to protect against four types of human papillomavirus (HPV): types 16 and 18, which account for an estimated 70 per cent of cervical cancer cases and HPV types 6 and 11, which account for an estimated 90 per cent of genital wart cases.

In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in Gardasil. The vaccine is also the subject of other third-party licensing agreements.

Gardasil is one of three late-stage vaccines at Merck.

Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in a half-million diagnoses and approximately 300,000 deaths each year. In the United States an estimated 10,000 new cases of cervical cancer were diagnosed in 2005 and there were approximately 3,700 deaths.

Merck & Co. Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.