Merck & Co. Inc. has submitted a biologics license application (BLA) for Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) to the US Food and Drug Administration. Merck has plans to submit for licensure of Gardasil in the European Union and Australia, as well as other agencies, in December 2005 and early 2006.

Within 60 days following submission, the FDA will determine whether it will accept for review Merck's application as submitted. Merck is seeking priority review designation for Gardasil. Under the prescription drug user fee act (PDUFA), for standard BLAs filed in 2005, the FDA's goal is to review and act on 90 per cent of BLAs within 10 months of receipt, and to review and act on BLAs designated for priority review within six months of receipt, states a Merck 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. It 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.