Newswise — Merck & Co., Inc. announced today that the Company submitted a Biologics License Application (BLA) for GARDASIL® (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) to the U.S. Food and Drug Administration (FDA) on December 1, 2005. Merck also announced that it has plans to submit for licensure of GARDASIL in Australia and the European Union in December 2005; applications will be filed in other countries beginning in 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 the 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 percent of BLAs within 10 months of receipt, and to review and act on BLAs designated for priority review within six months of receipt.
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 percent of cervical cancer cases and HPV types 6 and 11 which account for an estimated 90 percent of genital wart cases.
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in GARDASIL. GARDASIL is also the subject of other third-party licensing agreements.
GARDASIL is one of three late-stage vaccines at Merck. In April, the Company submitted Biologics License Applications to the FDA for ROTATEQâ„¢, Merck's vaccine for rotavirus gastroenteritis, and ZOSTAVAXâ„¢ Merck's vaccine for zoster (shingles).
About Cervical Cancer, HPV and Genital WartsCervical 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 will be diagnosed in 2005. In most people, HPV goes away on its own. In some, however, certain high-risk types of HPV if unrecognized and untreated can lead to cervical cancer. Also, approximately one million cases of genital warts occur each year in the United States.
About MerckMerck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.
Forward-Looking StatementThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
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