Healthcare Industry News: ROTATEQ
News Release - February 7, 2006
GARDASIL(R), Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug AdministrationWHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Feb. 7, 2006--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for 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. A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), for BLAs filed in 2005, the FDA's goal is to review and act on BLAs designated as priority review within six months of receipt. 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.
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.
About Cervical Cancer, HPV and Genital Warts
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. 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. In addition, certain low-risk types of HPV cause genital warts. Approximately one million cases of genital warts occur each year in the United States. Additionally, there are an estimated 4.7 million abnormal Pap results each year in the United States which require follow up. At least three million of these results are caused by some type of HPV.
GARDASIL is one of three late-stage vaccines at Merck. In April, the Company submitted a Biologics License Application to the FDA for ZOSTAVAX®, Merck's vaccine for zoster (shingles) and ROTATEQ®, Merck's vaccine for rotavirus gastroenteritis. ROTATEQ was approved by the FDA on February 3 for the prevention of rotavirus gastroenteritis.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. 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 www.merck.com.
This 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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