Supplemental Application for GARDASIL, Merck's Cervical Cancer Vaccine, Designated Priority Review by the U.S. FDA for Use in Women 27 through 45
3/19/2008
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted, and designated for priority review, the supplemental Biologics License Application (sBLA) for GARDASIL® [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] for the potential use in women aged 27 through 45. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA’s goal is to review and act on 90 percent of BLAs designated as priority review within six months of receipt.
GARDASIL is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. Women remain at risk for newly acquired HPV infections and developing HPV-related diseases throughout their lifetime.
Additional important information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. GARDASIL is not recommended for use in pregnant women.
Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
GARDASIL is widely available throughout the United States
There is broad private and public health insurance coverage for GARDASIL. Health plans covering approximately 98 percent of privately insured lives in the U.S. (currently more than 140 insurance plans) have implemented coverage for GARDASIL; however, individual benefit coverage and rates provided by health plans may vary.
GARDASIL was also added to the Vaccines for Children (VFC) Program on Nov. 1, 2006, providing coverage for many who do not have private health insurance. All of the 55 immunization projects in the U.S. have adopted GARDASIL and most are filling provider orders. Merck has a patient assistance program for vaccines. Through this program, currently available in private physicians’ offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals ages 19 and older who are uninsured and who are unable to afford vaccines.
GARDASIL is approved in 100 countries
GARDASIL (sold in some countries as SILGARD®) has been approved in 100 countries, including the U.S., the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world. Merck will donate free vaccine to the non-profit organization PATH to support demonstration studies designed to accelerate the availability of cervical cancer vaccines in the most impoverished nations. PATH is funded by a grant from the Bill & Melinda Gates Foundation. Merck is working with India's Council of Medical Research to study GARDASIL in India. At the 2007 Clinton Global Initiative, Merck committed to donate at least three million doses of GARDASIL to support vaccination programs in the lowest income nations. Merck will make its newer vaccines, including GARDASIL, available to developing world countries at a no-profit price.
Human papillomavirus and cervical cancer
In the U.S. alone, approximately 6.2 million men and women become infected with HPV every year and approximately 20 million people are currently infected. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer and HPV 6 and 11 cause approximately 90 percent of genital warts cases. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 280,000 deaths each year. In 2007, there were an estimated 11, 000 new cases of cervical cancer and 3,600 deaths in the U.S. Approximately 6,000 cases of vulvar or vaginal cancer are diagnosed annually in the U.S. HPV-related diseases, including screening, follow up and treatment, costs about $5 billion per year in the U.S. HPV 16 and 18 cause an important proportion of these lesions and related costs.
Certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately one million cases of genital warts occur each year in the U.S. and an estimated 32 million cases occur worldwide. Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the U.S. At least 3 million of these results are caused by some type of HPV.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
About Merck
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.
Forward-Looking Statement
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 risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.