Healthcare Industry News: vulvar intraepithelial neoplasia
News Release - June 29, 2006
Merck's New Cervical Cancer Vaccine, GARDASIL(R), Unanimously Recommended by CDC Advisory Panel for Vaccination of Girls and Women 11 to 26 YearsWHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--June 29, 2006--Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that girls and women 11 to 26 years old be vaccinated with GARDASIL® (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) to prevent cervical cancer, precancerous and low-grade lesions, and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18. The Committee recommended that GARDASIL be administered to 11- and 12- year-old females and to females aged 13 to 26 who have not previously been vaccinated, and that nine- and 10-year-old females can be vaccinated with GARDASIL at the discretion of their physicians. The ACIP stated that Pap and HPV screening prior to vaccination are not necessary. The ACIP also recommended that females can receive GARDASIL regardless of whether they have or previously had an abnormal Pap test, a positive HPV test or genital warts.
On June 8, the Food and Drug Administration (FDA) approved GARDASIL, the only vaccine available in the U.S. for the prevention of HPV types 16- and 18-related cervical cancer, for use in girls and women ages nine to 26 years. GARDASIL is a ready-to-use, three dose, intra muscular vaccine. The FDA approved GARDASIL for the prevention of cervical cancer; cervical pre-cancers (cervical intraepithelial neoplasia (CIN) 2/3 and adenocarcinoma in situ (AIS)); vulvar pre-cancers (vulvar intraepithelial neoplasia (VIN) 2/3); and vaginal pre-cancers (vaginal intraepithelial neoplasia (VaIN) 2/3) caused by HPV types 16 and 18. GARDASIL is also approved for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.
"Merck is pleased that the ACIP has endorsed the use of GARDASIL to protect adolescent girls and young women from the potentially serious consequences of HPV infection," said Mark Feinberg, M.D., Ph.D., vice president of Policy, Public Health and Medical Affairs, Merck Vaccines. "GARDASIL was specifically designed to reduce the majority of HPV-related clinical diseases, those caused by HPV types 6, 11, 16 and 18, and this recommendation from the ACIP will help to ensure that this vaccine can do just that for many girls and young women."
CDC adds GARDASIL to the Vaccines for Children (VFC) program
During today's meeting, the ACIP also voted to add GARDASIL to the CDC's Vaccines for Children (VFC) program. Since 1994, the VFC program has provided vaccines to children who are Medicaid-eligible, uninsured, underinsured(1) and Native American. After the ACIP has made a recommendation for the use of a given vaccine, the Committee votes on whether the vaccine should be included in the VFC program. Eligible children may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine have been completed.
Merck has also created a new patient assistance program for vaccines. Through this new program, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck vaccines, including GARDASIL, will become available through this program in the third quarter of 2006.
About the Advisory Committee on Immunization Practices (ACIP)
The ACIP develops written recommendations for the routine administration of vaccines to children and adults, along with schedules regarding the appropriate dosage and dosing frequency, and contraindications applicable to the vaccines. The goals of the Committee, which consists of 15 experts in immunization and related fields, are to provide advice which will assist the CDC and the nation in reducing the incidence of vaccine-preventable diseases and to increase the safe usage of vaccines and related biological products. The ACIP recommendations do not result in requirements for vaccine administration by individual states or coverage by insurance companies. However, state health authorities and private insurers typically follow the Committee's guidance.
Dosage and administration for GARDASIL
GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper 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.
Selected 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.
As with any vaccine, 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, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine HPV types. 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. Vaccine-related adverse experiences that were observed in clinical trials 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 (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), and pruritis (3.1 percent vs. 2.8 percent).
Worldwide Availability of GARDASIL
On June 1, GARDASIL was approved in Mexico and on June 16, GARDASIL was approved in Australia. Applications for GARDASIL are currently under review with regulatory agencies worldwide, including but not limited to agencies in Argentina, Brazil, the European Union, New Zealand, Singapore and Taiwan. Additionally, Merck is actively working to accelerate the availability of GARDASIL in the developing world: in December, Merck announced a partnership with India's Council of Medical Research to study GARDASIL. Merck is also working with PATH and the Gates Foundation to develop HPV vaccination programs that will facilitate the introduction of GARDASIL to the most impoverished nations.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
About HPV Disease
In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. 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. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. In addition, certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately 1 million cases of genital warts occur each year in the United States 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 United States. At least 3 million of these results are caused by some type of HPV. HPV related disease, including screening, follow-up and treatment, costs about $5 billion per year in the U.S. Used in conjunction with screening, GARDASIL can help significantly reduce the human and economic burden of cervical cancer and other HPV-related diseases in the United States.
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, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
Prescribing information and patient product information for GARDASIL® is available at www.gardasil.com.
(1) Underinsured children receive VFC vaccines at Federally Qualified Health Centers.
GARDASIL® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
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