Healthcare Industry News: GARDASIL
News Release - November 13, 2006
Merck Launches National Advertising Campaign for GARDASIL(R), Merck's New Cervical Cancer VaccineCampaign Highlights the Value of Vaccination and the Continued Importance of Screening
WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Merck & Co., Inc. announced today the launch of a national print, television and online advertising campaign for the world's first cervical cancer vaccine, GARDASIL® (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine). GARDASIL was approved by the FDA on June 8 - and provisionally recommended by the Advisory Committee on Immunization Practices (ACIP) on June 29 - for girls and women aged 9-26(1). GARDASIL is the world's first and only vaccine indicated for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. Adding to Merck's ongoing cervical cancer and HPV education efforts, the new campaign, called One Less, encourages females who are eligible for the vaccine to begin their vaccination series and to also continue to see their doctor for regular healthcare and screening.
One Less is the continuation of Merck's commitment to disease and vaccine education. GARDASIL is for girls and women ages 9-26 years of age. If these girls and women have already been infected with HPV, they may still benefit from GARDASIL because it is unlikely that they have been infected with all four types of the virus covered by the vaccine. To inform and encourage these girls and women, the campaign focuses on a strong and positive message that is designed to empower them to want to become (or help their daughters want to become) "one less" person who will battle cervical cancer.
The campaign also focuses on important information about GARDASIL. GARDASIL may not fully protect everyone, and GARDASIL does not prevent all types of cervical cancer, so ongoing cervical cancer screenings will be important. GARDASIL is not recommended for use in pregnant women and GARDASIL will not treat cervical cancer. GARDASIL can cause injection site-pain, -swelling, -itching and -redness as well as fever, dizziness or nausea. For more information about this campaign and to view the commercials, visit www.GARDASIL.com.
Committed to public awareness
In addition to One Less, Merck will continue to separately support HPV disease education including the Tell Someone and the Make the Connection multi-lingual disease awareness programs to ensure an understanding about the important link between cervical cancer and HPV and the need to continue regular screening. Merck also provides support and grant funding to national and local organizations to help disseminate disease information to broad and diverse audiences, including those with outreach to underserved communities.
Access to GARDASIL
There is broad private and public coverage for GARDASIL. Health insurers covering approximately 94 percent of privately insured lives in the U.S. (currently more than 100 insurance plans) have decided to reimburse GARDASIL. GARDASIL was added to the Vaccines for Children (VFC) Program on November 1. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new 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 aged 19 and older who are uninsured and who are unable to afford vaccines.
Merck is also actively working to accelerate the availability of GARDASIL in the developing world: Merck is working with PATH to develop HPV vaccination programs that will facilitate the introduction of GARDASIL to the most impoverished nations. This initiative is funded by a grant to PATH from the Bill & Melinda Gates Foundation. Merck has also announced a partnership with India's Council of Medical Research to study GARDASIL. Merck will make our new vaccines, including GARDASIL, available at dramatically lower prices to developing world countries.
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 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.
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.
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.
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), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).
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. It is estimated that in 2006, there will be approximately 9,700 new cases of cervical cancer and 3,700 deaths in the United States. In addition, 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 United States and an estimated 32 million cases occur worldwide. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, AIS (non-invasive cervical cancer), CIN 3, VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vaginal and vulvar lesions (CIN I, VIN I and VaIN I). 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.
Worldwide availability of GARDASIL
GARDASIL has been approved in more than 40 countries including the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil. Additional applications for GARDASIL are currently under review with regulatory agencies in more than 50 countries around the world.
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.
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 attached and is also available at www.GARDASIL.com.
(1) The ACIP 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.
GARDASIL® is a registered trademark of Merck & Co., Inc, Whitehouse Station, N.J., U.S.A.
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