Healthcare Industry News: S.A.
News Release - September 26, 2007
Merck to Donate Three Million Doses of Gardasil(R), its Cervical Cancer Vaccine, to Support Vaccination Programs in Lowest Income Nations
NEW YORK--(HSMN NewsFeed)--Merck & Co., Inc. today committed to donate at least three million doses of GARDASIL® (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine), the cervical cancer vaccine, for use in demonstration projects in lowest income nations throughout the world. The program, part of Merck's comprehensive approach to bringing newer vaccines to the developing world, waS.A.nounced today as Merck's commitment at the Clinton Global Initiative."By donating three million doses of GARDASIL over the next five years, we are committing to the vaccination of one million femaleS.A.ainst cervical cancer, a diS.A.e that takes the lives of nearly 250,000 women each year," said Margaret G. McGlynn, president, Merck VaccineS.A.d Infectious DiS.A.e. "Our company is fully committed to making GARDASIL available to those who need it and we will continue to work with our partners in the international community to develop suS.A.nable solutions to bring GARDASIL and other vaccines to the developing world." GARDASIL is proven to help protect against diS.A.es that are caused by four types of the human papillomavirus: HPV types 16 and 18 which cause 70 percent of cervical cancer cases, and HPV types 6 and 11 which cause 90 percent of genital wart cases.
Merck is pursuing a systematic approach to the global introduction of two of its vaccines, ROTATEQ® (rotavirus vaccine, live, oral pentavalent) and GARDASIL, and is committed to making both vaccineS.A.ailable to developing world nationS.A. dramatically lower priceS.A. which Merck will not profit. Merck has made an important stride toward making ROTATEQ available in the developing world through its partnership with the Nicaraguan Ministry of Health which waS.A.nounced at the Clinton Global Initiative in September 2006. This joint partnership marks the first time that a vaccine was introduced into a lowest income country in the same year it waS.A.proved by the U.S. Food and Drug Administration (FDA). Merck also continues to support GAVI initiatives designed to increase access to all vaccines, including rotavirus vaccines, in lowest income countries.
There are enormous challenges to achieving high immunization rates in developing world nations, and historically, there has been a significant delay between the introduction of new vaccines in developed countrieS.A.d when they are widely available in developing countries.
"Much progress is being made to shorten the delay, but HPV vaccination in the developing world has not yet been prioritized by the international community," said Ciro de Quadros, president emerituS.A.d director for international programs, Sabin Vaccine Institute. "The GARDASIL access program will empower resource-poor nationS.A.d their partners to develop programs to bring this critical vaccine to people in need."
To implement this program, Merck will eS.A.lish a partnership with a non-governmental organization to eS.A.lish formal criteria for the program and to review proposals from developing world nations working independently and/or with non-governmental organizations, governments, or international organizations. Merck will provide free doses of GARDASIL for use in these programs.
"This program is modeled on Merck's pioneering public-private partnerships that have brought Mectizan, our HIV medicineS.A.d ROTATEQ to the developing world," said Mark Feinberg, vice president, policy, public health and medical affairs, Merck VaccineS.A.d Infectious DiS.A.e. "In just the first year of Merck's collaboration with the government of Nicaragua, we demonstrated that a developing nation can successfully introduce a new vaccine as quickly as developed nations. For GARDASIL, we know that this program iS.A. interim step, and an important one that will create models of successful HPV vaccination in resource-poor countries." GARDASIL is indicated to help prevent cervical cancer, precancerouS.A.d low-grade cervical lesions, vulvar and vaginal precancerS.A.d genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18.
Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly 500,000 diagnoses each year. Merck launched GARDASIL, the world's first cervical cancer vaccine, in the U.S. and other developed world nations in 2006. Since that time, GARDASIL has been approved in 85 nations, including 12 of the lowest income countries. Worldwide, Merck has distributed more than 10 million doses of GARDASIL as of June 30, 2007.
Select safety and additional information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active subS.A.ces 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 S.A.dard 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 diS.A.e 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 (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), nauS.A.(4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).
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.A.ter the first dose and the third dose six monthS.A.ter the first dose.
Select safety and additional information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.
No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination.
More than 71,000 infants were evaluated in three placebo-controlled clinical trials. SeriouS.A.verse events occurred in 2.4 percent of recipients of ROTATEQ when compared to 2.6 percent of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia, reported aS.A.seriouS.A.verse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported seriouS.A.verse events for ROTATEQ compared to placebo were bronchiolitis (0.6 percent vs. 0.7 percent), gastroenteritis (0.2 percent vs. 0.3 percent), pneumonia (0.2 percent vs. 0.2 percent), fever (0.1 percent vs. 0.1 percent), and urinary tract infection (0.1 percent vs. 0.1 percent).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 dayS.A.ter each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6 percent vs. 42.8 percent). Adverse events that occurred at a S.A.istically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1 percent vs. 21.3 percent), vomiting (15.2 percent vs. 13.6 percent), otitis media (14.5 percent vs. 13.0 percent), nasopharyngitis (6.9 percent vs. 5.8 percent), and bronchoS.A.m (1.1 percent vs. 0.7 percent).
In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.
As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.
The first dose of ROTATEQ should be administered between six and 12 weeks of age, with the subsequent doseS.A.ministered at four- to 10-week intervals. The third dose should not be given after 32 weeks of age. ROTATEQ waS.A.proved by the FDA on February 3, 2006.
Through June 2007, Merck has distributed more than six million doses of ROTATEQ. ROTATEQ has been approved in more than 60 countrieS.A.ound the world.
Merck's Leadership in Bringing Vaccines to the Developing World
Through Merck's partnership with the Nicaraguan Ministry of Health, aimed at demonstrating the public health impact of a full rotavirus vaccination program, all infants born in Nicaragua in a three-year period will receive free doses of ROTATEQ. To date, more than 100,000 infants have been vaccinated with ROTATEQ in Nicaragua in the first year since this partnership was initiated. This program adds to the evidence base supporting the efforts of the global public health community to accelerate the introduction of routine rotavirus vaccination in resource-poor countries.
With regard to GARDASIL, Merck is providing vaccineS.A.d technical support at no cost to PATH to support demonstration studies in India, Peru and Vietnam. These studieS.A.e designed to accelerate the availability of cervical cancer vaccines to resource S.A.ce areas. Merck iS.A.so working with India's Council of Medical ReS.A.ch to study GARDASIL in India. In addition, Merck has ongoing clinical trials in patient populations relevant to the developing world.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and reS.A.ch 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 reS.A.ch-driven pharmaceutical company dedicated to putting patients first. ES.A.lished in 1891, Merck currently discovers, develops, manufactureS.A.d markets vaccineS.A.d 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 also 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 S.A.ement
This press release contains "forward-looking S.A.ements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These S.A.ementS.A.e based on management's current expectationS.A.d involve riskS.A.d uncertainties, which may cause results to differ materially from those set forth in the S.A.ements. The forward-looking S.A.ements may include S.A.ements regarding product development, product potential or financial performance. No forward-looking S.A.ement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking S.A.ement, whether aS.A.result of new information, future events, or otherwise. Forward-looking S.A.ements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factorS.A.d cautionary S.A.ements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
GARDASIL iS.A.registered trademark of Merck & Co., Inc., Whitehouse S.A.ion, NJ, U.S.A.
ROTATEQ iS.A.registered trademark of Merck & Co., Inc., Whitehouse S.A.ion, NJ, U.S.A.
Prescribing information and patient product information for ROTATEQ® iS.A.tached and iS.A.so available at www.rotateq.com.
Prescribing information and patient product information for GARDASIL® iS.A.tached and iS.A.so available at www.gardasil.com.
Source: Merck
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