Healthcare Industry News: GARDASIL
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 NationsNEW 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 announced today as Merck's commitment at the Clinton Global Initiative.
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 available to developing world nations at dramatically lower prices at 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 announced 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 approved 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 and 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 and director for international programs, Sabin Vaccine Institute. "The GARDASIL access program will empower resource-poor nations and their partners to develop programs to bring this critical vaccine to people in need."
To implement this program, Merck will establish a partnership with a non-governmental organization to establish 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 and ROTATEQ to the developing world," said Mark Feinberg, vice president, policy, public health and medical affairs, Merck Vaccines and Infectious Disease. "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 an 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 and low-grade cervical lesions, vulvar and vaginal precancers and 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 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 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), 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).
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.
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 adverse 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 adverse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported serious adverse 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 after 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 statistically 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 bronchospasm (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 administered at four- to 10-week intervals. The third dose should not be given after 32 weeks of age. ROTATEQ was approved 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 around 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 and technical support at no cost to PATH to support demonstration studies in India, Peru and Vietnam. These studies are designed to accelerate the availability of cervical cancer vaccines to resource scarce areas. Merck is also working with India's Council of Medical Research 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 research collaboration with CSL Limited of Australia 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 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 .
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, 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 Station, NJ, U.S.A.
ROTATEQ is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, U.S.A.
Prescribing information and patient product information for ROTATEQ® is attached and is also available at www.rotateq.com.
Prescribing information and patient product information for GARDASIL® is attached and is also available at www.GARDASIL.com.
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