Merck Partners with Susan G. Komen for the Cure® on Historic Initiative to Help Address Cervical and Breast Cancer in Developing Nations
September 13, 2011 8:03 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that it is contributing $3 million over three years to the Pink Ribbon–Red Ribbon initiative to help address both cervical and breast cancer in sub-Saharan African nations by supporting disease education, screening and treatment efforts as well as increased access to cervical cancer vaccination. This contribution is in addition to Merck’s commitment to support a national cervical cancer vaccination program in Tanzania, which will soon be initiated by the Ministry of Health. Merck is a founding corporate partner of the Pink Ribbon–Red Ribbon initiative.
“Helping to reduce the burden of cervical cancer is an important global priority and one that we should all care deeply about,” said Julie L. Gerberding, president, Merck Vaccines. “Merck is proud to be a founding member of this ground breaking initiative that has the potential to help so many.”
Pink Ribbon–Red Ribbon is a historic initiative that brings together Susan G. Komen for the Cure, the George W. Bush Institute, the President’s Emergency Plan for AIDS Relief (PEPFAR), UNAIDS, the U.S. government and a number of corporate partners.
The goal of Pink Ribbon-Red Ribbon is to help reduce the number of women in Africa impacted by cervical and breast cancer and help increase access to breast healthcare and clinical exams in a number of African nations. Beginning in sub-Saharan Africa, the program will leverage the significant investments already made in the HIV/AIDS and infectious diseases infrastructure to deliver resources that support disease education, screening and treatment efforts as well as increased access to cervical cancer vaccination.
Through this three-year partnership, Merck will work with Susan G. Komen for the Cure to support the launch and first phase of the program, which will raise awareness about the burden of breast and cervical cancer, mobilize additional program partners and donors, advocate for increased access to screening, treatment and cervical cancer vaccination as well as promote follow-up care among women in sub-Saharan Africa. There are plans for the program to be replicated in other countries after three years. In addition, Merck has committed to provide approximately 3.6 million doses of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], at no cost, to the national cervical cancer vaccination program in Tanzania.
In the United States, GARDASIL is approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
Important Information about GARDASIL
GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia.
GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.
Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal and anal cancers caused by HPV Types 16 and 18.
Select safety information for GARDASIL
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.
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 deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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.
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Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships, Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Prescribing Information and Patient Product Information for GARDASIL® are available at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf
Pam Eisele, 908-423-5042
Jennifer Allen Woodruff, 215-652-0572
Carol Ferguson, 908-423-4465