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Friday 28th October 2016

Six-year program provides vaccine for country's entire eligible population of 12 – 18 year old girls and young women

5th May 2010

The Royal Government of Bhutan, Merck (which is known as MSD outside the United States and Canada) and the Australian Cervical Cancer Foundation (ACCF) have launched a national vaccination program with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls and young women in Bhutan.  In an effort to reduce the burden of cervical cancer, which affects more women in Bhutan than any other cancer, girls and young women between the ages of 12 and 18 will be offered vaccination with GARDASIL as part of this initiative.

The six-year program led by Her Majesty the Royal Grandmother Ashi Kesang Choeden Wangchuck and the Bhutan Ministry of Health will provide vaccination with GARDASIL starting today.  Bhutan is the first low income country in the world to implement a national vaccination program with an HPV cancer vaccine.

"Vaccination programs such as the one we launched today play an important role in helping to protect the women of our country," said Dr. Ugen Dophu, director, Department of Public Health, Ministry of Health, Bhutan.  "It has long been a priority of ours to make health programs like this available to women of our country.  We’re pleased to have the support of Merck and the ACCF on such an important initiative."

Merck is providing GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], to the program partners at no cost in the first year and for the remaining five years will provide it at an access price at which Merck will not profit.  In addition, Merck is providing additional support for implementation of the program.  The Royal Government of Bhutan is committed to ensuring sustainability of this program beyond the six year partnership with Merck and ACCF.

 "Cervical cancer represents a significant public health problem for Bhutan and the impact on affected women, their families and their communities is great.  Merck is committed to helping improve access to GARDASIL in Bhutan and in other resource-limited countries around the world where the prevalence of cervical cancer is high," said Dr. Mark Feinberg, vice president, Medical Affairs and Policy, Merck Vaccines.  "Working in partnership with committed governments and other public and private sector partners is critical to the success of any program developed to enable women in low income countries to benefit from vaccination against cervical cancer."

ACCF is supporting this national vaccination program by providing financial support to the Royal Government of Bhutan to secure doses of GARDASIL at the access price after the first year of the program is complete.  This support is part of ACCF’s commitment to helping reduce cervical cancer in Australia and in low income countries.  Since its incorporation in 2007, the aim of ACCF has been to help facilitate access to HPV vaccines for young women and to help facilitate screening and treatment of cervical cancer and related women’s health issues in resource-limited countries in South Asia and the Asia–Pacific region.

"The desire of Her Majesty The Royal Grandmother to help prevent cervical cancer in Bhutanese women has inspired the Royal Government of Bhutan’s Ministry of Health, Merck and ACCF to achieve an extraordinary common goal and create an example for every nation of the powerful results possible for communities when organisations with different strengths work together in the right partnership," said Joe Tooma, CEO, Australian Cervical Cancer Foundation.

GARDASIL is approved in the US for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal 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.  GARDASIL is also approved in the US for use in boys and men ages 9 through 26 years of age for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11. HPV types 16 and 18 account for approximately 75% of cervical cancer cases.  GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Partnership focused on reducing incidence of cervical cancer

This landmark program demonstrates the Royal Government of Bhutan’s commitment to women’s health.  Bhutan is a country of approximately 650,000 people, and like many other resource-constrained countries, has a high rate of cervical cancer.  Based on current estimates from the World Health Organisation (WHO), approximately 200 women in Bhutan are diagnosed with cervical cancer each year and about one-half of those women die.  The national HPV vaccination program will complement the cervical cancer screening program in Bhutan that has proven successful in recent years.

Merck is pursuing a systematic approach to improve access to GARDASIL in the developing world through four key pillars: innovation, partnerships, pricing and implementation.  In 2007, Merck made a pledge to donate at least three million doses of GARDASIL through the charitable GARDASIL Access Program, which enables organizations and institutions in eligible lowest income countries to gain operational experience in the design and implementation of HPV vaccination projects.  In 2009, GARDASIL became the first cervical cancer vaccine to receive WHO prequalification.  In 2009 Merck also announced a partnership with QIAGEN NV focused on increasing access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world.  This initiative is the first time a vaccine manufacturer and a molecular diagnostics company are collaborating to address the burden of cervical cancer with a comprehensive approach.

Important information about GARDASIL 

GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

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, and vaginal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.

GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.

Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] protects only against those vulvar and vaginal cancers caused by HPV Types 16 and 18.

Select safety information

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.

HPV and cervical cancer

Human papillomavirus (HPV) is a widespread virus that is transmitted through sexual contact.  It is estimated that 7.9% of women in Southern Asia are infected with HPV at any given time. 

For most people, HPV will go away on its own.  But, for others whose immune systems do not clear certain types, HPV could cause significant consequences.

Many people who have HPV do not know it, because the virus often has no signs or symptoms.  Any genital contact with someone who has it puts a person at risk – intercourse is not necessary.  Condoms may not fully protect against HPV, as HPV can infect areas that are not covered by a condom.

When a woman is infected with certain types of HPV, and the virus does not go away on its own, abnormal cells can develop in the lining of the cervix.  If these abnormal cells are not found early and treated, precancers, and then cervical cancer – a cancer of the cervix (the lower part of the uterus that connects to the vagina) – can develop. There is no way to predict who will or will not clear the virus.

GARDASIL is approved in 120 countries

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] (sold in some countries as SILGARD®) has been approved in 120 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

About the Australian Cervical Cancer Foundtion

Australian Cervical Cancer Foundation is a charity whose mission is to minimize the incidence and burden of cervical cancer and related women’s health issues on women, their families and their communities, both in Australia and in developing countries by developing practical and appropriate programs and partnering with like-minded governments, organizations and individuals to achieve its aims.  ACCF thanks Merck for its interest and involvement in this extraordinary Bhutan project.  Over time, with resolve and commitment, ACCF aims to work towards fighting cervical cancer through screening and vaccination in developing countries where cervical cancer is the number one cancer killer of women.  For more information and to help support ACCF’s mission visit, www.accf.org.au.

About Bhutan and the Royal Government

Bhutan is a sovereign kingdom in the eastern Himalayas with a population of approximately 650,000.  The Royal Government of Bhutan has financed and provided free healthcare to its citizens since it embarked on an ambitious socio-economic development program about five decades ago.  Bhutan has made considerable improvements in the health status of its population through its Primary Health Care approach.

The Government is mandated under the Constitution to "provide free access to basic public health services in both modern and traditional medicines" and "endeavor to provide security in the event of sickness."  

The framework of the health system in Bhutan is embedded in the overall development philosophy of Gross National Happiness and to achieve the national goals of equity, social justice, sustainability and efficiency.

For more information, visit www.health.gov.bt.  For more information about the country's profile, demographic and socio-economic indicators, visit www.nsb.gov.bt.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. Merck. Be well. For more information, visit www.merck.com.

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, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; 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 US 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 2009 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).

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