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May 9, 2013 6:20 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the company has been awarded a significant portion
of the UNICEF human papillomavirus (HPV) vaccine tender, and will
provide sustained supply of GARDASIL^® [Human Papillomavirus
Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] to
GAVI-eligible countries. This agreement follows the GAVI Alliance’s
earlier announcement that HPV vaccines would be included in its
portfolio for the first time. GAVI is expected to support the
introduction of HPV vaccination in 28 countries by the end of 2017.

Through this initial tender award, Merck expects to supply approximately
2.4 million doses of GARDASIL to GAVI-eligible countries between 2013 to
2017 to help meet vaccine demand for countries already approved or
recommended for approval by GAVI for HPV vaccine demonstration projects
and national introductions. Additional awards by UNICEF are anticipated
as vaccine demand increases.

“It is essential that every young girl around the world have access to
HPV vaccines. Today’s decision by UNICEF is an important step forward,”
said Julie L. Gerberding, M.D., president, Merck Vaccines. “This
partnership highlights Merck’s commitment to working closely with GAVI
to ensure broad and sustained access to GARDASIL in the world’s poorest
countries, where the burden of cervical cancer is greatest.”

“A vast gap currently exists between girls in rich and poor countries.
With today’s announcement of GAVI’s programmes we can begin to bridge
that gap to help protect girls against cervical cancer no matter where
they are born,” said Dr. Seth Berkley, CEO of the GAVI Alliance. “By
2020 we hope to reach more than 30 million girls in more than 40
countries. This is a transformational moment for the health of women and
girls across the world. We thank the manufacturers for working with us
to help make this happen.”

Following a 2009 report, the World Health Organization recommended that
routine HPV vaccination be included in national immunization programs to
help prevent cervical cancer and other HPV-related diseases. It is
estimated that approximately 500,000 women develop cervical cancer
annually around the world, with about 85 percent of cases occurring in
developing countries. Cervical cancer is the third most common type of
cancer among women worldwide. High-risk HPV types 16 and 18 cause about
75 percent of cervical cancers, 70 percent of vaginal cancers, 40 to 50
percent of vulvar cancers and 80 percent of anal cancers.

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)
Vaccine, Recombinant] is indicated in the United States 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. GARDASIL is
also approved for use in boys and men 9 through 26 years of age for the
prevention of anal cancer 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 vaccines 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 [Human Papillomavirus
Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] 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.

About GARDASIL

GARDASIL is approved for use in more than 125 countries. To date, more
than 111 million doses have been distributed worldwide; however, it is
not known how many doses have been administered.

Other Merck access efforts for GARDASIL in the developing world

Merck is pursuing a systematic and thoughtful approach to improve access
to GARDASIL in the developing world through four key pillars:
innovation, partnerships, pricing and implementation. Key efforts
include:

• In September 2012, Merck announced it will donate 460,000 doses of
  GARDASIL over a two-year period to the Republic of Uganda to help the
  Ministry of Health launch a HPV vaccination program in 12 districts in
  the country. The program represents the first phase of Uganda’s
  national rollout plan for HPV vaccination.
• In April 2011, the Government of Rwanda, Merck and QIAGEN launched a
  comprehensive cervical cancer prevention program in Rwanda
  incorporating both HPV vaccination and HPV testing, the first program
  of its kind in Africa. In its initial year, an estimated 93 percent of
  eligible girls 12 to 15 years of age in Rwanda were vaccinated with
  three doses of GARDASIL.
• In 2010 Merck partnered with the Royal Government of Bhutan and the
  Australian Cervical Cancer Foundation to launch a six-year national
  vaccination program with GARDASIL for appropriate girls and young
  women between the ages of 12 and 18 in Bhutan. Merck provided GARDASIL
  to the program partners at no cost in the first year and for the
  remaining five years is providing it at an access price.
• In 2009 Merck also announced a partnership with QIAGEN N.V. focused on
  increasing access to HPV vaccination and HPV DNA testing in some of
  the most resource-poor areas of the world. This initiative was the
  first time a vaccine manufacturer and a molecular diagnostics company
  collaborated to help address the burden of cervical cancer with a
  comprehensive approach.
• Merck has also donated more than one million doses of GARDASIL [Human
  Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
  Recombinant] through the GARDASIL Access Program, which was
  established in 2007 to help enable organizations and institutions in
  eligible lowest income countries to gain operational experience
  designing and implementing HPV vaccination projects.

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. For
more information, visit www.merck.com
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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. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent 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 2012 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).

Please see Prescribing Information for GARDASIL^®
at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
and Patient Information for GARDASIL at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.

Merck
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