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June 13, 2018 5:45 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review a new supplemental Biologics License Application
(sBLA) for GARDASIL
^®
9 (Human Papillomavirus 9-valent
Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The
application is seeking approval for an expanded age indication for
GARDASIL 9 for use in women and men ages 27 to 45 for the prevention of
certain cancers and diseases caused by the nine human papillomavirus
(HPV) types covered by the vaccine. The FDA has granted Priority Review
to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or
target action, date of Oct. 6, 2018.

“Women and men ages 27 to 45 continue to be at risk for acquiring HPV,
which can lead to cervical cancer and certain other HPV-related cancers
and diseases,” said Dr. Alain Luxembourg, director, clinical research,
Merck Research Laboratories. “We look forward to working with the FDA on
the review of this application for GARDASIL 9, which, if approved, would
enable more people to have access to the vaccine.”

GARDASIL 9 is a vaccine indicated in the U.S. in females 9 through 26
years of age for the prevention of cervical, vulvar, vaginal, and anal
cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58;
pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18,
31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.
GARDASIL 9 is also indicated in males 9 through 26 years of age for the
prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52,
and 58; precancerous or dysplastic lesions caused by HPV types 6, 11,
16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6
and 11.

GARDASIL 9 is contraindicated in individuals with hypersensitivity,
including severe allergic reactions to yeast, or after a previous dose
of GARDASIL 9 or GARDASIL^® [Human Papillomavirus Quadrivalent
(Types 6, 11, 16, and 18) Vaccine, Recombinant].

About GARDASIL

^®

9 (Human Papillomavirus
9-valent Vaccine, Recombinant)

GARDASIL 9 includes the greatest number of HPV types in any available
HPV vaccine. After HPV types 16 and 18, the five additional HPV types in
GARDASIL 9 are the most common cervical cancer-causing types worldwide.
Seven HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause
approximately 90 percent of cervical cancer cases and approximately 80
percent of high-grade cervical lesions (cervical precancers, defined as
CIN 2, CIN 3 and AIS) worldwide. These seven HPV types also cause 90
percent of HPV-related vulvar cancers, 85 percent of HPV-related vaginal
cancers, and 90 percent of HPV-related anal cancers. HPV types 6 and 11
cause approximately 90 percent of genital warts cases. In addition,
approximately 50 percent of cases of low-grade cervical lesions (CIN 1)
are caused by the nine HPV types included in the vaccine.

GARDASIL 9 is approved for use in more than 70 countries.

Important information about GARDASIL 9

GARDASIL 9 does not eliminate the necessity for women to continue to
undergo recommended cervical cancer screening. Recipients of GARDASIL 9
should not discontinue anal cancer screening if it has been recommended
by a health care professional.

GARDASIL 9 has not been demonstrated to provide protection against
diseases from vaccine HPV types to which a person has previously been
exposed through sexual activity.

GARDASIL 9 is not a treatment for external genital lesions; cervical,
vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia
(CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial
neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Not all vulvar, vaginal, and anal cancers are caused by HPV, and
GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers
caused by HPV 16, 18, 31, 33, 45, 52, and 58.

Vaccination with GARDASIL 9 may not result in protection in all vaccine
recipients.

Select Safety Information for GARDASIL 9

GARDASIL 9 is contraindicated in individuals with hypersensitivity,
including severe allergic reactions to yeast, or after a previous dose
of GARDASIL 9 or 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 HPV
vaccination. When syncope is associated with tonic-clonic movements, the
activity is usually transient and typically responds to restoring
cerebral perfusion.

Safety and effectiveness of GARDASIL 9 have not been established in
pregnant women.

The most common (≥10%) local and systemic adverse reactions in females
were injection-site pain, swelling, erythema, and headache. The most
common (≥10%) local and systemic reactions in males were injection-site
pain, swelling, and erythema.

The duration of immunity of GARDASIL 9 has not been established.

Dosage and administration for GARDASIL 9

GARDASIL 9 should be administered intramuscularly in the deltoid region
of the upper arm or in the higher anterolateral area of the thigh.

• For individuals 9 through 14 years of age, GARDASIL 9 can be
  administered using a
  2-dose or 3-dose schedule. For the 2-dose
  schedule, the second dose should be administered 6-12 months after the
  first dose. If the second dose is administered less than 5 months
  after the first dose, a third dose should be given at least 4 months
  after the second dose. For the 3-dose schedule, GARDASIL 9 should be
  administered at
  0, 2 months, and 6 months.
• For individuals 15 through 26 years of age, GARDASIL 9 is administered
  using a
  3-dose schedule at 0, 2 months, and 6 months.

About HPV and HPV-related cancers and diseases

In the United States, human papillomavirus (HPV) will infect most
sexually active males and females in their lifetime. According to the
CDC, there are approximately 14 million new genital HPV infections in
the United States each year, half of which occur in people 15 through 24
years of age. For most people, HPV clears on its own, but for others who
don’t clear the virus it could lead to certain cancers and other
diseases in males and females. There is no way to predict who will or
won’t clear the virus.

HPV causes virtually all cervical cancer cases. Each day, about 36 women
are diagnosed with cervical cancer in the United States — about 13,200
women per year. HPV also causes approximately 70-75 percent of vaginal
cancer cases and approximately 30 percent of vulvar cancer cases in
females, and approximately 85-90 percent of anal cancers and 90 percent
of genital warts in both females and males.

Anal cancer and genital warts affect both men and women. According to
the American Cancer Society, an estimated 2,960 men and 5,620 women in
the United States will be diagnosed with anal cancer in 2018, and
overall rates have been increasing. There is no routine screening
recommended for the general population to reduce the risk of anal
cancer. Approximately 355,000 cases of genital warts occur each year in
the United States. Approximately 3 out of 4 people get them after having
genital contact with someone who has genital warts.

About Merck

For more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. Through our prescription
medicines, vaccines, biologic therapies 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 health care through far-reaching policies, programs
and partnerships. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and
connect with us on Twitter, Facebook, Instagram, YouTube
and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. 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; the company’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 the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2017 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

^®

9
(Human Papillomavirus 9-valent Vaccine, Recombinant) at 
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
.

The Patient Product Information for GARDASIL 9 is also available at 
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.

Merck
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or
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