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December 11, 2014 5:30 pm ET

GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA)
approved GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine,
Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, for
use in girls and young women 9 to 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 approved for use in boys 9 to 15
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].

“With GARDASIL 9, the medical and public health community now has the
potential to help prevent 90 percent of cervical cancers caused by HPV,”
said Dr. Julie Gerberding, president, Merck Vaccines. “This is an
extraordinary opportunity to even further reduce the burden of
HPV-related diseases and cancers in males and females.”

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 85-90
percent of HPV-related vulvar cancers, 80-85 percent of HPV-related
vaginal cancers, and 90-95 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.

Not all vulvar, vaginal, and anal cancers are caused by HPV, and
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) protects
only against those vulvar, vaginal, and anal cancers caused by HPV 16,
18, 31, 33, 45, 52 and 58.

HPV vaccination is a public health priority in the United States

The U.S. Centers for Disease Control and Prevention (CDC) has made
increasing HPV vaccination rates a public health priority. According to
the CDC, HPV vaccination rates are unacceptably low compared to rates
for other adolescent vaccines, and the CDC estimated that an additional
53,000 cases of cervical cancer could be prevented in girls 12 years and
older over their lifetimes by increasing three-dose HPV vaccination
coverage to 80 percent. The CDC has also noted that for every year that
HPV vaccination rates do not improve, another 4,400 women will go on to
develop cervical cancer. The CDC and other leading public health
organizations, such as American Academy of Pediatrics (AAP) and National
Foundation for Infectious Diseases (NFID), encourage health care
providers to recommend HPV vaccine with the same sense of importance
used to recommend other adolescent vaccines in order to increase
vaccination rates and help protect more individuals against HPV-related
cancers and other diseases. Healthy People 2020 vaccination goals of 80
percent coverage for adolescents (13 to 15 years old) are near or have
been met for all routinely recommended vaccines except for HPV vaccine.
Merck anticipates that the CDC’s Advisory Committee on Immunization
Practices (ACIP) will vote on recommendations for use of GARDASIL 9 at
the February 2015 meeting.

“It’s remarkable to think that we now have a vaccine designed to help
prevent even more cases of cervical cancer,” said Elmar Joura, M.D.,
associate professor of gynecology and obstetrics, Medical University of
Vienna and Comprehensive Cancer Center, Vienna, Austria, and study
investigator for GARDASIL 9. “GARDASIL 9 will have a
significant impact in the fight against cervical, vaginal, vulvar and
anal cancers.”

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 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 provider.

In clinical studies, GARDASIL 9 demonstrated high efficacy
against the five additional HPV types

The clinical trial program for GARDASIL 9 was designed to build upon the
efficacy established in clinical trials with GARDASIL [Human
Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine,
Recombinant]. The initial clinical program that supported the licensure
of GARDASIL 9 began in 2007 and included five trials that evaluated more
than 12,000 individuals who received GARDASIL 9.

The efficacy of GARDASIL 9 in 16- through 26-year-old girls and women
was assessed in an active comparator-controlled, double-blind,
randomized clinical trial (Study 1) that included a total of 14,204
women (GARDASIL 9 = 7,099; GARDASIL = 7,105) who were enrolled and
vaccinated without pre-screening for the presence of HPV infection.
Participants were followed up with a median duration of 40 months (range
0 to 64 months) after the last vaccination. The primary comparison
between GARDASIL 9 and GARDASIL was clinical efficacy for the five
additional HPV types. Effectiveness of GARDASIL 9 against persistent
infection and disease related to the original four HPV types (6, 11, 16,
or 18) was inferred from non-inferiority comparisons. The primary
efficacy analysis was conducted in those who received all three doses of
vaccine within one year of enrollment, did not have major deviations
from the study protocol, were negative (PCR negative and seronegative)
to the relevant HPV type(s) prior to dose 1, and who remained PCR
negative to the relevant HPV type(s) through Month 7 (per-protocol
efficacy, or PPE, population).

The primary efficacy evaluation was based on a composite clinical
endpoint of HPV 31-, 33-, 45-, 52-, and 58-related cervical, vulvar, and
vaginal cancer, and high-grade cervical/vulvar/vaginal disease [CIN 2/3
(cervical intraepithelial neoplasia 2/3) or AIS (adenocarcinoma in
situ), VIN 2/3 (vulvar intraepithelial neoplasia 2/3), and VaIN 2/3
(vaginal intraepithelial neoplasia 2/3)]. Additional secondary endpoints
related to HPV 31, 33, 45, 52, and 58 were also evaluated. Efficacy for
all endpoints was measured starting after the Month 7 visit. In the PPE
population, GARDASIL 9 (Human Papillomavirus 9-valent Vaccine,
Recombinant) demonstrated:

• 96.7 percent efficacy (95% CI; 80.9, 99.8) against the combined
  incidence of cervical, vaginal, and vulvar cancers, CIN 2/3, AIS, VIN
  2/3, and VaIN 2/3 caused by HPV types 31, 33, 45, 52, 58 (1 case in
  the group that received GARDASIL 9 vs. 30 cases in the group that
  received GARDASIL).
• 98.6 percent efficacy (95% CI; 92.4, 99.9) against CIN 1 caused by HPV
  types 31, 33, 45, 52, 58 (1 case in the group that received GARDASIL 9
  vs. 69 cases in the group that received GARDASIL).
• 96.3 percent efficacy (95% CI; 79.5, 99.8) against CIN 2/3 or AIS
  caused by HPV types 31, 33, 45, 52, 58 (1 case in the group that
  received GARDASIL 9 vs. 27 cases in the group that received GARDASIL).
• 93.8 percent efficacy (95% CI; 61.5, 99.7) against vulvar or vaginal
  disease caused by HPV types 31, 33, 45, 52, 58 (1 case in the group
  that received GARDASIL 9 vs. 16 cases in the group that received
  GARDASIL).
• 96.2 percent efficacy (95% CI; 94.4, 97.5) against persistent HPV
  infection 6 months or longer with HPV types 31, 33, 45, 52, 58 (26
  cases in the group that received GARDASIL 9 vs. 642 cases in the group
  that received GARDASIL).
• 96.1 percent efficacy (95% CI; 93.7, 97.9) against persistent HPV
  infection
  12 months or longer with HPV types 31, 33, 45, 52, 58
  (15 cases in the group that received GARDASIL 9 vs. 375 cases in the
  group that received GARDASIL).
• 92.6 percent efficacy (95% CI; 89.7, 94.8) against abnormal Pap tests
  (ASC-US HR-HPV positive or worse) caused by HPV types 31, 33, 45, 52,
  58 (35 cases in the group that received GARDASIL 9 vs. 462 cases in
  the group that received GARDASIL).
• 96.9 percent efficacy (95% CI; 93.6, 98.6) against biopsy caused by
  HPV types 31, 33, 45, 52, 58 (7 cases in the group that received
  GARDASIL 9 vs. 222 cases in the group that received GARDASIL).
• 87.5 percent efficacy (95% CI; 65.7, 96.0) against definitive therapy
  related to HPV types 31, 33, 45, 52, 58 (4 cases in the group that
  received GARDASIL 9 vs. 32 cases in the group that received GARDASIL).

Effectiveness of GARDASIL 9 against persistent infection and disease
related to HPV types 6, 11, 16, or 18 was inferred from non-inferiority
comparisons of geometric mean titers (GMTs) in 16- through 26-year-old
girls and women following vaccination with GARDASIL 9 with those
following vaccination with GARDASIL [Human Papillomavirus Quadrivalent
(Types 6, 11, 16, and 18) Vaccine, Recombinant]. Antibody responses for
HPV 6, 11, 16, and 18 (measured by GMTs and seroconversion rates at
Month 7) for GARDASIL 9 among young women 16 to 26 years of age were
non-inferior to those who received GARDASIL. At least 99.7 percent of
individuals included in the analysis for each HPV type became
seropositive by Month 7.

Immunogenicity of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine,
Recombinant)

Prior vaccination strategies have shown that the ideal time to
administer a vaccine is before exposure to the infection. Immunogenicity
studies for GARDASIL 9 were used for the adolescent population (9- to
15-year-old girls and boys) because adolescents are not likely to have
been exposed to genital HPV types. Immunogenicity studies for GARDASIL 9
in adolescents (9- to 15-year-olds) are similar to that
previously established and used in the clinical program for GARDASIL as
a basis for licensure in this population.

Merck conducted two immunogenicity studies to support effectiveness of
GARDASIL 9 in adolescents. In Study 2, effectiveness of GARDASIL 9
against persistent infection and disease related to vaccine HPV types in
9- through 15-year-old girls and boys was inferred from non-inferiority
comparison of GMTs following vaccination with GARDASIL 9 among 9- to
15-year-old girls and boys with those among 16- through 26-year-old
girls and women. The primary analyses were conducted in the per-protocol
population, which included individuals who received all three
vaccinations within one year of enrollment, did not have major
deviations from the study protocol, and were HPV-naïve (seronegative to
the relevant HPV type(s) prior to dose 1 and among female subjects 16
through 26 years of age, PCR negative to the relevant HPV type(s) prior
to dose 1 through Month 7). In this study, anti-HPV GMTs at Month 7 for
GARDASIL 9 among 9- through 15-year-old girls and boys were non-inferior
to anti-HPV GMTs among 16- through 26-year-old women for all nine HPV
types.

In Study 3, effectiveness of GARDASIL 9 against persistent infection and
disease related to HPV types 6, 11, 16, or 18 was inferred from
non-inferiority comparisons of GMTs in 9- through 15-year-old girls
following vaccination with GARDASIL 9 with those following vaccination
with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and
18) Vaccine, Recombinant]. In the per-protocol population, anti-HPV 6,
11, 16, and 18 GMTs at Month 7 for GARDASIL 9 among girls 9 through 15
years of age were non-inferior to those who received GARDASIL. At least
99.7 percent of individuals included in the analyses for each HPV type
became seropositive by Month 7.

Across all clinical trials with GARDASIL 9, at least 99.5 percent of
individuals included in the analyses for each of the nine vaccine HPV
types became seropositive by Month 7. Anti-HPV GMTs at Month 7 among 9-
through 15-year-old girls and boys were comparable to anti-HPV responses
among 16- through 26-year-old women in the combined database of
immunogenicity studies for GARDASIL 9.

Safety of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine,
Recombinant)

The safety of GARDASIL 9 was evaluated in six clinical studies that
included more than 13,000 individuals. In clinical studies with GARDASIL
9:

• The most common (≥10%) local and systemic adverse reactions in females
  16
  through 26 years of age were injection-site pain (89.9%),
  injection-site swelling (40.0%), injection-site erythema (34.0%) and
  headache (14.6%).
• The most common (≥10%) local and systemic reactions in girls 9 through
  15 years of age were injection-site pain (89.3%) injection-site
  swelling (47.8%), injection-site erythema (34.1%) and headache (11.4%).
• The most common (≥10%) local and systemic reactions in boys 9 through
  15 years of age were injection-site pain (71.5%), injection-site
  swelling (26.9%), and injection-site erythema (24.9%).

Availability and CPT information for GARDASIL 9

Merck will begin taking orders for GARDASIL 9 and begin shipping product
in early February 2015. Merck anticipates that the CDC’s ACIP will vote
on recommendations for use of GARDASIL 9 and coverage under the Vaccines
for Children (VFC) program at the February 2015 meeting. Typically,
managed care coverage follows after the ACIP makes recommendations.

The American Medical Association has established a Current Procedural
Terminology (CPT)® code of 90651¹ for GARDASIL 9. CPT codes
allow for the identification and potential reimbursement of existing
common procedures, services and products’ new and emerging technologies,
as well as the collection of data to facilitate performance measures.

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)
Vaccine, Recombinant] continues to be available

Because many adolescents do not visit their health care provider every
year, it is important for health care providers to continue to vaccinate
with GARDASIL while awaiting ACIP recommendations and managed care
access for GARDASIL 9. GARDASIL is also available for males 16 to 26
years of age for whom GARDASIL 9 is not currently indicated.

Important Information about GARDASIL 9 (Human Papillomavirus 9-valent
Vaccine, Recombinant)

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 provider.

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

GARDASIL 9 has not been demonstrated to protect against diseases due to
HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical,
vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or 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 [Human Papillomavirus Quadrivalent (Types 6,
11, 16, and 18) Vaccine, Recombinant].

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 by maintaining a supine or Trendelenburg position.

Dosage and administration for GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)

GARDASIL 9 should be administered intramuscularly in the deltoid region
of the upper arm or in the higher anterolateral area of the thigh at the
following schedule: 0, 2 months, 6 months.

About HPV and related cancers and diseases

Human papillomavirus (HPV) causes virtually all cervical cancer cases.
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 genital warts in both
females and males. Approximately 575,000 cases of these HPV-related
cancers occur annually worldwide. Millions of cases of genital warts
occur worldwide each year in females and males.

Each day, another 33 women are diagnosed with cervical cancer in the
United States — about 12,000 women per year. Additionally, there are an
estimated 2.8 million abnormal Pap results, many of which are caused by
HPV, that require follow-up each year in the United States.

Anal cancer and genital warts affect both men and women. According to
the American Cancer Society, it is estimated that approximately 2,600
men and 4,500 women in the United States will be diagnosed with anal
cancer in 2014. There is no routine screening recommended for the
general population to reduce the risk of anal cancer. Approximately one
million cases of genital warts occur each year in the United States.
Treatment of genital warts can be painful, and they commonly recur after
treatment, especially in the first three months.

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
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
and connect with us on Twitter,
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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; 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 2013 Annual Report on Form 10-K and the company’s other
filings with the 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.

GARDASIL^®9 and GARDASIL^® are
registered trademarks of Merck & Co., Inc., Whitehouse Station, N.J.,
U.S.A.

____________________________________________

¹ CPT © 2014 American Medical Association. All Rights
Reserved. CPT is a registered trademark of the American Medical
Association. CPT codes are effective as of January 2015 as set forth in
the Current Procedural Terminology 2015.

Merck
Media:
Pamela Eisele, 267-305-3558
Deb Wambold, 215-652-2913
or
Investors:
Joseph Romanelli, 908-740-1986
Justin Holko, 908-740-1879