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September 29, 2017 5:55 am ET

Company to Focus on Maximizing the Potential of ZEPATIER ^® (Elbasvir and Grazoprevir)

Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced its strategic decision to discontinue the development of
the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/
uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of
chronic hepatitis C virus (HCV) infection. This decision was made based
on a review of available Phase 2 efficacy data and in consideration of
the evolving marketplace and the growing number of treatment options
available for patients with chronic HCV infection, including ZEPATIER^®
(elbasvir and grazoprevir).

“Remarkable progress has been made in the fight against hepatitis C
infection, and Merck is enormously proud of the role we have had in that
fight over the past 30 years,” said Dr. Eliav Barr, senior vice
president, global clinical development, infectious diseases and
vaccines, Merck Research Laboratories. “We will continue to study
ZEPATIER to understand even more about its role in treating chronic
hepatitis C infection and will continue to work with others to help
bring ZEPATIER to appropriate patients with chronic hepatitis C genotype
1 or 4 infection, the genotypes which make up the majority of patients
with chronic hepatitis C infection.”

About ZEPATIER

ZEPATIER is indicated for the treatment of chronic HCV genotype (GT) 1
or 4 infection in adults. ZEPATIER is indicated for use with ribavirin
in certain patient populations.

Selected Safety Information about ZEPATIER

The US Prescribing Information for ZEPATIER contains a Boxed Warning
about the risk of hepatitis B virus (HBV) reactivation in patients
coinfected with HCV and HBV. Healthcare professionals should test all
patients for evidence of current or prior HBV infection by measuring
hepatitis B surface antigen (HBsAg) and hepatitis B core antibody
(anti-HBc) before initiating treatment with ZEPATIER. HBV reactivation
has been reported in HCV/HBV coinfected patients who were undergoing or
had completed treatment with HCV direct-acting antivirals and were not
receiving HBV antiviral therapy. Some cases have resulted in fulminant
hepatitis, hepatic failure, and death. Healthcare professionals should
monitor HCV/HBV coinfected patients for clinical and laboratory signs of
hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Healthcare professionals should initiate
appropriate patient management for HBV infection as clinically indicated.

HBV reactivation has been reported in HBsAg positive patients and also
in patients with serologic evidence of resolved HBV infection (ie, HBsAg
negative and anti-HBc positive). The risk of HBV reactivation may be
increased in patients receiving some immunosuppressant or
chemotherapeutic agents. HBV reactivation is characterized as an abrupt
increase in HBV replication manifesting as a rapid increase in serum HBV
DNA level. In patients with resolved HBV infection, reappearance of
HBsAg can occur. Reactivation of HBV replication may be accompanied by
hepatitis, ie, increases in aminotransferase levels and, in severe
cases, increases in bilirubin levels, liver failure, and death can occur.

ZEPATIER (elbasvir and grazoprevir) is not for use in patients with
moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is
also not for use with inhibitors of organic anion transporting
polypeptides 1B1/3 (OATP1B1/3) that are known or expected to
significantly increase grazoprevir plasma concentrations (e.g.,
atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine),
strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine,
phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER
(elbasvir and grazoprevir) is administered with RBV, healthcare
professionals should refer to the prescribing information for RBV as the
contraindications, warnings and precautions, adverse reactions and
dosing for RBV also apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the
upper limit of normal (ULN) occurred in 1% of subjects, generally at or
after treatment week 8. These late ALT elevations were typically
asymptomatic and most resolved with ongoing or completion of therapy.
Healthcare professionals should perform hepatic lab testing on patients
prior to therapy, at treatment week 8, and as clinically indicated. For
patients receiving 16 weeks of therapy, additional hepatic lab testing
should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional
without delay if they have onset of fatigue, weakness, lack of appetite,
nausea and vomiting, jaundice or discolored feces. Healthcare providers
should consider discontinuing ZEPATIER (elbasvir and grazoprevir) if ALT
levels remain persistently greater than 10 times ULN. ZEPATIER should be
discontinued if ALT elevation is accompanied by signs or symptoms of
liver inflammation or increasing conjugated bilirubin, alkaline
phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse
reactions or reduced therapeutic effect due to drug interactions.
Certain strong CYP3A inhibitors may increase the plasma concentration of
ZEPATIER, leading to possibly clinically significant adverse reactions.
Moderate CYP3A inducers may decrease the plasma concentration of
ZEPATIER, leading to reduced therapeutic effect and possible development
of resistance. Coadministration of ZEPATIER with these drugs is not
recommended. Physicians should consult the Prescribing Information for
potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported
adverse reactions of all intensity (greater than or equal to 5% in
placebo-controlled trials) were fatigue, headache and nausea. In
subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly
reported adverse reactions of moderate or severe intensity (greater than
or equal to 5%) were anemia and headache.

Selected Dosage and Administration Information for ZEPATIER ®
(elbasvir and grazoprevir) 50 mg/100mg tablets

ZEPATIER is a single tablet taken once daily. The recommended dosing is
12 or 16 weeks with or without RBV, depending on HCV genotype, prior
treatment history and, for patients with genotype 1a infection, presence
of certain baseline NS5A resistance-associated polymorphisms. See
Prescribing Information for ZEPATIER for specific dosage regimens and
durations. Refer to RBV prescribing information for RBV dosing and
dosage modifications when ZEPATIER is given with RBV. To determine
dosage regimen and duration of ZEPATIER for genotype 1a patients,
testing for the presence of virus with one or more baseline NS5A
resistance-associated polymorphisms at positions 28, 30, 31, or 93 is
recommended prior to initiating treatment.

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 2016 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 ZEPATIER (elbasvir and
grazoprevir), including the Boxed Warning about the risk of HBV
reactivation in patients coinfected with HCV and HBV, at

http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf


and Patient Information for ZEPATIER at

http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf

Merck
Media:
Pam Eisele, 267-305-3558
Michael Close, 267-305-1211
or
Investors:
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898