Merck to Present New Findings from Chronic Hepatitis C Clinical Development Programs at The International Liver CongressTM 2016

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March 30, 2016 6:00 am ET

Presentations Include Results from Phase 3 Study Evaluating ZEPATIER™ (elbasvir and grazoprevir) Compared to Sofosbuvir-Containing Regimen, and Results from Studies in Difficult-to-Treat Populations

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced the planned presentations of data from the company’s
broad chronic hepatitis C virus (HCV) clinical development programs at
the upcoming International
Liver Congress™ 2016. Clinical data from trials evaluating ZEPATIER™
(elbasvir and grazoprevir) 50mg/100mg tablets will be featured,
including the Phase 3 C-EDGE
Head-to-Head trial comparing ZEPATIER to a regimen of sofosbuvir
with peginterferon alfa and ribavirin (RBV), and the Phase 3 C-EDGE
IBLD and C-EDGE
CO-STAR studies evaluating ZEPATIER in underserved patients with
historically difficult-to-treat conditions. In addition, data from
trials evaluating Merck’s chronic HCV candidates MK-3682B
(grazoprevir/MK-8408¹/MK-3682²) and MK-8408
monotherapy will be presented. ZEPATIER – Merck’s once-daily, fixed-dose
combination tablet indicated with or without RBV for the treatment of
chronic HCV genotype (GT) 1 or GT4 infection in adults – was approved by
the U.S. Food and Drug Administration (FDA) on Jan. 28, 2016. The
International Liver Congress™ 2016 is scheduled to take place at the
Fira Barcelona Gran Via, Barcelona, Spain from April 13-17, 2016.

“We continue to build on the data that supported the recent U.S. FDA
approval of ZEPATIER with additional studies that provide clinical
evidence about ZEPATIER in multiple patient populations,” said Dr. Eliav
Barr, vice president, infectious diseases, Merck Research Laboratories.
“Merck remains committed to the fight against chronic hepatitis C
through our ongoing clinical programs exploring diverse patient groups
and areas of unmet need.”

At The International Liver Congress™ 2016, key data presentations will
include:

New data from the Phase 3 C-EDGE clinical trial program,
evaluating ZEPATIER (elbasvir and grazoprevir) (with or without RBV),
across multiple HCV genotypes (1, 4 and 6) and diverse patient
populations, including those who are historically difficult-to-treat,
over a 12-week treatment duration.

Thursday, April 14:

C-EDGE
Head-to-Head (H2H): Efficacy and Safety of Elbasvir and
Grazoprevir Compared With Sofosbuvir/Pegylated Interferon/Ribavirin: A
Phase 3 Randomized Controlled Trial (Oral presentation, Abstract
#PS002, 4:15 p.m.-4:30 p.m. CEST)

C-EDGE
CO-STAR: Favorable Impact of Elbasvir and Grazoprevir
on Health-Related Quality of Life in Treatment-Naïve HCV-Infected
Persons Who Inject Drugs Receiving Opioid Agonist Therapy (Poster
presentation, Abstract #THU-225, 8:00 a.m.-6:00 p.m. CEST)

Saturday, April 16:

C-EDGE
IBLD: Efficacy and Safety of Elbasvir/Grazoprevir (EBR/GZR) in
Subjects With Chronic Hepatitis C Virus Infection and Inherited Blood
Disorders (IBLD) (Poster presentation, Abstract #SAT-128, 8:00
a.m.-6:00 p.m. CEST)
C-EDGE
TN: Final SVR24 Data From the Phase 3 C-EDGE Treatment-Naïve
(TN) Study of Elbasvir (EBR)/Grazoprevir (GZR) in Patients With
Chronic HCV Genotype 1, 4 or 6 Infection (Poster presentation,
Abstract #SAT-266, 8:00 a.m.-6:00 p.m. CEST)
C-EDGE
CO-STAR: Risk of Reinfection Following Successful
Therapy With Elbasvir and Grazoprevir in Persons Who Inject Drugs
(PWID) Receiving Opioid Agonist Therapy (OAT) (Poster presentation,
Abstract #SAT-163, 8:00 a.m.-6:00 p.m. CEST)

Additional Presentations of Interest

Thursday, April 14:

In a 5-Day Monotherapy Trial, MK-8408 Demonstrates Potent Antiviral
Activity and Improved Resistance Profile in HCV Patients With
Genotypes 1, 2, and 3 Infections (Poster presentation, Abstract
#THU-222, 8:00 a.m.-6:00 p.m. CEST)

Saturday, April 16:

High Efficacy of an 8-Week 3-Drug Regimen of
Grazoprevir/MK-8408/MK-3682 in HCV Genotype 1, 2 and 3-Infected
Patients: SVR24 Data From the Phase 2 C-CREST
1 and 2
Studies (Poster presentation, Abstract #SAT-139, 8:00 a.m.-6:00 p.m.
CEST)
C-SWIFT
Retreatment Final Results: Highly Successful Retreatment of
GT1-Infected Patients With 12 Weeks of Elbasvir/Grazoprevir Plus
Sofosbuvir and Ribavirin After Failure of Short-Duration All-Oral
Therapy (Poster presentation, Abstract #SAT-148, 8:00 a.m.-6:00 p.m.
CEST)
Cost Effectiveness of Elbasvir (EBS, MK-8742)/Grazoprevir
(GZR/MK-5172) Use in Treatment-Naïve and Treatment-Experienced
Patients With Hepatitis C Virus (HCV) Genotype 1 Infection and Chronic
Kidney Disease (CKD) in the United States (Poster presentation,
Abstract #SAT-141, 8:00 a.m.-6:00 p.m. CEST)
Sustained Virologic Response Among Patients With Genotype 1 Hepatitis
C and Treated With Interferon-Free Direct-Acting Antiviral Regimens
(Poster presentation, Abstract #SAT-217, 8:00 a.m.-6:00 p.m. CEST)
Characteristics and Prevalence of Chronic Kidney Disease Among
Patients With Hepatitis C Who Are Treated With Interferon-Free
Direct-Acting Antiviral Regimens (Poster presentation, Abstract
#SAT-109, 8:00 a.m.-6:00 p.m. CEST)

For more information, including a complete list of abstract titles at
the meeting, please visit: http://ilc-congress.eu/.

Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)

ZEPATIER is not for use in patients with moderate or severe hepatic
impairment (Child Pugh B or C). ZEPATIER is also not for use with
organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors
(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 ribavirin
(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 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 possible
clinically significant adverse reactions from greater exposure to
ZEPATIER or concomitant drugs. Coadministration of ZEPATIER is not
recommended with certain strong CYP3A inhibitors (e.g., ketoconazole or
the cobicistat-containing regimens of
elvitegravir/cobicistat/emtricitabine/tenofovir [disoproxil fumarate or
alafenamide]). Healthcare professionals should not exceed atorvastatin
20mg/daily or rosuvastatin 10mg/daily when given with ZEPATIER. If
ZEPATIER is given with fluvastatin, lovastatin or simvastatin,
healthcare professionals should give the lowest statin dose necessary
and closely monitor for statin-associated adverse events. If ZEPATIER
and tacrolimus are coadministered, frequent monitoring of tacrolimus
whole blood concentrations, changes in renal function and
tacrolimus-associated adverse events is recommended.

The concomitant use of ZEPATIER and certain drugs may cause significant
decrease of elbasvir and grazoprevir plasma concentrations, which may
lead to reduced therapeutic effect of ZEPATIER and possible development
of resistance. Coadministration of ZEPATIER is not recommended with
moderate CYP3A inducers (e.g., nafcillin, bosentan, etravirine,
modafinil).

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.

About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a
hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A
protease inhibitor, and is indicated with or without ribavirin (RBV) for
treatment of chronic HCV genotype (GT) 1 or GT4 infection in adults. The
dosing regimens and durations for treatment with once-daily ZEPATIER for
chronic HCV GT1 or GT4 infection in patients with or without cirrhosis,
HIV-1 co-infection or renal impairment are as follows:

Twelve weeks of treatment with ZEPATIER is recommended for:
GT1a-infected patients who are treatment-naïve or who failed prior
treatment with peginterferon alfa plus RBV (PegIFN/RBV-experienced)
without baseline NS5A resistance-associated polymorphisms (amino acid
positions 28, 30, 31 or 93); GT1b-infected patients who are
treatment-naïve or PegIFN/RBV-experienced; and GT4-infected patients
who are treatment-naïve.
Twelve weeks of treatment with ZEPATIER in combination with RBV is
recommended for GT1a- or GT1b-infected patients who failed prior
treatment with PegIFN/RBV + a HCV NS3/4A protease inhibitor (PI)
(boceprevir, simeprevir or telaprevir). For GT1a-infected
PegIFN/RBV/PI-experienced patients with one or more baseline NS5A
resistance-associated polymorphisms, the optimal ZEPATIER-based
treatment regimen and duration of therapy has not been established.
Sixteen weeks of treatment with ZEPATIER in combination with RBV is
recommended for: GT1a-infected patients who are treatment-naïve or
PegIFN/RBV-experienced with baseline NS5A resistance-associated
polymorphisms;and GT4-infected patients who are
PegIFN/RBV-experienced.

For patients with chronic HCV GT1a infection, testing for the presence
of NS5A resistance-associated polymorphisms is recommended prior to
starting treatment with ZEPATIER to determine the optimal dosage regimen
and duration.

Merck’s Commitment to HCV

For nearly 30 years, Merck has been at the forefront of the response to
the HCV epidemic. Merck employees are dedicated to applying their
scientific expertise, resources and global reach to develop and deliver
innovative healthcare solutions to support people living with chronic
HCV worldwide.

About Merck

For 125 years, Merck has been a global health care 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
health care through far-reaching policies, programs and partnerships.
For more information, visit www.merck.com
and connect with us on Twitter,
Facebook,
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 2015 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) at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf
and the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf.

_____________

¹ MK-8408 is an HCV NS5A inhibitor

² MK-3682 is an HCV nucleotide analogue NS5B polymerase
inhibitor