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April 23, 2015 12:00 am ET

Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection

Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the first presentations of data from the company’s
ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating
the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg)
in patients with or without cirrhosis who are infected with chronic
hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).¹
Patients in both the HCV infected, treatment-naïve (C-EDGE TN),
and HIV/HCV co-infected, treatment-naïve (C-EDGE CO-INFXN) trials
treated for 12 weeks achieved rates of sustained virologic response 12
weeks after the completion of treatment (SVR12) of 95 percent (299/316
and 207/218, respectively). In addition, HCV infected,
treatment-experienced patients (C-EDGE TE) treated with or
without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent
(98/104) and 92 percent (97/105), respectively, and those treated for 16
weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent
(97/105), respectively. These data were presented at The
International Liver Congress^TM 2015 – the 50^th
annual congress of the European Association for the Study of the Liver
(Abstract #G07, E-Poster P0886 and E-Poster P0887). A paper detailing
the findings of C-EDGE TN was published online in the Annals
of Internal Medicine today.

“Patients with co-morbidities and varying treatment experiences
represent important segments of the chronic hepatitis C population in
need of additional innovative treatment options,” said Dr. Eric Lawitz,
vice president, scientific and research development, The Texas Liver
Institute and clinical professor of medicine, The University of Texas
Health Science Center, San Antonio. “These findings are important
because they demonstrate that a single pill of grazoprevir/elbasvir
taken once-daily achieved consistently high rates of SVR12 in the
patient populations studied.”

“At Merck, we continue to build upon our clinical experience using
grazoprevir/elbasvir across diverse populations of patients infected
with chronic hepatitis C virus,” said Dr. Eliav Barr, vice president,
infectious diseases, Merck Research Laboratories. “We remain on track to
submit a New Drug Application with the U.S. Food and Drug Administration
in the first half of 2015.”

C-EDGE TN Overview and Additional Findings

C-EDGE
TN is a randomized, blinded, placebo-controlled trial evaluating
the efficacy and safety of grazoprevir/elbasvir in treatment-naïve
patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6
who received therapy for 12 weeks. Patients were randomized to an
immediate treatment group that received grazoprevir/elbasvir for 12
weeks or to a deferred treatment group that received placebo for 12
weeks, were followed for an additional four weeks, and then received
open label grazoprevir/elbasvir for the next 12 weeks. The primary
efficacy analysis included those patients who received immediate
treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who
received immediate treatment with grazoprevir/elbasvir, 50 percent were
infected with GT1a, 42 percent with GT1b, six percent with GT4 and three
percent with GT6. Overall, 22 percent of patients had liver cirrhosis.

In this study, virologic failure occurred in 13 patients (4%) in the
immediate treatment group, including one virologic breakthrough and 12
virologic relapses. Serious adverse events occurred in nine (3%) and
three (3%) patients in the immediate treatment and corresponding placebo
arms, respectively; none were considered drug-related. The most common
adverse events reported (greater than 5% incidence) in the immediate
treatment and corresponding placebo groups, were headache (17%, 18%),
fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%),
respectively.

C-EDGE CO-INFXN Overview and Additional Findings

C-EDGE
CO-INFXN is an open label, single-arm study evaluating the
efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients
with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV
who received therapy for 12 weeks. Of the 218 patients enrolled in the
trial, 66 percent were infected with HCV GT1a, 21 percent with GT1b or
other GT1, 13 percent with GT4, and one percent with GT6. Overall, 16
percent of patients had liver cirrhosis.

In this study, virologic failure occurred in seven patients (3%),
including six virologic relapses and one reinfection. There were no
reported drug-related serious adverse events. The most common (greater
than 5% incidence) adverse events reported were fatigue (13%), headache
(12%) and nausea (9%).

C-EDGE TE Overview and Additional Findings

C-EDGE
TE is a randomized study evaluating the efficacy and safety of
once-daily grazoprevir/elbasvir with or without twice-daily RBV in
treatment-experienced (prior null response, partial response or relapse
with peg-interferon/RBV) patients with or without cirrhosis infected
with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16
weeks.

12 week arms

Of the 209 patients randomized to the 12 week arms, 105 patients
received grazoprevir/elbasvir only and 104 patients
received grazoprevir/elbasvir plus RBV. Patients in the
grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33 percent GT1b
or other GT1 and nine percent GT4. Overall, 35 percent had liver
cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus
RBV, 58 percent were infected with chronic HCV GT1a, 28 percent GT1b or
other GT1, and 14 percent GT4. Overall, 34 percent had liver cirrhosis.

In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms,
six patients in each arm (6%) were reported to have virologic relapse.
No patients were reported to have virologic breakthrough or rebound.
Serious adverse events were reported in four patients in the
grazoprevir/elbasvir only arm (4%) and three patients in the
grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than
10% incidence) adverse events reported in the grazoprevir/elbasvir and
grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%,
27%), headache (21%, 20%) and nausea (9%, 14%).

16 week arms

Of the 211 patients enrolled in the 16 week arms, 105 patients received
grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir
plus RBV. In the grazoprevir/elbasvir only arm, 46 percent were infected
with chronic HCV GT1a, 46 percent with GT1b or other GT1, five percent
with GT4 and four percent with GT6. Overall, 36 percent of patients had
liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm,
55 percent were infected with chronic HCV GT1a, 36 percent with GT1b or
other GT1, eight percent with GT4, and two percent with GT6. Overall, 35
percent had liver cirrhosis.

Among the patients receiving grazoprevir/elbasvir only, three patients
(3%) were reported to have virologic breakthrough or rebound and four
patients (4%) were reported to have virologic relapse. No virologic
failures occurred in patients receiving grazoprevir/elbasvir plus RBV.
Serious adverse events were reported in three patients in the
grazoprevir/elbasvir only arm (3%) and four patients in the
grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than
10% incidence) adverse events reported in the grazoprevir/elbasvir and
grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%,
30%), headache (19%, 19%) and nausea (4%,17%).

About the C-EDGE Program

C-EDGE is the Phase 3 clinical development program for Merck’s
investigational HCV treatment grazoprevir/elbasvir comprising five
studies with more than 1,700 patients across more than 25 countries.
These studies are evaluating grazoprevir/elbasvir in multiple genotypes
(GT1, 4 and 6) and diverse patient populations, including
difficult-to-treat patients such as: treatment-experienced, patients
with cirrhosis, HIV/HCV co-infection, advanced chronic kidney disease,
inherited blood disorders, and those receiving opiate substitution
therapies.

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 deliver innovative
health care solutions that support people living with HCV worldwide.

About Merck

Today’s Merck is 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,
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and YouTube.

Forward-Looking Statement

This news release 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 Merck’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; 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 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 except as required by applicable law. Additional factors that
could cause results to differ materially from those described in the
forward-looking statements can be found in Merck’s 2014 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).

¹ Grazoprevir is an HCV NS3/4A protease inhibitor and
elbasvir is an HCV NS5A replication complex inhibitor

Merck
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Doris Li , 908-246-5701
or
Sarra Herzog, 201-669-6570
or
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or
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