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November 16, 2015 8:30 am ET

Merck Advances to Part B of C-CREST Phase 2 Clinical Development Program

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the presentation of results from the initial phase (Part
A) of the company’s C-CREST 1 and 2 Phase 2
clinical development program evaluating two investigational all-oral,
triple-combination treatment regimens – a regimen of grazoprevir¹,
MK-3682² and elbasvir³; and a regimen
of grazoprevir, MK-3682 and MK-8408⁴ – in treatment-naïve
patients with chronic hepatitis C virus (HCV) genotypes (GT) 1, 2 or 3
infection. These data will be presented today during a late-breaking
abstract session at The
Liver Meeting^® (Abstract #LB-15). Based on the results of
this initial trial, Merck has initiated further study of grazoprevir
(100mg), MK-3682 (450mg) and MK-8408 (60mg) in the second phase (Part B)
of the C-CREST Phase 2 clinical development program.

“Merck’s chronic hepatitis C development program continues to focus on
the goal of advancing a short-duration treatment regimen that offers
high virologic cure rates across all viral genotypes,” said Dr. Roy
Baynes, senior vice president and head of global clinical development,
Merck Research Laboratories. “The strong results observed in this study
support the further investigation of the novel triple-combination
regimen of grazoprevir, MK-3682 and MK-8408 in patients with chronic
hepatitis C.”

In these randomized, open-label clinical trials, C-CREST
1 evaluated treatment-naive, non-cirrhotic patients with chronic
HCV GT1 or 2 infection and C-CREST
2 evaluated treatment-naive, non-cirrhotic patients with chronic
HCV GT3 infection. The primary efficacy endpoint was sustained virologic
response 12 weeks after the completion of treatment (SVR12, or virologic
cure). All 240 enrolled patients completed eight weeks of treatment and
reached follow-up 12 weeks after end of treatment. Treatment with
grazoprevir (100mg), MK-3682 (450mg) and MK-8408 (60mg), without
ribavirin (RBV), for eight weeks resulted in virologic cure rates of
greater than 90 percent across chronic HCV patients with GT1, 2 or 3
infection, which supported the decision to advance this regimen into
Part B of the C-CREST Phase 2 clinical trial program.

The most commonly reported adverse events across all regimens (greater
than 10% incidence) were headache (23%), fatigue (20%) and nausea (13%).
There were no drug-related serious adverse events and no
discontinuations due to adverse events.

About the C-CREST Program

The C-CREST Phase 2 clinical development program is designed to
evaluate the safety and efficacy of Merck’s triple-combination treatment
regimens in patients with chronic HCV GT1, 2 or 3 infection. The
investigational medicines studied in the initial phase (Part A) of the C-CREST
program included:

• Grazoprevir (MK-5172), an HCV NS3/4A protease inhibitor
• MK-3682, an oral prodrug HCV nucleotide analogue NS5B polymerase
  inhibitor
• Elbasvir (MK-8742), an HCV NS5A replication complex inhibitor
• MK-8408, an HCV NS5A replication complex inhibitor

Based on the results from the initial phase (Part A) in treatment-naive,
non-cirrhotic chronic HCV patients, Merck has initiated further study of
grazoprevir, MK-3682 and MK-8408 in the second phase (Part B) of the C-CREST
Phase 2 program. Part B will evaluate the safety and efficacy of this
regimen with or without RBV in chronic HCV patients with GT1, 2 or 3
infection for different treatment durations. The various study arms will
include treatment-naive patients with or without compensated cirrhosis
or with HIV/HCV co-infection, as well as treatment-experienced patients
(previously treated with pegylated interferon/RBV) with GT3 infection.

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
healthcare 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,
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 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).

Merck
Media:
Doris Li, 908-246-5701
Sarra Herzog, 201-669-6570
or
Investors:
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898