Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection


July 28, 2015 5:30 am ET

Company Granted FDA Priority Review with Target Action Date of January 28, 2016

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the New Drug Application for grazoprevir/elbasvir
(100mg/50mg), an investigational, once-daily, single-tablet combination
therapy for the treatment of adult patients infected with chronic
hepatitis C virus (HCV) genotypes (GT) 1, 4 or 6.1 The FDA
granted Priority Review for grazoprevir/elbasvir (100mg/50mg), with a
Prescription Drug User Fee Act (PDUFA) action date of January 28, 2016.

“The U.S. FDA’s Priority Review designation for grazoprevir/elbasvir
underscores how innovative treatment approaches for chronic hepatitis C
are still needed for many patient populations,” said Dr. Roy Baynes,
senior vice president of clinical development, Merck Research
Laboratories. “Our clinical data for grazoprevir/elbasvir in broad and
diverse patient populations with chronic hepatitis C are very
encouraging, and we look forward to continuing our dialogue with the FDA
to bring this novel combination medicine to the appropriate patients
with chronic hepatitis C.”

The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based
in part upon data from the pivotal C-EDGE clinical trials
program, as well as the C-SURFER and C-SALVAGE trials.
from these trials
were previously presented at The International
Liver Conference 2015™. Collectively, these trials evaluated treatment
regimens of grazoprevir/elbasvir (100mg/50mg), with or without
ribavirin, in multiple genotypes (GT1, 4 and 6) including patient
populations who were previously treated, and those with cirrhosis or
certain co-morbidities (e.g., HIV/HCV co-infection, chronic kidney
disease stages 4 and 5).

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is Merck’s investigational, once-daily,
single-tablet combination therapy consisting of grazoprevir (NS3/4A
protease inhibitor) and elbasvir (NS5A replication complex inhibitor).
As part of Merck’s broad clinical trials program, grazoprevir/elbasvir
is being evaluated in multiple HCV genotypes including patients with
difficult-to-treat conditions such as HIV/HCV co-infection, advanced
chronic kidney disease, inherited blood disorders, liver cirrhosis and
those on opiate substitution therapy.

In April 2015, the FDA granted Breakthrough Therapy designation status
for grazoprevir/elbasvir for the treatment of patients infected with
chronic HCV GT1 with end stage renal disease on hemodialysis, and
Breakthrough Therapy designation status for grazoprevir/elbasvir for the
treatment of patients infected with chronic HCV GT4. Breakthrough
Therapy designation is intended to expedite the development and review
of a candidate that is planned for use, alone or in combination, to
treat a serious or life-threatening disease or condition when
preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on one or more
clinically significant endpoints.

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,
and connect with us on Twitter,
and YouTube.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the
“company”) 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 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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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 (

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

Doris Li, (908) 246-5701
Sarra Herzog, (201) 669-6570
Joe Romanelli, (908) 740-1986
Justin Holko, (908) 740-1879

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