Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection


May 28, 2015 3:30 pm ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the company has submitted a New Drug Application to
the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir
(100mg/50mg), an investigational once-daily, single tablet combination
therapy for the treatment of adult patients with chronic hepatitis C
genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the
FDA will determine whether it will accept for review Merck’s application
as filed. The company plans to submit additional license applications in
the European Union and other markets by the end of 2015.

“Merck’s submission is based on evidence from our wide-ranging clinical
program assessing the efficacy and tolerability profile of
grazoprevir/elbasvir in populations with chronic hepatitis C,” said Dr.
Roy Baynes, senior vice president of clinical development, Merck
Research Laboratories. “This submission to the U.S. FDA is an important
milestone as we seek to provide patients with a new treatment option for
this serious infection.”

The FDA has previously 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 for
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.

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,
evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin,
in patients with chronic hepatitis C infection. Data from these trials
were presented at The
International Liver CongressTM 2015
in April 2015.

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is an investigational, once-daily single tablet
regimen 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 studied in
multiple HCV genotypes and in 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.

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,
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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 (

Doris Li, 908-246-5701
Sarra Herzog, 908-740-1871
Joe Romanelli, 908-740-1986
Justin Holko, 908-740-1879

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