Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742, an Investigational Oral Combination Regimen for the Treatment of Chronic Hepatitis C Virus (HCV) Infection


October 22, 2013 4:00 pm ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
granted MK-5172/MK-8742 Breakthrough Therapy designation for treatment
of chronic hepatitis C virus infection. MK-5172/MK-8742 is an all-oral
combination regimen consisting of MK-5172, an investigational HCV NS3/4A
protease inhibitor, and MK-8742, an investigational HCV NS5A replication
complex inhibitor. Interim data from an ongoing Phase IIB clinical trial
evaluating MK-5172/MK-8742 in genotype 1 infected patients (C-WORTHY
Study) is scheduled to be presented at the 64th
American Association for the Study of Liver Disease Annual Meeting,

Washington D.C., Nov. 1-5.

“The designation of MK-5172/MK-8742 as a Breakthrough Therapy for
chronic hepatitis C is an important milestone for Merck,” said Dr. Roger
M. Perlmutter, president, Merck Research Laboratories. “There remains
significant unmet medical need in hepatitis C, and we are looking
forward to working with the FDA to advance this program as quickly as we
can to bring this investigational combination to HCV specialists and
their patients.”

According to the FDA, the designation of an investigational drug as a
Breakthrough Therapy 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.

Chronic hepatitis C is a priority focus of research and development at
Merck. MK-5172 and MK-8742 are being investigated in a broad clinical
program that includes studies in patients with multiple HCV genotypes
who are treatment-naïve, treatment failures as well as other important
HCV subpopulations such as patients with cirrhosis and those co-infected
with HIV. For more information please see

About Merck

Today’s Merck is a global healthcare 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
consumer care 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
healthcare through far-reaching policies, programs and partnerships. For
more information, visit
and connect with us on Twitter,
and YouTube.

Forward-Looking Statement

This news release 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 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 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’s 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. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2012 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 (

Media Contacts:
Pamela Eisele, 908-423-5042
Sarra Herzog, 908-423-6154
Investor Contacts:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

Unsubscribe from email alerts