Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that new Phase 2 data for its two investigational
hepatitis C virus (HCV) treatments - MK-5172, an investigational HCV
NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A
replication complex inhibitor – are scheduled to be presented at the 49th
Annual Meeting of the European Association for the Study of the Liver
(EASL), also known as The International Liver Congress™ 2014. The data
are from Merck’s overall Phase 2 clinical program. The meeting will take
place in London, United Kingdom, April 9 - 13, 2014.
Based on the results of the Phase 2 program, Merck is initiating a Phase
3 clinical trial program, to be named C-EDGE. The C-EDGE
program is designed to evaluate these investigational treatments across
genotypes and in different HCV subpopulations, including patients with
chronic kidney disease, HIV/HCV co-infection, and cirrhosis.
“These additional clinical data for MK-5172 and MK-8742 build upon the
clinical evidence collected to date across a broad spectrum of patients
with chronic HCV,” said Dr. Eliav Barr, vice president, Infectious
Disease, Merck Research Laboratories. “Based on these data, we are
pursuing a Phase 3 clinical program for these potentially important
investigational medicines.”
In October 2013, Merck announced that the U.S. Food and Drug
Administration granted Breakthrough Therapy designation to the
investigational combination MK-5172/MK-8742 for treatment of chronic HCV
infection.
Selected Presentations for MK-5172/MK-8742:
-
Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C
Genotype 1 Infected Patients with Cirrhosis or Previous Null-Response:
The C-WORTHY Study. Lawitz, E. et al. Oral presentation
#O61: April 11, 2014, 4:00-4:15 p.m. BST.
-
Efficacy and Safety of the All-Oral Regimen, MK-5172/MK-8742 ± RBV for
12 Weeks in GT1 HCV/HIV Co-infected Patients: The C-WORTHY
Study. Sulkowski, M. et al. Oral presentation #O63: April 11,
2014, 4:30-4:45 p.m. BST.
-
Safety and Efficacy of the All-Oral Regimen of MK-5172/MK-8742 ±
Ribavirin in Treatment-naïve, Non-cirrhotic Patients with Hepatitis C
Virus Genotype 1 Infection: The C-WORTHY Study. Hezode, C et
al. Oral Presentation #O10: April 10, 2014, 4:45-5:00 p.m. BST.
Merck’s Commitment to HCV
For more than 25 years, Merck has been at the forefront of the response
to the HCV epidemic, and has helped to make a difference through our
proud legacy of commitment to innovation, collaborating with the
community, and expanding global access to medicines. Merck is dedicated
to applying our scientific expertise, resources and global reach to
deliver healthcare solutions that support people living with HCV
worldwide.
About Merck
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside of 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 www.merck.com
and connect with us on Twitter,
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and YouTube.
Merck 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 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’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 2013 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).
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