Merck Announces Pivotal Phase 3 Study of Letermovir, an Investigational Antiviral Medicine for Prevention of Cytomegalovirus ...
October 19 2016 - 7:00AM
Business Wire
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the
United States and Canada, today announced that the pivotal Phase 3
clinical study of letermovir, an investigational antiviral
medicine, met its primary endpoint. The global, multicenter,
randomized, placebo-controlled study evaluated the efficacy and
safety of letermovir for the prevention of clinically-significant
cytomegalovirus (CMV) infection in adult (18 years and older)
CMV-seropositive recipients of an allogeneic hematopoietic stem
cell transplant (HSCT). Merck will submit results from the study
for presentation at a future scientific conference.
“There is an unmet need for therapeutic options in the
prevention of CMV infection in high-risk allogeneic hematopoietic
stem cell transplant recipients,” said Dr. Roy Baynes, senior vice
president of clinical development, Merck Research Laboratories.
“Merck is pleased this pivotal Phase 3 study with letermovir met
its primary endpoint. We thank the patients and families who
participated in this study and we look forward to presenting
results at a future scientific meeting.”
In the study, letermovir was administered once daily, either in
oral tablet or IV formulation. Letermovir was started as early as
the day of HSCT transplant and no later than 28 days
post-transplant, and continued through approximately 100 days after
transplant. The primary outcome measure was the percentage of
participants with clinically-significant CMV infection through 24
weeks after transplant. Additional details about the study can be
found online at www.clinicaltrials.gov/ct2/show/NCT02137772.
About letermovir
Letermovir is an investigational once-daily antiviral medicine
under development for the prevention of CMV infection and disease.
It is a member of a new class of non-nucleoside CMV inhibitors (3,4
dihydro-quinazolines) and inhibits viral replication by targeting
the viral terminase complex. Letermovir has been granted orphan
designation by the European Medicines Agency, the U.S. Food and
Drug Administration (FDA) and the Japanese Ministry of Health,
Labour and Welfare for the prevention of CMV infection and disease
in at-risk populations. Letermovir also has been granted Fast Track
designation by the FDA.
Under an agreement signed in 2012, Merck (through a subsidiary)
purchased worldwide rights to develop and commercialize letermovir
from AiCuris GmbH & Co KG (www.aicuris.com).
About Merck
For 125 years, Merck has been 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
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 2015
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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version on businesswire.com: http://www.businesswire.com/news/home/20161019005123/en/
MerckMedia:Pam Eisele, 267-305-3558Robert Consalvo,
908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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