Merck Announces Pivotal Phase 3 Study of Letermovir Met Primary Endpoint

- October 19th, 2016

Merck & Co. today announced that the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine, met its primary endpoint.

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
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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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