Merck Initiates Phase 3 Study of Letermovir, an Investigational Antiviral for Prevention of Cytomegalovirus (CMV) Infection i...
July 24 2014 - 8:30AM
Business Wire
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the first patient has been enrolled in
a global Phase 3 clinical study of letermovir (MK-8228), an
investigational antiviral agent. The multicenter, randomized,
placebo-controlled study will evaluate 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 allogeneic hematopoietic stem cell
transplants.
“There remains a need for additional therapeutic options in the
prevention of CMV infection in high-risk patients,” said Dr.
Michele Trucksis, executive director, Infectious Diseases, Merck
Research Laboratories. “Merck is pleased to initiate this global
Phase 3 study with letermovir.”
“This study marks a very important step in the development of
letermovir and for AiCuris as licensor of this compound,” said
Prof. Helga Rübsamen-Schaeff, CEO of AiCuris. “We are very excited
to have reached this stage and look forward to the results.”
In the study, letermovir will be administered once daily, either
as an oral tablet or IV formulation, for 14 weeks after transplant.
The dose will be 240 mg once daily for participants receiving
concomitant cyclosporin A and 480 mg once daily for participants
not receiving cyclosporin A. The primary outcome measure of the
study will be the percentage of participants with
clinically-significant CMV infection through 24 weeks after
transplant who were administered letermovir compared to
placebo.
Merck expects approximately 540 patients will be enrolled in the
study at more than 70 centers in 20 countries, including the United
States. The estimated study completion date is July 2017.
To learn more about the study, please contact Merck at
1-888-577-8839 or visit www.merck.com/clinical-trials. Additional
details can also be found online at
www.clinicaltrials.gov/ct2/show/NCT02137772.
About letermovir
Letermovir is an investigational once-daily antiviral agent
under development for the prevention of human CMV infection. It is
derived from a novel chemical class (quinazolines) and is designed
to inhibit the human CMV viral terminase. Letermovir has been
granted Orphan Product Designation by the European Medicines Agency
(EMA) and the U.S. Food and Drug Administration (FDA) for the
prevention of CMV viremia and disease in at-risk populations and
also has been granted Fast Track Status 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 CMV
CMV is widely spread in the human population and can cause
severe, life-threatening infections in cases of immune incompetency
or immune deficiency, such as, for example, in transplant
recipients. CMV infection is characterized by fever, leukopenia
(very low white blood cell count) and thrombocytopenia (very low
platelet numbers) with or without specific organ dysfunction. Two
main strategies to prevent CMV infection in transplant recipients
at risk have been adopted: anti-CMV drug prophylaxis or
surveillance and pre-emptive treatment of transplant recipients
with evidence of CMV viremia.
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, Facebook 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 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. 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).
MerckMedia:Pam Eisele, 267-305-3558orRobert Consalvo,
908-423-6595orInvestor:Joseph Romanelli, 908-423-5185orJustin
Holko, 908-423-5088
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