Merck Provides Update on REVEAL Outcomes Study of Anacetrapib
June 27 2017 - 6:55AM
Business Wire
Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, today announced that the REVEAL (Randomized EValuation of
the Effects of Anacetrapib through Lipid modification) outcomes
study of anacetrapib met its primary endpoint, significantly
reducing major coronary events (defined as the composite of
coronary death, myocardial infarction, and coronary
revascularization) compared to placebo in patients at risk for
cardiac events who are already receiving an effective LDL-C
lowering regimen. The safety profile of anacetrapib in the early
analysis was generally consistent with that demonstrated in
previous studies of the drug, including accumulation of anacetrapib
in adipose tissue, as has been previously reported. Merck plans to
review the results of the trial with external experts, and will
consider whether to file new drug applications with the U.S. Food
and Drug Administration (FDA) and other regulatory agencies. The
results of the REVEAL study will be presented at the European
Society of Cardiology meeting on Aug. 29, 2017.
Anacetrapib is Merck’s investigational cholesteryl ester
transfer protein (CETP) inhibitor. The REVEAL study is a
randomized, double-blind placebo-controlled clinical trial to
assess the efficacy and safety of adding anacetrapib to effective
LDL-lowering treatment with atorvastatin for a median duration of
at least 4 years among approximately 30,000 patients at high risk
of cardiovascular events. REVEAL was designed and independently
conducted by investigators at the Clinical Trial Service Unit
(CTSU) at the University of Oxford, the trial’s regulatory sponsor,
in collaboration with the TIMI Study Group based at Brigham and
Women’s Hospital in Boston and Merck. Merck provided funding for
REVEAL. Details on the REVEAL study design are available at
clinicaltrials.gov:
https://clinicaltrials.gov/show/NCT01252953.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
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. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us
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and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
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 2016
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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MerckMedia:Pamela Eisele, 267-305-3558orKate Prout,
267-305-1971orInvestors:Amy Klug, 908-740-1898
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