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August 29, 2017 1:31 am ET

Results Published in The New England Journal of Medicine and Presented at the European Society of Cardiology Congress

Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, and
researchers in the Clinical Trial Service Unit at the University of
Oxford, today announced the publication and presentation of results from
the REVEAL (Randomized EValuation of the Effects of Anacetrapib through
Lipid modification) outcomes study of anacetrapib, Merck’s
investigational cholesteryl ester transfer protein (CETP) inhibitor. In
the study of 30,449 patients with atherosclerotic vascular disease
receiving LDL-C lowering treatment with atorvastatin, anacetrapib
significantly reduced the risk of major coronary events (composite of
coronary death, myocardial infarction or coronary revascularization) by
9 percent relative to placebo (10.8% vs. 11.8%, respectively; P=0.004).
The safety of anacetrapib was generally consistent with data from
earlier trials of the drug. However, a sub-study also showed that
anacetrapib accumulates in adipose tissue with prolonged dosing. Merck
is reviewing 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 REVEAL were presented today by Dr. Martin Landray of the
University of Oxford, the trial’s co-principal investigator, during a
late-breaking clinical trials session at the European Society of
Cardiology Congress, and simultaneously published in the online edition
of The New England Journal of Medicine. REVEAL was designed and
independently conducted by investigators at the Clinical Trial Service
Unit 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.

“Despite treatment advances in recent years, patients with
cardiovascular disease remain at risk for cardiovascular events. We are
pleased that adding anacetrapib to statin therapy resulted in a further
reduction of major coronary events in REVEAL,” said Dr. Roy Baynes,
senior vice president, head of clinical development, and chief medical
officer, Merck Research Laboratories. “This trial helps to advance our
understanding of the effects of anacetrapib on cardiovascular risk, and
we are grateful to the study leaders at Oxford, TIMI, the many
investigators, and the thousands of patients who participated in this
study for their efforts.”

In the randomized, double-blind, placebo-controlled study, 30,449 adults
with atherosclerotic vascular disease on study-mandated intensive
atorvastatin therapy (mean baseline LDL cholesterol level 61 mg/dL [1.58
mmol/L], non-HDL cholesterol 92 mg/dL [2.38 mmol/L], and HDL cholesterol
40 mg/dL [1.03 mg/dL]) were randomly assigned to receive either
anacetrapib 100 mg once daily or matching placebo. The primary
assessment was an intention-to-treat comparison among all randomized
participants of the effect of anacetrapib on the composite of major
coronary events, defined as the first occurrence of coronary death,
myocardial infarction, or coronary revascularization.

Compared with placebo, the addition of anacetrapib further reduced the
mean level of non-HDL cholesterol by 17 mg/dL (0.44 mmol/L,18%) and
increased HDL cholesterol level by 43 mg/dL (1.12 mmol/L, 104%) at the
study midpoint. During median follow-up of 4.1 years, a 9 percent
relative reduction in the risk major coronary events was observed among
those receiving anacetrapib compared to placebo (1640 events [10.8%] vs.
1803 events [11.8%]; rate ratio 0.91; 95% CI 0.85 to 0.97; P=0.004). The
benefit was similar across multiple pre-specified subgroups.

The difference in the key secondary composite outcome of major
atherosclerotic events (myocardial infarction, coronary death or
presumed ischemic stroke) did not reach statistical significance (rate
ratio, 0.93; 95% CI, 0.86 to 1.00; P=0.052), possibly due to a lack of
observed benefit of anacetrapib on presumed ischemic stroke. There were
no statistically significant differences in cause-specific mortality,
cancer, or other serious adverse events. Anacetrapib produced small
increases in systolic and diastolic blood pressures of 0.7 mmHg and 0.3
mmHg, respectively; there was no statistically significant increase of
serious adverse events attributed to hypertension. Compared to those
receiving placebo, more patients in the anacetrapib group developed an
estimated glomerular filtration rate of less than 60 ml/min/1.73m²
by the end of the study (11.5% vs. 10.6%; P=0.04); there was no
statistically significant impact on the development of albuminuria or
serious adverse events attributed to renal failure.

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
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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
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including obtaining regulatory approval; the company’s ability to
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or delays; financial instability of international economies and
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and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

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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).

Merck
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