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December 10, 2013 7:00 am ET

Data Monitoring Committee recommends continuation of Phase II/III EPOCH study in mild to moderate disease patients

Merck also plans to initiate dosing in Phase III study of prodromal disease patients

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today provided an update on the development program for MK-8931, a novel
investigational oral β-amyloid precursor protein site-cleaving enzyme
(BACE) inhibitor. The Data Monitoring Committee (DMC) for the Phase
II/III “EPOCH” study in patients with mild to moderate Alzheimer’s
disease recently completed its planned interim safety analysis and
recommended that the trial continue to recruit patients, with no changes
to the protocol.

The DMC recommendation was made following a planned analysis of interim
safety data that included a safety cohort of 200 patients treated with
MK-8931 for at least 3 months. Based upon the DMC’s recommendations,
Merck will continue enrollment of the EPOCH study. In addition, Merck
will initiate dosing in a new Phase III study (APECS study) evaluating
MK-8931 in patients with amnestic mild cognitive impairment due to
Alzheimer’s disease, also known as prodromal Alzheimer’s disease.

“We are pleased to receive the DMC’s recommendation and look forward to
continuing the clinical development program for MK-8931,” said Dr. David
Michelson, vice president, Neuroscience, Merck Research Laboratories.
“Studies to evaluate potential new treatment options are critical as the
global health and financial burden of Alzheimer’s disease grows.”

About the EPOCH Study

EPOCH
is a randomized, placebo-controlled, parallel-group, double-blind Phase
II/III clinical trial to evaluate the efficacy and safety of two oral
doses of MK-8931 (12 and 40 mg) administered daily versus placebo in
patients with mild to moderate Alzheimer’s disease. The Phase II portion
of the trial also included a 60 mg dose to evaluate safety. The trial is
anticipated to enroll up to 1,960 patients. The primary efficacy
outcomes of the study are the change from baseline in Alzheimer’s
Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the
change from baseline in the Alzheimer’s Disease Cooperative Study –
Activities of Daily Living (ADCS-ADL) score following 78 weeks of
treatment.

About the APECS Study

APECS
is a randomized, placebo-controlled, parallel-group, double-blind Phase
III clinical trial to evaluate the efficacy and safety of MK-8931 in
subjects with prodromal Alzheimer’s disease. The study is designed to
enroll 1500 participants. Patients will be randomized to receive
placebo, or 12 mg or 40 mg MK-8931, once daily. The primary efficacy
outcome of the study is change from baseline in the Clinical Dementia
Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of
treatment.

About BACE Inhibition and MK-8931

The amyloid hypothesis asserts that the formation of amyloid peptides
that lead to amyloid plaque deposits in the brain is a primary
contributor to the underlying cause of Alzheimer’s disease. BACE is
believed to be a key enzyme in the production of amyloid β peptide.
Evidence suggests that inhibiting BACE decreases the production of
amyloid β peptide and may therefore reduce amyloid plaque formation and
modify Alzheimer’s disease progression.

Merck’s Commitment to Patients Suffering from Alzheimer’s Disease

Merck is committed to advancing the understanding and treatment of
Alzheimer’s disease. We are currently evaluating several innovative
mechanisms in Alzheimer’s disease, including candidates designed to
modify disease progression and improve symptom control. Merck’s major
effort in disease modification is our lead investigational BACE
inhibitor, MK-8931, that is being evaluated in late stage clinical
trials for mild to moderate and prodromal Alzheimer’s disease. In
addition, Merck is conducting a Phase II clinical trial for MK-7622, an
investigational adjunctive therapy to donepezil for the symptomatic
treatment of participants with mild to moderate disease.

About Merck

Today’s Merck is a global healthcare 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
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,
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Merck 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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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’s 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 2012 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
Media:
Caroline Lappetito, 267-305-7639
Justine O’Malley, 908-423-2021
or
Investors:
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Justin Holko, 908-423-5088