Merck Advances Development Program for Investigational Alzheimer’s Disease Therapy, MK-8931

  Merck Advances Development Program for Investigational Alzheimer’s Disease
  Therapy, MK-8931

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

Business Wire

WHITEHOUSE STATION, N.J. -- December 10, 2013

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, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of
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Additional factors that could cause results to differ materially from those
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Contact:

Merck
Media:
Caroline Lappetito, 267-305-7639
Justine O’Malley, 908-423-2021
or
Investors:
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Justin Holko, 908-423-5088
 
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