Merck Initiates Phase II/III Study of Investigational BACE Inhibitor, MK-8931, for Treatment of Alzheimer's Disease

  Merck Initiates Phase II/III Study of Investigational BACE Inhibitor,
  MK-8931, for Treatment of Alzheimer's Disease

   Phased study to evaluate safety and efficacy of MK-8931 in patients with
                     mild-to-moderate Alzheimer's disease

Business Wire

WHITEHOUSE STATION, N.J. -- December 03, 2012

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced it has started a Phase II/III clinical trial designed to evaluate
the safety and efficacy of MK-8931 versus placebo in patients with
mild-to-moderate Alzheimer's disease. MK-8931 is Merck's novel investigational
oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, and is
the first with this mechanism to advance to this stage of clinical research.
The global, multi-center study, called EPOCH, is designed to initially
evaluate the safety of MK-8931 in a cohort of 200 patients prior to advancing
into a larger Phase III study.

"Merck is committed to advancing the understanding and treatment of
Alzheimer's disease," said Darryle D. Schoepp, Ph.D., senior vice president
and head of Neuroscience and Ophthalmology, Merck Research Laboratories. "As
the global health and financial burden of Alzheimer's disease grows,
innovative research is critically needed, and we need to accelerate this
research wherever possible. This new study is an important step in our overall
strategy to understand the potential of the BACE inhibitor mechanism and
MK-8931, our lead compound, in multiple stages of Alzheimer's disease."

About the EPOCH study

EPOCH is a 78-week, randomized, placebo-controlled, parallel-group,
double-blind Phase II/III clinical trial to evaluate the efficacy and safety
of one of three oral doses of MK-8931 (12, 40 or 60 mg) administered daily
versus placebo. The study is anticipated to eventually enroll up to 1,700
patients in the main Phase III cohort. 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)

For more information about the EPOCH study, please visit
or call 1-855-55-EPOCH (37624).

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 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 disease progression.

Earlier this year, Merck researchers presented findings of a multiple dose
Phase I study which demonstrated that MK-8931 can reduce cerebral spinal fluid
(CSF) β-amyloid by greater than 90 percent in healthy volunteers, without dose
limiting side effects.

Merck is advancing 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 BACE
inhibitor, MK-8931, and Merck is continuing to develop other BACE inhibitor

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 and
connect with us on Twitter, Facebook and YouTube.

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and Exchange Commission (SEC) available at the SEC’s Internet site


Caroline Lappetito, 908-423-3046
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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