Merck and GE Healthcare Collaborate on Use of Imaging Biomarkers for Investigational BACE inhibitor Clinical Development

  Merck and GE Healthcare Collaborate on Use of Imaging Biomarkers for
  Investigational BACE inhibitor Clinical Development Program

Business Wire

WHITEHOUSE STATION, N.J. & PRINCETON, N.J. -- December 18, 2012

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and GE
Healthcare today announced a clinical study collaboration, license and supply
agreement for use of [^18F]Flutemetamol, an investigational positron emission
tomography (PET) imaging agent, to support Merck's development of MK-8931, a
novel oral beta amyloid precursor protein site cleaving enzyme (BACE)
inhibitor and Merck's lead investigational candidate for Alzheimer's disease

Accumulation of beta amyloid in the brain is a pathological characteristic
related to Alzheimer’s disease. Currently, AD is diagnosed by clinical
examination (i.e., medical history, physical, neurological, psychiatric and
neuropsychological exams, laboratory tests and Magnetic Resonance Imaging
[MRI] or Computed Tomography [CT] scan). An AD diagnosis can only be confirmed
through histopathological identification of characteristic features, including
beta amyloid plaques, in post-mortem brain samples.

"There is a serious unmet need for a reliable method for measuring beta
amyloid deposits to help physicians diagnose Alzheimer’s disease at its
different stages and study its progression," said Darryle Schoepp, Ph.D.,
senior vice president, head of neuroscience and ophthalmology, Merck Research
Laboratories. "This agreement will allow us to employ an investigational
imaging agent to help identify patients who might benefit from an anti-amyloid
therapy and enable clinical evaluation of our lead BACE inhibitor candidate
for Alzheimer's disease, MK-8931."

Under the agreement, GE Healthcare will supply [^18F]Flutemetamol to help
select patients for clinical trials and evaluate this investigational agent as
a companion diagnostic tool. A joint Merck and GE Healthcare Imaging Advisory
Committee will oversee the planned imaging studies.

“In clinical trials, [^18F]Flutemetamol demonstrated consistent performance in
the visual detection of beta amyloid in the brain when compared with
histopathology data,” said Jonathan Allis, general manager, PET, GE Healthcare
Medical Diagnostics. “[^18F]Flutemetamol imaging has the potential to be part
of a larger diagnostic workup that may help doctors rule out Alzheimer’s
disease by reliably showing the absence of amyloid deposits in patients with
unexplained loss of cognitive function.”

About Merck’s BACE Inhibitor Development Program and MK-8931

Merck is advancing several innovative programs in Alzheimer's disease,
including candidates designed to modify disease progression as well as improve
symptom control. Merck's lead candidate in disease modification is MK-8931, an
investigational oral BACE inhibitor.

Results of Phase I clinical studies demonstrated that MK-8931 can reduce
cerebral spinal fluid (CSF) beta amyloid by greater than 90 percent in healthy
volunteers without dose limiting side effects. Based on these results, Merck
is moving forward with a global, multi-center Phase II/III clinical trial,
called EPOCH, to evaluate the safety and efficacy of MK-8931 versus placebo in
patients with mild-to-moderate AD. For more information about the EPOCH study
please visit or call 1-855-55-EPOCH (37624). Information
is also available at

About [^18F]Flutemetamol

[^18F]Flutemetamol is an investigational PET imaging agent being developed by
GE Healthcare for the detection of beta amyloid deposits in the brain. Pooled
results from Phase III brain autopsy and biopsy studies showed a strong
concordance between [18F]Flutemetamol images and AD-associated beta amyloid
brain pathology. Phase III studies demonstrated [18F]Flutemetamol visual
detection of beta amyloid with a majority read sensitivity of 86 percent and
specificity of 92 percent.

About Alzheimer's Disease and Amyloid Hypothesis

Alzheimer’s disease (AD) is a devastating, irreversible and ultimately fatal
disease that progressively destroys neurons in the brain, leading to a
deterioration of cognitive function. The symptoms include loss of memory that
progresses into behavioral changes, alterations in thinking and reasoning
skills that interfere with daily activities, and dementia. AD is the most
common cause of dementia, accounting for approximately 50-75 percent of the
estimated 35 million dementia cases globally.^1,2 About 5.4 million people in
the United States are currently living with AD.^3 There are currently no
disease-modifying treatments available for AD, and current treatment options
are limited to providing symptomatic improvements with only modest and
short-term effects.

While the exact cause of AD remains unknown, a current prevailing theory
asserts that AD occurs due to the accumulation of beta amyloid proteins in the
brain. Beta amyloid precursor protein site cleaving enzyme (BACE) is believed
to be a key enzyme in the production of beta amyloid peptide. Evidence
suggests that inhibiting BACE decreases the production of beta amyloid and may
therefore reduce amyloid plaque formation and modify disease progression.


GE Healthcare provides transformational medical technologies and services that
are shaping a new age of patient care. Ourbroad expertise in medical imaging
and information technologies, medical diagnostics, patient monitoring systems,
drug discovery, biopharmaceutical manufacturing technologies, performance
improvement,and performance solutions services helpsour customers deliver
better care to more people around the world at a lower cost. In addition,
wepartnerwith healthcare leaders, striving toleverage the global policy
change necessary to implementa successful shift to sustainable healthcare

Our "healthymagination" vision for the future invites the world tojoin us on
our journey as we continuously develop innovations focused on reducing costs,
increasing access,and improving quality around the world. Headquartered in
the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE:
GE). Worldwide, GE Healthcareemployees are committed to serving healthcare
professionals and their patients in more than 100 countries. For more
information about GE Healthcare, visit our web site at

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.

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. 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; 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 2011
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

^1 Alzheimer’s Disease International. Types of Dementia: Alzheimer’s Disease.
Available at:

^2 Alzheimer’s Disease International. Dementia Statistics. Available at:

^3 Alzheimer’s Association. Alzheimer’s Fact and Figures. Available at:

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Aleisia Gibson, 201-289-3832
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