WHITEHOUSE STATION, N.J. & PRINCETON, N.J.--(Business Wire)--
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 (AD).
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
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 www.ADstudyinfo.com or call 1-855-55-EPOCH (37624). Information is also
available at www.clinicaltrials.gov.
[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.
ABOUT GE HEALTHCARE
GE Healthcare provides transformational medical technologies and services that
are shaping a new age of patient care. Our broad expertise in medical imaging
and information technologies, medical diagnostics, patient monitoring systems,
drug discovery, biopharmaceutical manufacturing technologies, performance
improvement, and performance solutions services helps our customers deliver
better care to more people around the world at a lower cost. In addition, we
partner with healthcare leaders, striving to leverage the global policy change
necessary to implement a successful shift to sustainable healthcare systems.
Our "healthymagination" vision for the future invites the world to join 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 Healthcare employees 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 www.gehealthcare.com.
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
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 (www.sec.gov).
1 Alzheimer`s Disease International. Types of Dementia: Alzheimer`s Disease.
Available at: http://www.alz.co.uk/info/alzheimers-disease.
2 Alzheimer`s Disease International. Dementia Statistics. Available at:
3 Alzheimer`s Association. Alzheimer`s Fact and Figures. Available at:
Photos/Multimedia Gallery Available:
Caroline Lappetito, 267-305-7639
Aleisia Gibson, 201-289-3832
Investor Relations Contacts:
Carol Ferguson, 908-423-4465
Copyright Business Wire 2012