Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer’s Disease


March 13, 2013 8:30 am ET

Collaboration to Support Patient Selection for the Clinical Development of MK-8931, Merck’s Lead Investigational Medicine for Alzheimer’s Disease

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
and Luminex Corporation (NASDAQ:LMNX) have signed a collaboration and
license agreement to develop a companion diagnostic device that will be
evaluated to help screen patients for recruitment into Merck’s clinical
development program for 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). Financial terms
were not disclosed.

“Evaluation of biomarkers that may provide an indicator of disease onset
and enable earlier diagnosis is an important goal toward facilitating
early intervention and potentially improving the treatment of
Alzheimer’s disease,” said Darryle D. Schoepp, Ph.D., senior vice
president, head of Neuroscience and Ophthalmology at Merck Research
Laboratories. “We look forward to working with Luminex to advance our
ongoing clinical development program for MK-8931.”

Luminex will be responsible for development, regulatory submission and
commercialization of the candidate companion diagnostic device, which
will employ Luminex’s xMAP® Technology to measure concentrations of two
candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid (CSF)
samples from patients with mild cognitive impairment (MCI). The
candidate device will be evaluated as a means to identify subjects with
MCI who have a higher risk of developing AD to support patient selection
for Merck’s therapeutic BACE inhibitor clinical program.

“This collaboration has the potential to deliver a novel companion
diagnostic to identify patients at increased risk of developing
Alzheimer’s disease,” added Patrick J. Balthrop, president and CEO of
Luminex. “We are pleased to leverage our technologies and development
capabilities and look forward to expanding our activity into the
companion diagnostic segment of personalized medicine.”

The accumulation of beta amyloid in the brain is a key pathological
characteristic related to AD. Recent clinical evidence supports the
hypothesis that the measurement of the investigational biomarkers Aβ42
and t-tau in CSF may be useful in identifying patients at greater risk
of developing AD. Currently, AD is diagnosed by clinical examination
(i.e., medical history; physical, neurological, psychiatric and
neuropsychological exams; and Magnetic Resonance Imaging [MRI] or
Computed Tomography [CT] scan). An AD diagnosis can only be confirmed by
histopathological identification of core features, including beta
amyloid deposits and plaques, in post-mortem brain samples.

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 treatment options are limited to providing
symptomatic improvements with only modest and short-term effects.

While the exact cause of AD remains unknown, the current prevailing
hypothesis 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, which contributes to the formation of plaques
in the brain. Evidence suggests that inhibiting BACE decreases the
production of beta amyloid and may therefore reduce amyloid plaque
formation and modify disease progression.

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
levels of beta amyloid in cerebral spinal fluid (CSF) by greater than 90
percent in healthy volunteers and people with AD without dose-limiting
side effects. Based on these results, Merck is conducting a global,
multi-center Phase II/III clinical trial, EPOCH, to evaluate the safety
and efficacy of MK-8931 versus placebo in patients with mild-to-moderate
AD and has plans to initiate a trial in prodromal subjects. Information
is also available at

In December 2012, Merck and GE Healthcare announced a clinical study
collaboration, license and supply agreement for use of [18F]Flutemetamol,
an investigational positron emission tomography (PET) imaging agent, to
support development of MK-8931.

About Luminex Corporation

Luminex is committed to applying its passion for innovation toward
creating breakthrough solutions to improve health and advance science.
The company is transforming global healthcare and life-science research
through the development, manufacturing and marketing of proprietary
instruments and assays utilizing xMAP® open-architecture multi-analyte
platform, MultiCode® real-time polymerase chain reaction (PCR), and
multiplex PCR-based technologies, that deliver cost-effective rapid
results to clinicians and researchers. Luminex’s technology is
commercially available worldwide and in use in leading clinical
laboratories, as well as major pharmaceutical, diagnostic, biotechnology
and life-science companies. Luminex is meeting the needs of customers in
markets as diverse as clinical diagnostics, pharmaceutical drug
discovery, biomedical research including genomic and proteomic research,
personalized medicine, biodefense research and food safety. For further
information on Luminex Corporation and the latest advances in
multiplexing using award winning technology, please visit

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.

Luminex Forward-Looking Statement

Statements made in this release that express Luminex’s or management’s
intentions, plans, beliefs, expectations or predictions of future events
are forward-looking statements. Forward-looking statements in this
release include statements regarding our collaboration with Merck to
develop, manufacture and distribute a companion diagnostic product for
detection of Alzheimer’s disease. The words “believe,” “expect,”
“intend,” “estimate,” “anticipate,” “will,” “could,” “should” and
similar expressions are intended to further identify such
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. It is important to note that the
Company’s actual results or performance could differ materially from
those anticipated or projected in such forward-looking statements.
Factors that could cause Luminex’s actual results or performance to
differ materially include risks and uncertainties relating to, among
others, market demand and acceptance of this product and Luminex
technology generally, our ability to ability to complete product
development, scale up manufacturing, secure required regulatory
clearance, and distribute the product, as well as the risks discussed
under the heading “Risk Factors” in Luminex’s Reports on Forms 10-K and
10-Q, as filed with the Securities and Exchange Commission. The
forward-looking statements contained herein represent the judgment of
Luminex as of the date of this press release, and Luminex expressly
disclaims any intent, obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements to reflect any
change in Luminex’s expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements are

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 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 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 (


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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