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Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical

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

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

Business Wire

WHITEHOUSE STATION, N.J. & AUSTIN, Texas -- March 13, 2013

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
www.clinicaltrials.gov.

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 http://www.luminexcorp.com.

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.

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 based.

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
(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:
http://www.alz.co.uk/research/statistics.

^3 Alzheimer’s Association. Alzheimer’s Fact and Figures. Available at:
http://www.alz.org/alzheimers_disease_facts_and_figures.asp.


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Contact:

Media Contacts:
Merck
Caroline Lappetito, 267-305-7639
or
Luminex
Mimi Torrington, 512-219-8020
mtorrington@luminexcorp.com
or
Investor Contacts:
Merck
Carol Ferguson, 908-423-4465
or
Luminex
Matt Scalo, 512-336-3587
mscalo@luminexcorp.com
 
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