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
WHITEHOUSE STATION, N.J. & AUSTIN, Texas--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.
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).