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Developing a solid BACE
WHITEHOUSE STATION, N.J.—In an effort to better support patient selection for the clinical development of MK-8931, Merck & Co.'s lead investigational medicine for Alzheimer's disease, the company—which is known as MSD outside the United States and Canada—has signed a collaboration deal with Austin, Texas-based Luminex Corp.
Specifically, the deal calls for Luminex to be responsible for development, regulatory submission and commercialization of the candidate companion diagnostic device 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.
The device will build off Luminex's xMAP technology, with the goal of measuring concentrations of two candidate biomarkers, Aβ42 and t-tau, in cerebrospinal fluid samples from patients with mild cognitive impairment. The candidate device will be evaluated as a means to identify subjects with mild cognitive impairment who have a higher risk of developing Alzheimer's as Merck selects patients for its BACE inhibitor clinical program.
According to Dr. Darryle D. Schoepp, senior vice president and head of the Neuroscience and Ophthalmology division at Merck Research Laboratories, "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." And, as he notes, recent clinical evidence supports the hypothesis that the measurement of the investigational biomarkers Aβ42 and t-tau in cerebrospinal fluid may be useful in identifying patients at greater risk of developing Alzheimer's disease, which currently is diagnosed by clinical examination—primarily, medical history; physical, neurological, psychiatric and neuropsychological exams; and magnetic resonance imaging or computed tomography scans have been used for this purpose.
Patrick J. Balthrop, president and CEO of Luminex, says he looks forward to "leveraging our technologies and development capabilities and … expanding our activity into the companion diagnostic segment of personalized medicine " and is confident in the potential for this collaboration to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer's disease.
Zacks Investment Research, which currently gives Merck a Zacks Rank #3 (Hold) rating, wrote in an investor's note, "We view MK-8931 as a high risk-high return candidate for Merck. The successful development of therapies for the treatment of Alzheimer's disease is challenging, and we note that several companies, including Medivation, have failed in developing treatments for the same."
However, Zacks also concedes that the Alzheimer's disease market represents huge commercial potential and therefore attracts a lot of interest.
"A successfully developed product could generate billions of dollars in sales once launched," Zacks notes. "As per data provided by the Alzheimer's Association, approximately 5.2 million people have Alzheimer's disease in the U.S. alone," and adds of Merck: "While headwinds remain in the form of the Singulair genericization, EU pricing pressure, unfavorable currency movement, U.S. healthcare reform and pipeline setbacks, some of the company's recent launches should start contributing significantly to the top line in the forthcoming quarters."
Financial terms for the Merck-Luminex deal were not disclosed.
In related news, Merck and GE Healthcare in December 2012 announced a clinical study collaboration, license and supply agreement for use of [18F]Flutemetamol, an investigational positron emission tomography imaging agent, to support development of MK-8931.
Merck is advancing what it calls "several innovative programs" in Alzheimer's disease, including candidates designed to modify disease progression as well as improve symptom control. As for its lead candidate in disease modification, MK-8931, results of Phase I clinical studies of the BACE inhibitor reportedly have demonstrated that MK-8931 can reduce levels of beta amyloid in cerebrospinal fluid by greater than 90 percent in healthy volunteers and people with Alzheimer's disease 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 Alzheimer's and has plans to initiate a trial in prodromal subjects.
In addition to the xMAP pen-architecture multi-analyte platform, the proprietary instruments and assays at Luminex include MultiCode real-time polymerase chain reaction (PCR) and multiplex PCR-based technologies that, as the company maintains, "deliver cost-effective rapid results to clinicians and researchers."