Merck, Luminex to develop AD companion diagnostic device

WHITEHOUSE STATION, N.J.—Merck and Luminex, an Austin,Texas-based biotechnology company, have announced the signing of acollaboration and license agreement under which they will develop a companiondiagnostic device. The device will be evaluated for its usefulness in screeningpatients for recruitment into Merck's clinical development program for its leadinvestigational candidate for Alzheimer's disease, MK-8931. Per the terms ofthe agreement, Luminex will be in charge of development, regulatory submissionand commercialization of the companion diagnostic device candidate. Nofinancial details for the agreement were disclosed.

"This collaboration has the potential to deliver a novelcompanion diagnostic to identify patients at increased risk of developingAlzheimer's disease," Patrick J. Balthrop, president and CEO of Luminex, saidin a press release regarding the deal. "We are pleased to leverage ourtechnologies and development capabilities and look forward to expanding ouractivity into the companion diagnostic segment of personalized medicine."

The companion diagnostic device will make use of Luminex'sxMAP Technology to measure concentrations of Aß42 and t-tau, two candidatebiomarkers, in cerebrospinal fluid samples from patients diagnosed with mildcognitive impairment. The partners will determine the candidate device'sefficacy as a means to identify subjects with mild cognitive impairment whohave a higher risk of developing Alzheimer's disease, an identification processthat will aid Merck in selecting patients for its beta amyloid precursorprotein site cleaving enzyme (BACE) inhibitor clinical program.

Beta amyloid accumulation in the brain has long been citedas one of Alzheimer's disease's key pathological characteristics, and recentresearch has revealed that there is support for the belief that measuring Aß42and t-tau in cerebrospinal fluid samples could be helpful in identifyingpatients with a predisposition to developing the disease.

"Evaluation of biomarkers that may provide an indicator ofdisease onset and enable earlier diagnosis is an important goal towardfacilitating early intervention and potentially improving the treatment ofAlzheimer's disease. We look forward to working with Luminex to advance ourongoing clinical development program for MK-8931," Dr. Darryle D. Schoepp, senior vice president and head of the Neuroscience and Ophthalmology division at MerckResearch Laboratories, commented in a statement.

MK-8931 is a novel, investigational, oral BACE inhibitorthat in Phase I clinical trials have been shown to reduce beta amyloid levelsin cerebrospinal fluid by greater than 90 percent in healthy volunteers as wellas Alzheimer's disease patients, with no demonstrable dose-limiting sideeffects. Merck is now moving forward into a global Phase II/III clinical trial,EPOCH, to determine the compound's safety and efficacy versus a placebo inpatients with mild to moderate Alzheimer's disease.

SOURCE: Merck press release