Siemens' PETNET to manufacture investigational tau imaging agent

Phase III clinical trial starts in 2018

February 13, 2017
by Lauren Dubinsky , Senior Reporter
Cerveau Technologies recently signed an agreement with Siemens’ PETNET Solutions that grants the company the right to manufacture its investigational tau imaging agent.

The [F-18]MK-6240 PET agent is currently under evaluation for imaging neurofibrillary tangles in the brain. NFTs that are made up of aggregated tau proteins are known as the pathologic hallmark of certain neurodegenerative diseases including Alzheimer’s disease.

The pharmaceutical company Merck initially developed [F-18]MK-6240 and then signed a license agreement with Cerveau last month for the global development and commercialization of the imaging agent.

Cerveau plans to initiate a Phase III clinical trial in early 2018. As part of the new agreement, PETNET will manufacture [F-18]MK-6240 clinical trial material at select radiopharmacies in the U.S. with the possibility of expanding into additional locations.

PETNET has over 50 PET radiopharmaceutical drug manufacturing facilities and dispensing nuclear pharmacies worldwide. The CEO of the company, Barry Scott, stated that its large network of radiopharmacies will be needed to support the availability of [F-18]MK-6240.

Early studies conducted by Merck scientists found that [F-18]MK-6240 has a high specificity and selectivity for NFTs. It also has “favorable physicochemical properties and in vivo pharmacokinetics that warranted clinical investigation as a potential PET neuroimaging agent.”

“There is a critical need for sensitive biomarkers for diagnosis and monitoring of tau pathology in neurodegenerative diseases, to allow for more appropriate staging of disease states, and measuring the effect of candidate disease-modifying therapeutics,” Darryle Schoepp, vice president discovery at Merck Research Laboratories, said in a statement in January.

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