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U.S. Department of Defense Selects Kaléo to Develop Next Generation Nerve Agent Countermeasure

Kaléo, a privately-held U.S. pharmaceutical company, today announced their selection by the U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) to develop a reconstitution auto-injector device that delivers atropine, the Reconstitution Auto-Injector Device – Atropine (RAD-A). This will be the first of a new generation of medical countermeasures utilizing an innovative reconstitution technology and is expected to significantly extend the shelf life of the drug as well as its stability under extreme conditions. The reconstitution development contract is valued at more than $39 million over the next five years.

“The goal for this project is to produce an auto-injector device capable of automatically reconstituting a range of military countermeasures,” said Colonel Matthew G. Clark, Joint Project Manager for JPM CBRN Medical. “This is an exciting new addition to the suite of auto-injector products that enable a layered defense against CBRN threats for the Warfighter.”

Unlike the currently fielded atropine autoinjectors, the RAD-A will maintain the atropine in a dry format until the drug is automatically reconstituted into a liquid immediately prior to administration. Atropine sulfate injection is used for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides. The DOD intends the RAD-A to be an important addition to the auto-injector products that constitute a layered defense against CBRN threats for military personnel and potentially civilian stockpiles.

“Kaléo’s platform technology is well suited to handle the next generation of medical countermeasures that require wet/dry formulations, large volumes, high viscosity, the simultaneous delivery of multiple drugs, or other needs to support the Joint Force and our allies.” said Mark A. Herzog, Kaléo’s vice president, global corporate affairs, defense and homeland security.

The Other Transaction Agreement for the RAD-A prototype was awarded through the Army Contracting Command Aberdeen Proving Ground (ACC-APG), Edgewood Division, on behalf of the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in collaboration with the Chemical and Biological Defense Program (CBDP). The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the Nation’s CBRN response capability.

RAD-A is the second DOD contract awarded to Kaléo. In 2019, the company was selected by JPM CBRN Medical to develop the Naloxone Auto-injector 10 mg Rapid Opioid Countermeasure System (ROCS), which was delivered under budget, six months ahead of schedule, and approved by the U.S. Food and Drug Administration (FDA) in 2022. The JPM CBRN Medical Rapid Opioid Countermeasure System (ROCS) product team was selected to receive the 2022 MHSRS award for Outstanding Program Management in recognition of the team’s ability to minimize the ROCS program’s developmental risks, manage costs, schedule, and performance, and adhere to all applicable regulatory requirements.

 

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