Kaléo, a privately-held U.S. pharmaceutical company, announced in July that the U.S. Department of Defense (DoD) has selected them to develop a Reconstitution Auto-Injector Device that delivers atropine (RAD-A).
In the initial press release published in July, Kaléo writes that it 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 $39 million over the next five years.
Colonel Matthew G. Clark, Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) at the U.S. DoD, said that “the goal for this project is to produce an auto-injector device capable of automatically reconstituting a range of military countermeasures.”
“This is an exciting new addition to the suite of auto-injector products that enable a layered defense against CBRN threats for the Warfighter.”
Kaléo writes that unlike the currently fielded atropine auto-injectors, 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 auto-injector products that constitute a layered defense against CBRN threats for military personnel and potentially civilian stockpiles.
Mark A. Herzog, Kaléo’s Vice President of Global Corporate Affairs, Defense and Homeland Security, said that their 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.”
The contract on the development of a new RAD-A is the second DoD contract to have been 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 in 2022.
The full original press release can be read on Kaléo’s website, here.
About Kaléo: Kaléo is a fully integrated pharmaceutical company dedicated to inventing, manufacturing, and commercializing life-transforming products for certain serious and life-threatening medical conditions. Kaléo’s innovative auto-injection technologies are protected by an extensive intellectual property portfolio of more than 200 issued patents as well as meeting the U.S. Food and Drug Administration (FDA) draft guidance standard for 99.999% device reliability. Kaléo is headquartered in Richmond, Virginia in the United States. For more information, visit www.kaleo.com.