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U.S. Department of Health and Human Services Awards Kaléo with Contract to Develop Next Generation Organophosphate Nerve Agent Poisoning Countermeasure

The full development contract with options totals $27.7 million

Richmond, Virginia (April 17, 2024) – Kaléo, a privately-held U.S. pharmaceutical company today announced their selection by the Biomedical Advanced Research and Development Authority (BARDA), part of Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to develop the latest generation pralidoxime chloride auto-injector as a countermeasure against organophosphate or nerve agent poisoning. The full development contract with options totals $27.7 million.

The contract tasks Kaléo with developing a novel pralidoxime chloride (2-PAM) auto-injector for U.S. Food and Drug Administration (FDA) approval within 3 years, with an ultimate goal of enabling later procurement of the 2-PAM auto-injectors for the CHEMPACK program. Kaléo is a market leader in emergency use auto-injectors with more than 12 million devices manufactured to meet the FDA’s standard of 99.999% device reliability.

“The development of a novel, next generation pralidoxime chloride auto-injector is an exciting opportunity,” said Mark A. Herzog, Kaléo’s vice president of global corporate affairs, defense and homeland security. “While Kaléo has many years of experience working with the U.S. Department of Defense, this will be our first opportunity to work with BARDA to develop a medical countermeasure for the CHEMPACK program.”

The CHEMPACK Program, an initiative of the Administration for Strategic Preparedness and Response (ASPR), is designed to provide a comprehensive capability to communities for the effective use of medical countermeasures in the event of an attack with nerve agents on civilians.

The 2-PAM auto-injector is the third U.S. government medical countermeasure contract awarded to Kaléo in the last five years. Last year, Kaléo was awarded a $39 million contract by the U.S. Department of Defense (DoD) to develop the Reconstitution Auto-Injector Device – Atropine (RAD-A), the first of a new generation of medical countermeasures utilizing an innovative reconstitution technology that is expected to significantly extend shelf life, as well as stability under extreme conditions. In 2019, the company was awarded a contract by the DoD to develop the Naloxone Auto-injector 10 mg Rapid Opioid Countermeasure System (ROCS), which was approved by the FDA in 2022 and is currently fielded by U.S. military and NATO countries across the globe.

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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 ~ 200 patents and patent applications 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.

About Pralidoxime
Pralidoxime is an antidote to organophosphate pesticides including nerve agents. Organophosphates bind to the active site of acetylcholinesterase, which results initially in reversible inactivation of the enzyme. If given soon after organophosphate exposure, pralidoxime can reactivate the enzyme acetylcholinesterase by displacing the bound organophosphate from the active site. Recent studies1 indicate unintentional organophosphate poisoning affects as many as three million people annually worldwide and is responsible for some 300,000 deaths.

About Organophosphates
Poisoning by Organophosphates, including nerve agents, requires extremely rapid intervention given the quick onset of symptoms, which can manifest within minutes. Pralidoxime (2-PAM) and atropine, an anticholinergic, must be administered as soon as possible. It is important that both drugs be available in an easy-to-use form such as an autoinjector as close to the site of need as possible, as is envisioned by the CHEMPACK Program

References
1. “Cholinergic Crisis.” National Library of Medicine, National Center for Biotechnology Information. Available at: https://www.ncbi.nlm.nih.gov/books/NBK482433/#:~:text=Globally%2C%20about%20three%20million%20people,of%20agricultural%20insecticides%20or%20pesticides.

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