Kaléo, a global leader in drug-delivery device technology and auto-injector innovation, today announced it has been awarded a Project BioShield contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to support the late-stage development, regulatory approval, and initial procurement of a pralidoxime chloride (2-PAM) auto-injector for the treatment of organophosphate poisoning, including nerve agent exposure, in adult and certain pediatric populations.
The contract represents the next phase of Kaléo’s collaboration with BARDA to advance the 2-PAM auto-injector program toward regulatory approval and deployment. It follows BARDA’s 2024 award to Kaléo to support development of the next-generation 2-PAM auto-injector, marking an important progression from product development toward potential deployment for national preparedness. The funded base award of approximately $96.1 million supports late-stage development, manufacturing validation, FDA regulatory activities, and the initial procurement of 2-PAM auto-injectors for national preparedness programs. Additional options, if exercised by the government, would expand the agreement, increasing the overall scope and value of the contract by an additional $244.8 million.
“This contract award will enable Kaléo to develop and deliver critical medicines through a proven, highly reliable auto-injector platform designed to perform when every second matters,” said Michael Wells, Chief Executive Officer of Kaléo. “For more than two decades we have built deep expertise at the intersection of drugs and devices, with a focus on advancing technologies that simplify treatment delivery while maintaining the highest standards of reliability and quality. Through our continued collaboration with BARDA and ASPR, we are helping strengthen the nation’s medical countermeasure infrastructure and preparedness, helping ensure capabilities, ensuring responders have access to critical tools during chemical emergencies.”
Organophosphate poisoning, including exposure to nerve agents, can become life-threatening within minutes and requires rapid medical intervention. The development of a ready-to-use, easy-to-administer auto-injector is intended to facilitate timely treatment in emergency situations where speed, simplicity, and reliability matter.
The award builds on Kaléo’s extensive experience developing and manufacturing innovative auto-injector products and reinforces the company’s commitment to advancing reliable, patient-centered technologies that address important public health needs. With millions of auto-injectors manufactured and deployed globally, Kaléo continues to leverage expertise in drug-device innovation to help improve readiness and access to life-saving therapies for patients, caregivers, healthcare professionals, and emergency responders.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50126C00010.
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