Drug-device maker Kaléo has secured a federal contract worth $96.1 million, enlisting in an effort to bolster U.S. biodefense.
Granted by the Biomedical Advanced Research and Development Authority (BARDA), the funding will help advance the company’s pralidoxime chloride (2-PAM) auto-injector from late-stage development toward deployment for national preparedness.
Pralidoxime is an oxime drug used for the treatment of exposure to nerve agents, or organophosphate poisoning, which can become life-threatening within minutes by disrupting acetylcholinesterase, an enzyme critical for normal nerve signaling. Timely delivery of 2-PAM can restore enzyme activity, making fast, easy administration vital—the exact goal of Kaléo’s auto-injector.
The award supports late-stage development, manufacturing validation, FDA regulatory activities and initial procurement of the auto-injectors for national stockpiles, such as the CHEMPACK program managed by BARDA’s parent agency, the Administration for Strategic Preparedness and Response.
Furthermore, if the U.S. government chooses to exercise additional options under the agreement, the value of the contract could balloon by an extra $244.8 million, according to Kaléo.
“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,” the company’s CEO, Michael Wells, said in a statement. “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.”
The new grant builds upon a prior collaboration formed between BARDA and Kaléo in 2024 to support development of the new 2-PAM auto-injector.
Besides national preparedness efforts, Kaléo sells an epinephrine auto-injector called Auvi-Q and a naloxone auto-injector on the commercial market.
In August, the Virginia company out-licensed certain patented auto-injector technology to Amgen.