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Home Contract Awards Rafa Laboratories Lands $186M BARDA Contract for Intramuscular TXA Development
Rafa Laboratories has received a potential $186 million contract from the Biomedical Advanced Research and Development Authority to develop an intramuscular formulation of tranexamic acid, or IM TXA, a potential treatment for uncontrolled bleeding.
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The company said Wednesday the award marks its second major contract with BARDA and addresses the urgent need for a rapidly deployable treatment for hemorrhage in prehospital settings by focusing on TXA, an antifibrinolytic agent designed to treat trauma bleeding in both prehospital and hospital settings. Uncontrolled bleeding is the top cause of preventable deaths after trauma, whether from accidents, mass-casualty incidents or battlefield injuries.
“The IM TXA development contract marks a strategic expansion of Rafa’s presence in acute trauma care. We are deeply committed to partnering with BARDA to accelerate the delivery of this urgently needed, life-saving solution to hundreds of thousands of patients across the globe,” said Iddo Leshem, CEO of Rafa Laboratories.
What Is the Scope of the BARDA TXA Development Contract?
Rafa plans to develop an intramuscular TXA injection that simplifies administration compared with the current intravenous method, which requires trained personnel. The company also intends to develop a TXA autoinjector to enable both professional and nonprofessional caregivers to administer the treatment instantly.
“The clock starts ticking the moment a patient sustains a hemorrhagic injury, and the few minutes before reaching a hospital are the most critical ones,” said Roy Shay, vice president of biodefense at Rafa Laboratories.
“Developing a new intramuscular TXA injection is a potential game-changer as it simplifies the administration process, especially if administered with an autoinjector,” Shay added.
Under the contract, the company will adopt an integrated product development approach, which will include formulation development, preclinical and clinical trials, manufacturing scale-up and a streamlined regulatory pathway aimed at securing approval from the Food and Drug Administration.
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