Rafa Laboratories, a global leader in Chemical, Biological, Radiological, and Nuclear hazards medical countermeasures and Biodefense, today announced it has been awarded with a landmark development contract by the Biomedical Advanced Research and Development Authority (BARDA), part of Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services (HHS), for the advanced development of a novel intramuscular (IM) formulation of tranexamic acid (TXA)—a potentially life-saving therapy for uncontrolled bleeding. The contract is valued at up to $186 million, including all option periods.
This pivotal collaboration, which represents Rafa’s second major contract with BARDA, addresses an urgent global need: a rapidly deployable, easy-to-administer treatment for hemorrhage in the critical prehospital setting.
Addressing the Critical Window to Save Lives
Uncontrolled bleeding is the leading cause of preventable death following trauma, whether caused by accidents, mass-casualty events or in the battlefield. Caregivers need a tool which can be easily administered to a large number of casualties in a short period of time. TXA is an antifibrinolytic agent commonly used off label around the world to treat trauma bleeding in the pre-hospital and hospital space.
Landmark clinical studies performed in tens of thousands of individuals have demonstrated that TXA can significantly reduce mortality rates if administered quickly enough following trauma hemorrhagic injury.
“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. “Currently, TXA is typically administered intravenously (IV), which is challenging, time-consuming and requires training. The need for trained individuals even greater in high-stress, or mass-casualty situations. Developing a new intramuscular TXA injection is a potential game-changer as it simplifies the administration process, especially if administered with an autoinjector.
As planned under the potential scope of this project, Rafa shall also develop a TXA autoinjector which will enable professional as well as nonprofessional care givers to deliver this essential treatment instantly—dramatically increasing survival chances worldwide.”
“The IM route offers a fast, reliable, and user-friendly alternative for the existing IV administration, which can be extremely difficult in patients experiencing severe shock”.
BARDA and Rafa are Collaborating on a Comprehensive Development Approach
Rafa Laboratoriesis adopting a robust and integrated product development approach, which is planned to include formulation development, manufacturing scale-up, pre/clinical trials and a streamlined regulatory pathway designed to secure U.S. Food and Drug Administration (FDA) approval.
“Over the past four decades, Rafa has built a reputation for developing highly dependable medical countermeasures targeting acute, life-threatening conditions, mainly CBRN and pain management.” said Iddo Leshem, Chief Executive Officer of Rafa Laboratories. “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”.
