U.S. Department of Defense Awards Rafa Laboratories Production FOLLOW-ON Agreement of over $45 million

The Advanced Anticonvulsant System (AAS) - Midazolam autoinjector, delivers enhanced capability to warfighters. This first in market product was developed by Rafa in cooperation with the U.S. Department of Defense

JERUSALEM, Feb. 23, 2023 /PRNewswire/ -- Rafa Laboratories LTD. ("Rafa") was awarded a follow-on production agreement for a total value of over $45 million (W911SR2390004) from the Defense Department's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). Under this follow-on production agreement, Rafa has manufactured and began delivering 10mg Midazolam Injection autoinjectors to the Joint Force since December 2022.

The Midazolam Injection autoinjector is indicated for the treatment of status epilepticus in adults. As such, this new Advanced Anticonvulsant System (AAS) autoinjector can be used to treat seizures resulting from nerve agent exposure. According to JPEO-CBRND, "the AAS improves upon, and will eventually replace, the currently fielded Convulsant Antidote for Nerve Agent (CANA) diazepam autoinjector. Fielding the Midazolam Injection autoinjector gives the warfighter and the Nation access to a life-saving medical countermeasure in CBRN environments."

This production agreement is a follow-on to a prototype other transaction agreement (W911QY2090014) between the two parties that led to U.S. Food and Drug Administration (FDA) approval of the Midazolam Injection autoinjector on 2022.

According to guidelines of the American Epilepsy Society, Midazolam Intramuscular is a first-line therapy for Status Epilepticus.

Rafa's innovation resides in the use of an autoinjector to be administered intramuscularly to the thigh (can be administered through clothes as well), in a simple and fast manner which does not require an intravenous line. This is a significant advantage in a field setting during an emergency, when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure.

The product was developed and is currently being manufactured at Rafa's site located in Jerusalem, Israel. It is already sold for emergency purposes to NATO member states and is an important addition to Rafa's expanding autoinjector portfolio, which includes various formulations for emergency use.

This production agreement demonstrates further cooperation between Rafa and the JPEO-CBRND, having previously collaborated on the production of Rafa's Atropine autoinjector that was launched in the U.S. in 2017.

About Rafa

Founded in 1937 and headquartered in Jerusalem, Israel, Rafa is among the leading pharmaceutical companies in Israel and a global player in emergency solutions – medical countermeasures, supplying reliable and robust auto-injectors to government agencies, military forces and civilian populations- at scale. Rafa's competencies span over the entire value chain from R&D and manufacturing by international standards (e.g. FDA, EMA) all the way through sales and marketing. With a proven track record of successful commercialization of niche and orphan products, Rafa has been privileged to nurture long-lasting alliances with leading innovative companies such as United Therapeutics, Helsinn, Zambon, Dr. Falk and Mundipharma, in a variety of therapeutic areas including oncology, hematology, respiratory, gastroenterology, and dermatology. Rafa's controlling shareholder, FIMI Opportunity Funds, is the leading private equity fund in Israel with a track record of success spanning over 25 years and assets under management of $7b. Since its inception, FIMI's performance has been exceptional by both local and global standards after having completed close to 100 investments."

For additional information, please contact Roy Shay, Head of Emergency Solutions at Rafa, [email protected]