ALACHUA, Fla. & JERUSALEM–(BUSINESS WIRE)–Resilience, Inc., a biologics contract development and manufacturing organization (CDMO), and Rafa Laboratories, Ltd. (Rafa), a leading Israeli pharmaceutical company, today announced that on July 9, 2018, they received full approval from the U.S. Food and Drug Administration (FDA) for the Atropine Injection, 2mg/0.7mL, Single-Dose Autoinjector. The Atropine Autoinjector initially received Emergency Use Authorization from the FDA in April 2017. Atropine is one of the most commonly used drugs for the treatment of chemical nerve agent poisoning. With the approved autoinjector, U.S. troops can rapidly inject atropine into the thigh muscle following nerve agent exposure.
This FDA approval decreases reliance on a sole source drug product and device manufacturer and ensures that the Department of Defense (DoD), U.S. Government stakeholders, and international partners can quickly and cost-effectively procure the Atropine Autoinjector in the event of a nerve agent threat. There is substantial potential for a public health emergency involving nerve agents and certain insecticides. The usage of these agents can affect national security as well as the health and security of U.S. citizens living abroad.
The Joint Project Management Office for Medical Countermeasure Systems (JPM-MCS) Chemical Defense Pharmaceuticals (CDP) Project Management Office, funded and led the collaboration for development of the Atropine Autoinjector, which also included the FDA, Centers for Disease Control and Prevention (CDC) and Battelle.
“FDA approval of the Atropine Autoinjector serves to further demonstrate the strength of our expertise, as well as our ongoing commitment to bringing medical countermeasures to the U.S. military,” said Dr. Doris Snow, Vice President, Global Regulatory Affairs at Resilience. “Moreover, having worked successfully alongside Rafa since 2015, we are delighted to have the opportunity to expand this important partnership as the company’s U.S. Agent.”
Rafa Laboratories, Ltd., incorporated in 1937, is one of Israel’s leading pharmaceutical companies. The company specializes in marketing, manufacture and distribution of proprietary and generic formulations, prescription and over-the-counter medicines, as well as therapeutic products in various medical fields such as pain, gastroenterology, respiratory diseases and dermatology.
One of Rafa’s fields of expertise is the manufacture of drugs for other companies, implementing the contract manufacturing method, and it offers a range of services under a one-stop-shop concept.
Rafa has an advanced manufacturing facility approved for production in Israel, Europe and additional countries in the world. To date, Rafa is the only company in Israel having the capacity for mass production of sterile and aseptic ampoules, and it manufactures, markets and exports ampoules for use in hospitals and clinics as well as syringes for military and civil defense uses.
About Medical Countermeasure Systems Chemical Defense Pharmaceuticals Product Management Office
MCS-CDP delivers Food and Drug Administration-approved, lifesaving medical countermeasure therapeutics against emerging chemical, radiological, and nuclear threats. It is a program within JPM-MCS, which facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability. The JPM-MCS is a component of the U.S. DoD.
Resilience is a full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing, from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in its state-of-the-art, Department of Defense Advanced Development and Manufacturing Facility in Florida. The company’s infrastructure provides unique services to its clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3). Resilience has 20 years of experience developing and manufacturing drugs and biologics for the U.S. Government, with over $500M in government contracts awarded over that time. The team at Resilience has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics.