Organophosphate Poisoning

Solon, OH: CMC Pharmaceuticals has been awarded a Sequential Phase II Small Business Innovation Research (“SBIR”) grant from the U.S. Defense Department’s (“DoD”) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Threat Reduction Agency. The award funds the continued development of a promising medical countermeasure (“MCM”) for nerve agents that contain a stable, fixed-dose combination formulation of atropine and scopolamine. “This newly-awarded grant allows CMC Pharma to continue developing an MCM to protect our Service Members against nerve agents,” said Dr. Mike Radomsky, Principal Investigator and President of CMC Pharma. “We identified promising lead formulations in earlier SBIR grants and this award gives us the opportunity to expand on that work. Over the next two years, we will be performing proof-of-concept nonclinical studies and chemistry, manufacturing, and controls activities to ready the program for pre-IND discussions with FDA. Additionally, we will identify an appropriate cGMP drug product manufacturing site for material needed for IND-enabling and clinical studies.” CMC Pharma recognizes the current and future threat of chemical and biological warfare to the warfighter. The objective of this program is to develop a combination drug product that is a stable and effective treatment for organophosphate nerve agent poisoning. A combined formulation of atropine and scopolamine could increase the therapeutic efficacy of the current treatment regimen while minimizing the logistical burden associated with carrying and administering a multi-drug MCM regimen. This development effort will bridge the gap between laboratory-scale innovation (i.e., CMC Pharma’s previous effort) and entry into an FDA regulatory pathway leading to commercialization. CMC Pharma plans to execute future studies to support FDA approval of the drug product and secure the appropriate supply chain, with the vision of providing the drug product for DoD issuance to service members stationed in areas of Nerve Agent Threat Potential and supplying the Strategic National Stockpile. CMC Pharma has successfully managed a wide variety of pharmaceutical development programs, including multi-year programs with the federal government. In addition, CMC Pharma possesses significant experience with scopolamine and atropine formulations. The continued development of this new combination product not only leans on existing expertise but helps to advance corporate strategy to provide world-class drug development services to the DoD to develop medical countermeasures to address threats to the warfighter. CMC Pharma has a portfolio of MCM products for chemical defense funded by DoD and is seeking development, manufacturing, and commercialization partners for this chemical defense MCM portfolio. The contract number for this grant is W911SR22C0047. For more information about CMC Pharma’s drug product formulation expertise and services, visit . About CMC Pharmaceuticals: CMC Pharmaceuticals (CMC Pharma) is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharma delivers specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development, and consulting services to clients globally. CMC Pharma offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile injectables, solid oral, long-acting, controlled release, and other complex dosage forms. ###