Battelle, CMC Pharmaceuticals Advance Medical Countermeasure Program for U.S. Department of War

COLUMBUS, Ohio--(BUSINESS WIRE)--Battelle and CMC Pharmaceuticals are advancing work with the United States Department of War to develop improved medical countermeasures intended to protect American warfighters from nerve agent threats.

The five-year, $40 million Acetylcholinesterase (AChE) Reactivator Development and Approval Pipeline (ARDAP) Prototype Program was awarded through the Defense Threat Reduction Agency, Joint Science and Technology Office (DTRA-JSTO). The program is focused on advancing a promising AChE reactivator candidate through the drug development pathway toward submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration.

“Battelle has a long history of working with the DOW to develop medical countermeasures that protect military personnel from chemical threats,” said Drew Cawthon, Business Line Director. “As the ARDAP program progresses toward IND submission, we are proud to continue supporting this important mission and to continue to drive next-generation solutions to emerging threats with a strong partner like CMC Pharmaceuticals.” Ohio-based CMC Pharmaceuticals is supporting chemistry, manufacturing, and controls (CMC) activities, including laboratory development, cGMP testing, formulation and process development, stability evaluation, and Contract Manufacturing Organization oversight required to support product development and regulatory submissions.

“We are excited to team with Battelle and provide our chemistry, manufacturing, and controls expertise to such an important program,” said Mike Radomsky, President of CMC Pharmaceuticals. “Providing drug development services to the U.S. Department of War to protect our troops against the threat of nerve agents is truly an honor. This program adds to our existing and growing portfolio of improved therapeutics and medical countermeasures for the U.S. government.”

ARDAP is intended to establish a development and approval pipeline for improved AChE reactivators as medical countermeasures for nerve agent exposure. Battelle, CMC Pharmaceuticals, and program partners have advanced key CMC, nonclinical, clinical, and regulatory planning activities to support IND submission and future clinical evaluation. The effort is designed to support the efficient development of a fieldable medical countermeasure that could enhance the current standard of care for warfighters exposed to chemical threats.

About Battelle

Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

About CMC Pharmaceuticals:

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. Located in Solon, Ohio, 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, CMO oversight, and consulting services to clients globally. 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. CMC Pharma has successfully managed a wide variety of pharmaceutical development programs, including multi-year programs with the federal government. For more information, visit www.cmcpharm.com.