Cerus Corp. (NASDAQ: CERS), a biomedical products company focused on improving blood transfusion safety, said it will receive funding of up to $180 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support a clinical development program for pathogen reduction of red blood cell (RBC) components, to improve national emergency preparedness for epidemic and endemic blood-borne pathogens such as Zika, dengue, and chikungunya.
The five-year contract between Cerus and BARDA includes a base period with committed funding of up to $30.7 million and subsequent option periods that would bring the total funding to up to $180.5 million over five years.
BARDA, which is part the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
The Intercept Blood System is a pathogen reduction technology designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria, parasites, and leukocytes that may be present in donated blood.
Intercept pathogen reduction technology for platelets and plasma has been used in Europe for over 10 years as a safety measure to reduce the risk of transfusion-transmitted infections in platelet and plasma components, and was in routine use in French Polynesia and the French West Indies during the Zika outbreak in 2013-2014.
Cerus received FDA approvals for the Intercept Blood System for platelets and plasma in December 2014, and the system is now in routine use in a number of blood centers across the United States. Intercept was approved for platelets and plasma in Brazil in December 2015.
Cerus reported positive results of the Intercept Red Blood Cell System from a European Phase III clinical trial in January 2015, and also from a U.S. Phase II clinical trial in December 2014. The Company plans to submit an application for CE Mark registration of Intercept RBCs in the second half of 2016.
The nucleic acid targeting mechanism of action of the Intercept treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as Chikungunya, malaria and dengue.
Cerus currently markets and sells the Intercept Blood System for both platelets and plasma in the United States, Europe, Russia, the Middle East and other regions around the world. The Intercept red blood cell system is in clinical development. Cerus Corp. was founded in 1991 and is headquartered in Concord, California.