Cerus said it has inked an up to $180.5 million agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support the company’s clinical development program for pathogen reduction of red blood cell (RBC) components.
“This contract offers the potential to fund activities related to anticipated Phase III clinical studies for the Intercept Red Blood Cell System in the United States and the required manufacturing and development activities needed to pursue a potential U.S. commercial launch,” Cerus CSO Laurence Corash, M.D., said in a statement.
Intercept is a pathogen reduction technology designed to reduce the risk of transfusion-transmitted infections by inactivating a range of pathogens that may be present in donated blood, including viruses, bacteria, parasites, and leukocytes.
Cerus reported positive results of Intercept from a European Phase III clinical trial in January 2015, and from a U.S. Phase II clinical trial a month earlier. The company said it plans to submit an application for CE Mark registration of Intercept RBCs in the second half of 2016.
Intercept for platelets and plasma received FDA approvals in December 2014, and has since been adopted into routine use in 100 blood centers in 25 countries, according to Cerus. In Europe, Intercept has been used 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. Intercept was also approved for platelets and plasma in Brazil in December 2015.
Cerus noted that both the FDA and the World Health Organization (WHO) have issued guidance acknowledging the risk of Zika virus transmission via blood transfusion, and have identified the use of pathogen reduction technology as an appropriate blood safety measure to reduce transfusion risks.
Under the BARDA contract, Cerus will receive initial funding of up to $30,750,939 to support activities related to a clinical trial to assess the safety and efficacy of Intercept RBCs compared to conventional RBCs in Puerto Rico, which has been impacted by the Zika virus epidemic. This funding also will support activities related to in vitro studies to facilitate potential pivotal Phase III clinical trials in the continental U.S.
In addition to the base period where BARDA has committed the initial funding, the five-year contract includes option periods that, if exercised by BARDA and completed, would bring the total non-dilutive funding opportunity to up to $180,509,914. The subsequent options would fund activities related to broader implementation in areas of Zika virus risk, clinical and regulatory development programs in support of licensing, and development, manufacturing and scale-up activities.
Cerus and its partners will be responsible for co-investing $14.5 million related to manufacturing. The BARDA contract also includes the possibility of funding the deployment of previously licensed Intercept-treated platelet and plasma components for use in Hawaii in the event of an active Zika outbreak.
Cerus was awarded Contract No. HHSO100201600009C.