CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that additional options totaling $46.6 million have been exercised under its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
“The allocation of additional options, coupled with recent FDA feedback on the dossier of clinical data required for a possible future red cell PMA submission, confirm our next steps forward for INTERCEPT red blood cells (RBCs) in the U.S.,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “Importantly, funds have now been allocated to support our planned Phase III ReCePI study, which is designed to evaluate the efficacy and safety of INTERCEPT RBCs to treat acute anemia in cardiovascular surgery patients.”
In addition to funding the proposed Phase III ReCePI study, the newly exercised options include support for a clinical study in the UK to evaluate the efficacy and safety of INTERCEPT red blood cells in patients undergoing exchange transfusion for sickle cell disease. This tranche of funding also allocates funds toward the development of the INTERCEPT RBC System design to enable expanded use and manufacturing scale up of key components.
The total value of the full five-year contract is up to $186 million, subject to funding of additional contract options, and provides non-dilutive funding to support a comprehensive development program for the pathogen reduction of RBC components in the U.S. Funding allocated to date, including the latest tranche, totals $88.4 million. Previously allocated funds are already supporting the Phase III RedeS trial to assess the safety and efficacy of INTERCEPT RBCs compared to conventional RBCs in regions at risk for the Zika virus.
This contract is being funded in whole or in part with federal funds from the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. HHSO100201600009C.
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. 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, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development. See www.cerus.com for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products and prospects, including statements concerning Cerus’ receipt of funding under the recently exercised funding options in the BARDA contract; Cerus’ expectations with respect to activities that will or may be funded under such recently exercised options and the sufficiency of that funding; and potential future clinical trial activity and regulatory submissions. Actual results could differ materially from these forward-looking statements as a result of certain factors, including without limitation: risks associated with the uncertain nature of funding over which Cerus has no control as well as actions of Congress and governmental agencies which may adversely affect the availability of funding under the contract and/or exercise of any potential subsequent option periods, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be delayed or halted; the uncertain and time-consuming research and development processes that may be necessary prior to the commencement of a Phase III clinical trial; the risks that Cerus may be unable to meet FDA requirements to commence any Phase III clinical studies; the time-consuming clinical trials and regulatory processes that must be completed to obtain regulatory approval of the red blood cell system in a timely manner or at all; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus‘ Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.