Cerus Corporation (Nasdaq:CERS) announced today it was awarded a five-year contract with the U.S. Food and Drug Administration (FDA) for the development of next-generation compounds to optimize pathogen reduction (PR) treatment of whole blood to reduce the risk of transfusion-transmitted infections. The contract value totals $11.1 million. This research is consistent with the FDA’s strategy for developing proactive, foundational interventions to ensure blood safety and availability1.
Given the possible benefits of whole blood transfusion2, pathogen reduced whole blood has the potential to fundamentally reshape the support of patients with massive hemorrhage.
“We appreciate the FDA’s support of Cerus’ research program for whole blood PR technology,” said Dr. Nina Mufti, program leader for both the Whole Blood and Red Blood Cell programs at Cerus. “A whole blood PR solution would complement Cerus’ portfolio of marketed pathogen reduction products for platelets and plasma, as well as its INTERCEPT Red Blood Cell (RBC) program that is in late-stage clinical development in the U.S.,” Mufti continued.
“This whole blood research effort could enable Cerus potentially to discover and develop the next generation of pathogen reduction technology to provide comprehensive safety solutions for transfusable blood components,” said Dr. Anil Bagri, vice president, research and pre-clinical development at Cerus. “We welcome FDA’s support in enabling Cerus to bring this vision to reality,” Bagri continued.
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Based in Concord, California, our employees are dedicated to deploying and supplying vital technologies and pathogen-protected blood components for blood centers, hospitals and ultimately patients who rely on safe blood. With the INTERCEPT Blood System, we are focused on protecting patients by delivering the full complement of reliable products and expertise for transfusion medicine. Cerus develops and markets the INTERCEPT Blood System and remains the only company in the blood transfusion space to earn both CE Mark and FDA approval for pathogen reduction of both platelet and plasma components. Cerus currently markets and sells the INTERCEPT Blood System 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. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
Forward Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to Cerus’ receipt of funding under the FDA contract; Cerus’ expectations with respect to activities that will or may be funded under the FDA contract and the sufficiency of that funding; Cerus’ expectations regarding the potential of a whole blood pathogen reduction solution; and the potential for a next generation pathogen reduction technology. Actual results could differ materially from these forward-looking statements as a result of certain factors, including without limitation: risks associated with on the uncertain nature of FDA’s 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 FDA contract; that FDA is entitled to terminate the FDA contract at any time for its convenience and is not otherwise obligated to provide continued funding beyond current year amounts from Congressionally approved annual appropriations; the uncertain and time-consuming development process; risks related to Cerus‘ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System, including a potential whole blood solution, is safe, effective and economical; other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus‘ Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 5, 2020. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus’ business and financial results, it may also have the effect of heightening many of the other risks and uncertainties described above. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.