CONCORD, Calif.--(EON: Enhanced Online News)--Cerus Corporation (NASDAQ: CERS) announced today that additional options totaling $10,825,555 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 newly exercised options include funding for in vitro pathogen inactivation and red blood cell (RBC) function studies to support FDA licensure, as well as the manufacturing of clinical trial materials needed for a Phase III trial in the continental United States.
“We are working closely with the FDA to reach an agreement on the protocol design for our Phase III trial, and this additional funding ensures that we can begin preparing the necessary clinical trials materials to move forward quickly upon such agreement.”
“The exercise of these additional options reflects the substantial progress our team has made in just a few short months since initiating activities related to this important contract with BARDA,” said Dr. Laurence Corash, Cerus’ chief scientific officer. “We are working closely with the FDA to reach an agreement on the protocol design for our Phase III trial, and this additional funding ensures that we can begin preparing the necessary clinical trials materials to move forward quickly upon such agreement.”
The total value of the full five-year contract has also increased to be worth up to $185 million in non-dilutive funding to Cerus to support its development program for pathogen reduction of RBC components in the U.S., including the potential to fund activities related to anticipated Phase III clinical studies and the required manufacturing and development activities needed to pursue a potential U.S. commercial launch.
As part of the agreement, base period funding totaling $31 million was previously allocated to support a clinical trial known as “RedeS” to assess the safety and efficacy of INTERCEPT RBCs compared to conventional RBCs in regions heavily impacted by the Zika virus epidemic including Puerto Rico, as well as activities related to in vitro studies to facilitate potential pivotal Phase III clinical trials in the continental U.S. The base period funding also can be used to extend the RedeS trial to Florida which has now become epidemic for Zika.
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. Pathogen reduction treatment of blood components offers the opportunity to improve national emergency preparedness for epidemic and endemic blood-borne pathogens such as Zika, dengue, and chikungunya, and to further protect patients undergoing routine care, especially in regions with rapidly emerging epidemic pathogens.
INTERCEPT pathogen reduction technology for platelets and plasma has been used in Europe for over a decade 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 2014, and the system is now in routine use at a number of blood centers across the United States.
Cerus reported positive results from a European Phase III clinical trial in 2015 of the INTERCEPT Blood System for red blood cells and plans to submit an application for CE Mark registration for European approval.
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 manufacturing scale-up activities, in vitro studies and preparedness for a Phase III clinical trial in the continental U.S. 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 BARDA’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 BARDA contract and/or BARDA’s 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; 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 September 30, 2016, filed with the SEC on November 4, 2016. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.