CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS), a biomedical products company focused on improving blood transfusion safety, today announced an agreement 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, to support Cerus’ clinical development program for pathogen reduction of red blood cell (RBC) components, including access to funding that could support various activities, including funding studies necessary to support an FDA submission and accelerate commercial scale up to facilitate potential adoption by U.S. blood centers.
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.
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, a region impacted by the current 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.
The five-year contract with BARDA includes a base period with committed funding of up to $30,750,939, and subsequent option periods that, if exercised by BARDA and completed, would bring the total non-dilutive funding opportunity to up to $180,509,914 over the five-year contract period. If exercised by BARDA, the subsequent options would fund activities related to broader implementation in areas of Zika virus risk, clinical and regulatory development programs in support of licensure, and development, manufacturing and scale-up activities. Related to manufacturing, Cerus and its partners will be responsible for co-investment in the amount of $14.5 million. In addition, the BARDA contract also includes the possibility of funding the deployment of previously licensed INTERCEPT-treated platelet and plasma components for use in Hawaii to support self-sufficiency of that region in the event of an active Zika outbreak.
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.
“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,” said Dr. Laurence Corash, Cerus’ chief scientific officer. “We believe that T-cell inactivation levels with INTERCEPT provide the opportunity for future replacement of gamma irradiation, which would also align with the Department of Homeland Security’s initiative to eliminate nuclear source irradiators in the U.S. through the introduction of non-nuclear technologies.”
Both the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO) have issued guidance documents that acknowledge 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.
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.
This contract will be 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.
CONFERENCE CALL
Cerus will host a conference call and webcast on Monday, June 20, 2016 at 8:00 AM ET to discuss further details of the BARDA contract. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the company’s web site, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 37265772. The replay will be available approximately three hours after the call through July 4, 2016.
ABOUT CERUS
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 http://www.cerus.com for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward-Looking Statements
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 BARDA’s initial base period commitment; potential future option period exercises and commitments by BARDA and continued funding under the BARDA contract; Cerus’ expectations with respect to activities that will or may be funded under the BARDA contract and the sufficiency of that funding; the potential approval and future launch and adoption of the red blood cell system in the U.S.; potential future manufacturing scale-up activities and in vitro studies, as well as other activities contemplated under the BARDA contract; the ability of the INTERCEPT RBC system to replace gamma irradiation in the future; Cerus’ expectations regarding the potential of pathogen inactivation to improve national emergency preparedness; and Cerus’ plans to pursue CE Mark approval in Europe for the red blood cell system and the timing thereof. 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 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 total actual value of the BARDA contract to CERUS may be substantially less than anticipated; that BARDA is entitled to terminate the BARDA 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 and regulatory process, including that the FDA could require additional clinical data not contemplated by the BARDA contract to support potential Phase III clinical studies and/or regulatory approval and that if additional clinical development is required, it will require funding that Cerus does not currently have; the risks that Cerus may be unable to meet FDA requirements to commence any Phase III clinical studies and/or to submit the red blood cell system for approval, and even if a marketing application is submitted, Cerus may be unable to obtain FDA approval of the red blood cell system in a timely manner or at all; risks associated with the commercialization and market acceptance of, and customer demand for, the red blood cell system; risks associated with successfully launching a new commercial product; risks associated with Cerus‘ lack of commercialization experience in the United States; 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 the red blood cell system, is safe, effective and economical or that the red blood cell system is an effective alternative to gamma irradiation; risk that Cerus may be unable to file for CE Mark approval of the red blood cell system in Europe in the anticipated timeframe or at all, and even if filed, Cerus may be unable to obtain CE Mark approval of the red blood cell system in a timely manner or at all; 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, 2016, filed with the SEC on May 6, 2016. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
