Amendment provides an incremental $15 million in funding bringing the
total potential contract value to more than $200 million
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq: CERS) today announced an amendment to the
Company’s contract with the Biomedical Advanced Research and Development
Authority (BARDA). The expansion of the agreement provides an additional
$15 million in funding for supplementary support of both the ReCePI
acute anemia clinical trial and SCient chronic anemia clinical trial.
“BARDA is an important partner in our mission to establish INTERCEPT as
the standard of care for all transfused blood components globally,” said
Dr. Richard Benjamin, Cerus’ chief medical officer. “Our collaboration
with BARDA provides Cerus with the support and non-dilutive funding
anticipated to complete the clinical development, regulatory submission,
and commercial scale-up activities for INTERCEPT red blood cells (RBCs)
in the U.S.”
The total potential value of the amended contract with BARDA is $201
million. Funding allocated to date now totals $103 million in support of
clinical development activities, including two U.S. Phase 3 studies, and
the further development of the INTERCEPT system design in order to
enable expanded use and manufacturing scale up of key components.
ReCePI is a Phase 3 study designed to evaluate the efficacy and safety
of INTERCEPT treated RBCs in patients requiring transfusion for acute
blood loss during complex cardiac surgery. A total of 600 patients are
expected to be enrolled in up to 20 participating sites in the U.S.
Patients will be randomized on a 1:1 basis with patients in the control
arm transfused with conventional RBCs. The primary efficacy endpoint is
the proportion of patients experiencing acute kidney injury as an
assessment of RBC efficacy in providing tissue oxygenation, measured as
an increase in serum creatinine compared to pre-surgery, baseline levels
within 48 hours after the surgery. Enrollment is expected to begin this
summer.
SCient is a Phase 2, randomized study designed to evaluate the efficacy
and safety of INTERCEPT treated RBCs in patients undergoing exchange
transfusion for sickle cell disease. The study will be conducted in the
United Kingdom.
BARDA is part of the Office of the Assistant Secretary for Preparedness
and Response within the U.S. Department of Health and Human Services.
This project has been 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.
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 the 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,
prospects and expected results, including statements concerning Cerus’
mission to establish INTERCEPT as the global standard of care for all
transfused blood components; Cerus’ expectations with respect to receipt
of 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; and potential future clinical trial
activity and regulatory submissions; and other statements that are not
historical facts. Actual results could differ materially from these
forward-looking statements as a result of certain factors, including,
without limitation: risks associated with; the uncertain and
time-consuming development and regulatory process, including the risks
that anticipated clinical trials of the INTERCEPT Blood System may not
be initiated on the anticipated timing or at all, or if initiated, may
be extended, delayed, suspended or terminated, including as result of
safety concerns; 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 Cerus’ BARDA agreement 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; risks related to the uncertain and
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; risks related to future opportunities and
plans, including the uncertainty of Cerus’ future capital requirements
and its future revenues and other financial performance and results, as
well as 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, 2018, filed with the SEC on May 8, 2018.
Cerus disclaims any obligation or undertaking to update or revise any
forward-looking statements contained in this press release.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180516006505/en/
Cerus Corporation
Tim Lee, 925-288-6137
Investor Relations
Director
Source: Cerus Corporation