Cerus Announces Exercise of Additional BARDA Contract Options Totaling $46.6 million to Support INTERCEPT Red Blood Cell Syst...
May 09 2017 - 8:30AM
Business Wire
Newly released funding includes support for
ReCePI Phase III acute anemia study and commercial scale-up
activities
- The additional $46.6 million brings
Cerus' total allocation up to $88.4 million to date; current
allocations fund two of three expected Phase III studies for
possible future PMA submission
- ReCePI Phase III study protocol is
under FDA review, and RedeS Phase III study is open for
enrollment
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.
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 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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170509005572/en/
Cerus Investor Relations Contact:Lainie Corten, Vice President,
Global Marketing & Investor
Relations925-288-6137ir@cerus.com
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