CONCORD, Calif.--(BUSINESS WIRE)--
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.
“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.
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 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.
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Source: Cerus Corporation