Cerus Corp. Announces Five-Year FDA Contract for the Development of Next Generation Pathogen Reduction Technology to Treat Wh...
October 13 2020 - 8:30AM
Business Wire
Cerus Corporation (Nasdaq:CERS) announced today it was awarded a
five-year contract with the U.S. Food and Drug Administration (FDA)
for the development of next-generation compounds to optimize
pathogen reduction (PR) treatment of whole blood to reduce the risk
of transfusion-transmitted infections. The contract value totals
$11.1 million. This research is consistent with the FDA’s strategy
for developing proactive, foundational interventions to ensure
blood safety and availability1.
Given the possible benefits of whole blood transfusion2,
pathogen reduced whole blood has the potential to fundamentally
reshape the support of patients with massive hemorrhage.
“We appreciate the FDA’s support of Cerus’ research program for
whole blood PR technology,” said Dr. Nina Mufti, program leader for
both the Whole Blood and Red Blood Cell programs at Cerus. “A whole
blood PR solution would complement Cerus’ portfolio of marketed
pathogen reduction products for platelets and plasma, as well as
its INTERCEPT Red Blood Cell (RBC) program that is in late-stage
clinical development in the U.S.,” Mufti continued.
“This whole blood research effort could enable Cerus potentially
to discover and develop the next generation of pathogen reduction
technology to provide comprehensive safety solutions for
transfusable blood components,” said Dr. Anil Bagri, vice
president, research and pre-clinical development at Cerus. “We
welcome FDA’s support in enabling Cerus to bring this vision to
reality,” Bagri continued.
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https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-director-fdas-center-biologics-evaluation-and
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https://www.mayoclinic.org/medical-professionals/trauma/news/the-case-for-whole-blood-transfusions-in-massive-hemorrhage/mac-20431234
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System 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. For more information
about Cerus, visit www.cerus.com and follow us on LinkedIn.
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
relating to Cerus’ receipt of funding under the FDA contract;
Cerus’ expectations with respect to activities that will or may be
funded under the FDA contract and the sufficiency of that funding;
Cerus’ expectations regarding the potential of a whole blood
pathogen reduction solution; and the potential for a next
generation pathogen reduction technology. 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 FDA’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
FDA contract; that FDA is entitled to terminate the FDA 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 process; 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 a potential whole blood solution,
is safe, effective and economical; other risks detailed in Cerus’
filings with the Securities and Exchange Commission, including
Cerus‘ Quarterly Report on Form 10-Q for the quarter ended June 30,
2020, filed with the SEC on August 5, 2020. In addition, to the
extent that the COVID-19 pandemic adversely affects Cerus’ business
and financial results, it may also have the effect of heightening
many of the other risks and uncertainties described above. Cerus
disclaims any obligation or undertaking to update or revise any
forward-looking statements contained in this press release.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
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Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
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