Cerus Corporation Announces FDA Approval for INTERCEPT Blood System for Cryoprecipitation
November 30 2020 - 8:30AM
Business Wire
Cerus Corporation (Nasdaq: CERS) today announced that the US
Food and Drug Administration (FDA) has granted approval of the
INTERCEPT Blood System for Cryoprecipitation. The system is used to
produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for
the treatment and control of bleeding, including massive
hemorrhage, associated with fibrinogen deficiency.
After thawing, Pathogen Reduced Cryoprecipitated Fibrinogen
Complex remains transfusion-ready at room temperature for up to 5
days, continuously available for administration over this extended
period. This product has been granted FDA Breakthrough Device
designation based on the potential to improve treatment of massive
hemorrhage, a life-threatening medical condition.
“FDA approval of the INTERCEPT Blood System for
Cryoprecipitation is an important step forward in our mission to
establish pathogen reduction as the standard of care for transfused
blood components globally,” said William ‘Obi’ Greenman, Cerus’
president and chief executive officer. “This is an important win
for hospitals, clinicians and patients and also represents a new
business model for Cerus. We plan to begin selling Pathogen Reduced
Cryoprecipitated Fibrinogen Complex in California, Texas, Louisiana
and Wisconsin in 2021, with expansion to national distribution in
2022 following anticipated approval of manufacturing site Biologics
License Applications.”
In addition to use for treatment and control of bleeding,
including massive hemorrhage, associated with fibrinogen
deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex is
also indicated for control of bleeding when recombinant and/or
specific virally inactivated preparations of factor XIII or von
Willebrand factor are not available, for second-line therapy for
von Willebrand disease, and for control of uremic bleeding after
other treatment modalities have failed.
“Fibrinogen plays a critical role in controlling bleeding, but
it has been difficult to provide quickly to massively bleeding
patients. The extended room temperature shelf life, after thawing,
of pathogen reduced cryoprecipitated fibrinogen complex allows it
to be prepared in advance, which is essential because immediate
availability will improve time to reversal of coagulopathy,” said
Dr. Philip C. Spinella, Professor of Pediatrics and Director of the
Critical Care Blood Research Program at Washington University in
St. Louis. “I am optimistic that pathogen reduced cryoprecipitated
fibrinogen complex will be a valuable tool to add to the tool box
of therapies that are needed to support damage control
resuscitation for patients with life threatening bleeding.”
In addition to the approval of Pathogen Reduced Cryoprecipitated
Fibrinogen Complex, a derivative product from its production,
called Pathogen Reduced Plasma, Cryoprecipitate Reduced, has also
been approved by the FDA for transfusion or therapeutic plasma
exchange in patients with thrombotic thrombocytopenic purpura
(TTP).
For more information about the INTERCEPT Blood System for
Cryoprecipitation, visit our product website at
http://www.intercept-cryoprecipitation.com.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Headquartered in Concord, California, the company
develops and supplies vital technologies and pathogen-protected
blood components to blood centers, hospitals, and ultimately
patients who rely on safe blood. The INTERCEPT Blood System for
platelets and plasma is available globally and remains the only
pathogen reduction system with both CE mark and FDA approval for
these two blood components. The INTERCEPT red blood cell system is
under regulatory review in Europe, and in late-stage clinical
development in the US. Also in the US, the INTERCEPT Blood System
for Cryoprecipitation is approved for production of Pathogen
Reduced Cryoprecipitated Fibrinogen Complex, a therapeutic product
for the treatment and control of bleeding associated with
fibrinogen deficiency, including massive hemorrhage. For more
information about Cerus, visit www.cerus.com and follow us on
LinkedIn.
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 the
advantages and therapeutic potential of the INTERCEPT Blood System
for Cryoprecipitation; the planned launch of the INTERCEPT Blood
System for Cryoprecipitation and the anticipated timing thereof;
the anticipated approval of manufacturing site Biologics License
Applications; Cerus’ mission to establish INTERCEPT pathogen
reduction as the standard of care for transfused blood components
globally; 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 commercialization and market
acceptance of, and customer demand for, the INTERCEPT Blood System,
including the risks that Cerus may not (a) effectively
commercialize the INTERCEPT Blood System for Cryoprecipitation, (b)
grow sales globally, including in its U.S. and European markets,
and/or realize expected revenue contribution resulting from its
U.S. and European market agreements, (c) realize meaningful and/or
increasing revenue contributions from U.S. customers in the near
term or at all, particularly since Cerus cannot guarantee the
volume or timing of commercial purchases, if any, that its U.S.
customers may make under Cerus’ commercial agreements with these
customers, and/or (d) realize any revenue contribution from its
pipeline product candidates, whether due to Cerus’ inability to
obtain regulatory approval of its pipeline product candidates, or
otherwise; risks associated with the ultimate duration and severity
of the COVID-19 pandemic and resulting global economic and
financial disruptions, and the current and potential future
negative impacts to Cerus’ business operations and financial
results such as the current and potential additional disruptions to
the U.S. and EMEA blood supply resulting from the evolving effects
of the COVID-19 pandemic; risks associated with Cerus’ lack of
commercialization experience with the INTERCEPT Blood System for
Cryoprecipitation and in the United States generally, and its
ability to develop and maintain an effective and qualified
U.S.-based commercial organization, as well as the resulting
uncertainty of its ability to achieve market acceptance of and
otherwise successfully commercialize the INTERCEPT Blood System in
the United States, including as a result of licensure requirements
that must be satisfied by U.S. customers prior to their engaging in
interstate transport of blood components processed using the
INTERCEPT Blood System; risks related to Fresenius Kabi’s efforts
to assure an uninterrupted supply of platelet additive solution
(PAS); risks related to how any future PAS supply disruption could
affect INTERCEPT’s acceptance in the marketplace; risks related to
how any future PAS supply disruption might affect current
commercial contracts; risks related to Cerus’ ability to
demonstrate to the transfusion medicine community and other health
care constituencies that pathogen reduction, including Pathogen
Reduced Cryoprecipitated Fibrinogen Complex for the treatment and
control of bleeding, and the INTERCEPT Blood System is safe,
effective and economical; risks related to the uncertain and
time-consuming development and regulatory process, including the
risks that (a) Cerus may be unable to comply with the FDA’s
post-approval requirements for the INTERCEPT Blood System,
including by successfully completing required post-approval
studies, which could result in a loss of U.S. marketing approval(s)
for the INTERCEPT Blood System, and (b) manufacturing site
Biologics License Applications necessary for Cerus to begin
distributing the INTERCEPT Blood System for Cryoprecipitation may
not be obtained in a timely manner or at all; risks associated with
Cerus’ lack of experience in marketing products directly to
hospitals and expertise complying with regulations governing
finished biologics; risks associated with the uncertain nature of
BARDA’s funding over which Cerus has no control; risks related to
product safety, including the risk that the septic platelet
transfusions may not be avoidable with the INTERCEPT Blood System;
risks related to adverse market and economic conditions, including
continued or more severe adverse fluctuations in foreign exchange
rates and/or continued or more severe weakening in economic
conditions resulting from the evolving effects of the COVID-19
pandemic or otherwise in the markets where Cerus currently sells
and is anticipated to sell its products; Cerus’ reliance on third
parties to market, sell, distribute and maintain its products;
Cerus’ ability to maintain an effective, secure manufacturing
supply chain, including the risks that (a) Cerus’ supply chain
could be negatively impacted as a result of the evolving effects of
the COVID-19 pandemic, (b) Cerus’ manufacturers could be unable to
comply with extensive FDA and foreign regulatory agency
requirements, and (c) Cerus may be unable to maintain its primary
kit manufacturing agreement and its other supply agreements with
its third party suppliers; Cerus’ ability to identify and obtain
additional partners to manufacture the INTERCEPT Blood System for
Cryoprecipitation; risks associated with Cerus’ ability to meet its
debt service obligations and its need for additional funding; the
impact of legislative or regulatory healthcare reforms that may
make it more difficult and costly for Cerus to produce, market and
distribute its products; risks related to future opportunities and
plans, including the uncertainty of Cerus’ future capital
requirements, 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 September 30,
2020, filed with the SEC on October 29, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201130005353/en/
Jessica Hanover – VP, Corporate Affairs Cerus Corporation
925-288-6137
Cerus (NASDAQ:CERS)
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