French Hemovigilance Report Highlights Safety & Effectiveness of INTERCEPT Platelets During First Full Year of 100% Productio...
January 21 2020 - 8:30AM
Business Wire
Cerus Corporation (Nasdaq:CERS) is pleased to announce the
recent publication of the 16th Annual Hemovigilance report by the
French National Agency for Medicines and Health Products (ANSM)
which oversees the safety of medicine and other health products.
The report highlights the safety and effectiveness of INTERCEPT
platelets during the first full year of routine use.
“The new hemovigilance data published by ANSM underscores the
clinical utility and the safety benefits conferred by the use of
the INTERCEPT Blood Systems for platelets,” said William ‘Obi’
Greenman, Cerus’ president and chief executive officer. “We are
proud that every single patient receiving a platelet transfusion in
France today is benefitting from our pathogen-reduction
technology.”
Key highlights from the report include:
- 320,613 units of platelets were transfused in France and its
territories during 2018, of which 320,235 (99.9%) were INTERCEPT
treated
- Zero cases of bacterial infections by platelet transfusion in
2018 compared to 15 cases in the prior 5 years (2013-2017)
- Zero cases of arbovirus (Zika/Chikungunya/Dengue) transmissions
by platelet transfusion
- A discrete, but not statistically significant reduction in both
allergic transfusion reactions and overall platelet transfusion
refractoriness with INTERCEPT platelets
- The use of pathogen reduction replaced gamma irradiation of
platelets and CMV testing
“The French Hemovigilance system is the most robust surveillance
system for transfusion safety in the world and it is encouraging to
observe that the INTERCEPT system provided the expected safeguard
to the French platelet supply during its first full year in routine
use at 100%,” said Dr. Richard Benjamin, Cerus’ chief medical
officer. “We believe this large new data set documenting the French
experience will provide further confidence to U.S. blood centers
and hospitals as they anticipate increasing use of INTERCEPT in
order to comply with the FDA’s Guidance Document on platelet
bacterial safety.”
The French national hemovigilance system was created by law in
1993 to detect and reduce the risk of adverse events related to
blood transfusions. The national system is a collaboration between
ANSM, the Regional Hemovigilance and Blood Safety Coordinators, the
French National Blood Service (EFS), the Armed Forces Blood
Transfusion Center (CTSA), and the French Public Health Agency.
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.
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 anticipated increasing customer demand 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
associated with Cerus’ lack of commercialization experience in the
United States 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 for platelets and plasma 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; the
uncertain and time-consuming development and regulatory process,
including the risks (a) that Cerus may be unable to comply with the
FDA’s post-approval requirements for the INTERCEPT platelet and
plasma systems, including by successfully completing required
post-approval studies, which could result in a loss of U.S.
marketing approval for the INTERCEPT platelet and/or plasma
systems, (b) related to Cerus’ ability to expand the label claims
and product configurations for the INTERCEPT platelet and plasma
systems in the United States, (c) that Cerus may be unable to
submit anticipated regulatory submissions in a timely manner or at
all and even if submitted, such submissions may not be accepted or
approved in a timely manner or all, (d) that applicable regulatory
authorities may disagree with Cerus’ interpretations of the data
from its clinical studies and/or may otherwise determine not to
approve Cerus’ regulatory submissions in a timely manner or at all,
and (e) even if Cerus’ regulatory submissions are approved, Cerus
may not receive label claims for all requested indications or for
indications with the highest unmet need or market acceptance; risks
related to adverse market and economic conditions; risks related to
future opportunities and plans, 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, 2019, filed with the SEC on October 30, 2019.
Cerus disclaims any obligation or undertaking to update or revise
any forward-looking statements contained in this press release.
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Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
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