Cerus Corporation Announces FDA Approval for INTERCEPT Blood System for Plasma with Alternate Plastic Disposable Kits
May 04 2020 - 8:30AM
Business Wire
Cerus Corporation (Nasdaq:CERS) announced today FDA regulatory
approval for manufacture of INTERCEPT plasma with a new,
alternative plastic disposable kit. The planned conversion to these
new kits is part of the Company’s ongoing strategy to enhance its
global supply chain integrity that was initiated several years
ago.
“The FDA approval for the new INTERCEPT plasma kit is
significant as it is a prerequisite for our planned PMA-S
submission for pathogen reduced cryoprecipitate, expected this
quarter. In addition, the approval is important given the renewed
interest in convalescent plasma as a promising treatment for those
afflicted with COVID-19,” said William “Obi” Greenman, Cerus’
president and chief executive officer. “The use of the INTERCEPT
system in the processing of COVID-19 convalescent plasma reduces
the risk of transfusion transmitted infections from known and
emerging pathogens and retains antibody titers.”
The International Society of Blood Transfusion Working Party on
Global Blood Safety indicated in a recently published document
titled “Points to consider in the preparation and transfusion of
COVID-19 convalescent plasma,” that following the plasma donation,
the use of a licensed pathogen technology is “highly desirable” to
reduce the risk of transfusion transmitted infections and alleviate
concerns about “possible superinfections with SARS-CoV-2”.
“The use of the INTERCEPT Blood System for plasma is a natural
extension for our U.S. customers who have already adopted INTERCEPT
platelets as the standard of care,” continued Greenman.
Based on the 2017 National Blood Collection and Utilization
Survey, approximately 3.2 million units of plasma are distributed
annually in the U.S. for transfusion.
The INTERCEPT Blood System for plasma is designed to pathogen
reduce a broad spectrum of viruses, bacteria, protozoa, and
contaminating donor leukocytes in plasma components to reduce the
risk of transfusion transmitted infections. It has demonstrated
robust inactivation of several members of the coronavirus family,
including SARS-1 COV and MERS CoV.
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.
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
therapeutic potential of convalescent plasma for COVID-19 patients;
the filing of a PMA-S submission for pathogen reduced
cryoprecipitate and the timing thereof; 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 related to the
uncertain and time-consuming development and regulatory process,
including the risks (a) that the INTERCEPT Blood System does not
have approved label claims for SARS-CoV-2 inactivation and may not
successfully inactivate SARS-CoV-2; (b) that convalescent plasma
therapies are unproven in treating, and may be ineffective in
treating, patients with COVID-19, (c) that Cerus may be unable to
submit its planned PMA supplement to the FDA for pathogen-reduced
cryoprecipitate in a timely manner or at all, and even if
submitted, such planned PMA supplement may not be accepted or
approved in a timely manner or at 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, including Cerus’
planned PMA supplement submission for pathogen-reduced
cryoprecipitate, in a timely manner or at all, and (e) that 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; as well as other risks
detailed in Cerus’ filings with the Securities and Exchange
Commission, including Cerus’ Annual Report on Form 10-K for the
year ended December 31, 2019, filed with the SEC on February 21,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200504005227/en/
Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
Cerus (NASDAQ:CERS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cerus (NASDAQ:CERS)
Historical Stock Chart
From Apr 2023 to Apr 2024