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.
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.