Cerus Corporation

01/21/2020 | Press release | Distributed by Public on 01/21/2020 07:55

French Hemovigilance Report Highlights Safety and Effectiveness of INTERCEPT Platelets During First Full Year of 100% Production and Routine Use

CONCORD, Calif.--(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

Source: Cerus Corporation