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.
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.