Cerus Corporation Announces FDA Approval of Extended Shelf Life for INTERCEPT Platelet Processing Sets – Doubling Previous Shelf Life

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Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately.

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Retrieved on: 
Tuesday, March 26, 2024
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General Health, FDA, Medical Devices, Health, Cardiology, Corporation, CERS, Food, Cerus Corporation, Pharmaceutical industry
Geotags: 
UNITED STATES, NORTH AMERICA, CALIFORNIA
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CERUS, CERUS CORPORATION
Stock Symbol: 
NASDAQ:CERS
Summary
Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately.
  • This approval extends the set shelf life by six months from the existing six-month shelf life that took effect following a set component change last year.
  • All INTERCEPT Platelet Processing Sets in both customer and Cerus inventories are now eligible for this six-month extension.
  • This shelf-life extension applies to all sizes of INTERCEPT Platelet Processing Sets currently available in the U.S.
    “We are pleased with this successful and timely outcome to our regulatory filing with the FDA to re-establish a longer shelf life for INTERCEPT Platelet Processing Sets in the U.S.,” said Vivek Jayaraman, Cerus’ chief operating officer.


Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately. This approval extends the set shelf life by six months from the existing six-month shelf life that took effect following a set component change last year. All INTERCEPT Platelet Processing Sets in both customer and Cerus inventories are now eligible for this six-month extension. This shelf-life extension applies to all sizes of INTERCEPT Platelet Processing Sets currently available in the U.S.

“We are pleased with this successful and timely outcome to our regulatory filing with the FDA to re-establish a longer shelf life for INTERCEPT Platelet Processing Sets in the U.S.,” said Vivek Jayaraman, Cerus’ chief operating officer. “We expect that this extension will provide relief to our customers’ and our supply chains and will give customers the flexibility to balance inventory levels with current and future demand while reducing product expiration risk.”

The Company is continuing to generate additional data to pursue potential shelf life extension from the FDA beyond 12 months for the INTERCEPT Platelet Processing Sets.

ABOUT CERUS

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 the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. 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 Cerus’ products, prospects and expected results, including statements relating to: the impact of the six-month extension in shelf-life of the INTERCEPT Platelet Processing sets granted by FDA on our customers and supply chains; the potential for shelf life extension beyond 12 months by FDA for the INTERCEPT Platelet Processing sets; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain and time-consuming development and regulatory process, including: (a) the risk that Cerus may unable to generate and submit stability data to FDA to support the extension of the shelf life for the INTERCEPT Platelet Processing sets beyond 12 months in a timely manner or at all and (b) the risk that any changes to the INTERCEPT Platelet Processing sets may require additional aging and stability data in order to satisfy regulators and maintain historical label claims; risks related to product safety; 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 impact of macroeconomic developments, including the ongoing military conflicts in Ukraine and Israel, rising interest rates, inflation and 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 supply agreements with its third party suppliers; risks associated with Cerus’ need for additional funding; risks associated with macroeconomic developments, including ongoing military conflicts in Ukraine and Israel and the COVID-19 pandemic and resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus’ business operations; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC March 5, 2024. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

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