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

Rhea-AI Summary

Cerus (CERS) receives FDA approval for a 12-month shelf life extension for INTERCEPT Platelet Processing Sets, providing relief to customers and supply chains. The company aims to pursue further extensions beyond 12 months.

Insights

Biotech Industry Analyst

The FDA's approval for the extended shelf life of Cerus Corporation's INTERCEPT Platelet Processing Sets represents a significant operational milestone for the company. This decision directly impacts inventory management and supply chain efficiency, allowing for more flexible stock control and potentially reducing waste associated with expired products. From an industry standpoint, extended shelf life is a competitive advantage as it can improve customer satisfaction by ensuring a more reliable product supply.

In terms of financial implications, this could lead to improved cash flows due to better inventory turnover and decreased need for frequent replenishment orders. For stakeholders, the immediate applicability of the extension to existing inventories enhances the value of current assets and may positively influence the company's stock valuation in the short term. However, the long-term benefits would depend on the company's ability to leverage this approval to secure more contracts and expand market share.

Healthcare Supply Chain Expert

Extended shelf life for medical products like the INTERCEPT Platelet Processing Sets has a ripple effect throughout the healthcare supply chain. Hospitals and blood banks, which are key customers for Cerus, will likely experience reduced pressure on just-in-time inventory practices, allowing for better planning and potentially lower costs associated with emergency sourcing. This development could also translate to improved patient care due to decreased likelihood of supply shortages.

However, it's important to monitor how this extension affects the quality and safety of the platelet products over time. The FDA's approval suggests confidence in the product's stability, but healthcare providers will need to remain vigilant in tracking product performance. Additionally, Cerus Corporation's commitment to pursuing further extensions beyond 12 months indicates a proactive approach to research and development, which is essential in the ever-evolving biotech landscape.

Medical Research Analyst

The approval by the FDA is not only a testament to Cerus Corporation's regulatory strategy but also an endorsement of the quality of their INTERCEPT technology. The INTERCEPT system is designed to inactivate pathogens in platelets and plasma and the extended shelf life could suggest that the system's efficacy is maintained over a longer period than previously established.

It's important to understand that platelets are a perishable blood component with a traditionally short shelf life, making their availability a critical factor in medical procedures. The ability to extend the shelf life without compromising safety or efficacy could have considerable implications for transfusion medicine. This development may encourage further innovation in the field, as competitors will be motivated to match or exceed the new standard set by Cerus.

CONCORD, Calif.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240326078043/en/

Jessica Hanover – Vice President, Corporate Affairs

Cerus Corporation

925-288-6137

Source: Cerus Corporation

FAQ

What is the ticker symbol for Cerus ?

The ticker symbol for Cerus is CERS.

What did the FDA approve for Cerus ?

The FDA granted approval for a 12-month shelf life extension for INTERCEPT Platelet Processing Sets.

What was the previous shelf life for INTERCEPT Platelet Processing Sets?

The previous shelf life was six months, which has now been extended to 12 months.

Who is the chief operating officer of Cerus ?

Vivek Jayaraman is the chief operating officer of Cerus

What is Cerus aiming for regarding shelf life extension?

Cerus is aiming to pursue potential shelf life extensions beyond 12 months for INTERCEPT Platelet Processing Sets.