Cerus Announces Collaboration with LifeSouth Community Blood Centers to Manufacture INTERCEPT® Fibrinogen Complex

Rhea-AI Summary

Cerus Corporation (NASDAQ: CERS) has partnered with LifeSouth Community Blood Centers to produce INTERCEPT® Fibrinogen Complex, expanding its initial commercial launch into Florida. This addition marks LifeSouth as the fifth production partner, enhancing distribution capabilities to over one-third of the U.S. population, which includes Florida's significant healthcare infrastructure. Anticipated BLA approvals are set to support a nationwide launch in 2022. The initiative aims to address the critical needs for blood management in transfusion medicine.

Positive

• Partnership with LifeSouth expands production and distribution of INTERCEPT Fibrinogen Complex.
• Initial enthusiastic market response indicates strong demand for the product.
• Access to Florida market enhances distribution to a state with over 30 trauma centers.

Negative

• Commercialization experience with INTERCEPT Fibrinogen Complex is limited.
• Risks associated with timely approval of Biologics License Applications may affect launch.
• Potential challenges in demonstrating product efficacy and cost-effectiveness to healthcare professionals.

Cerus Corporation (NASDAQ: CERS) announced today an agreement with LifeSouth Community Blood Centers (LifeSouth) to serve as a production partner for INTERCEPT^® Fibrinogen Complex, the company’s pathogen reduced cryoprecipitated fibrinogen complex product. LifeSouth is the fifth production partner for INTERCEPT Fibrinogen Complex, enabling the initial commercial launch of the product to expand into the state of Florida.

“We are delighted to add LifeSouth as a blood center manufacturing partner for INTERCEPT Fibrinogen Complex,” stated Elan Weiner, general manager of Cerus Therapeutics. “The initial market response has been enthusiastic and as we gear up for a nationwide launch in 2022 following anticipated BLA approvals, we are happy to be able to offer this product in Florida through our partnership. LifeSouth’s strong presence throughout the Southeast will help ensure we have the ability to easily deliver product to hospitals in the region,” Mr. Weiner continued.

As the third most populous state in the country, Florida is home to more than 30 Level 1, Level 2 and Pediatric trauma centers. Together with the other four states that are a part of the initial launch (California, Louisiana, Texas and Wisconsin), INTERCEPT Fibrinogen Complex will be available for use to nearly one-third of the U.S. population.

“We believe INTERCEPT Fibrinogen Complex is an exciting innovation in transfusion medicine, and we are pleased to partner with Cerus in the Florida market. Tools to help manage bleeding patients help fill a significant unmet need, and we are excited to contribute to making INTERCEPT Fibrinogen Complex available,” noted Kimberly E. Kinsell, president and chief executive officer of LifeSouth.

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 production of Pathogen Reduced Cryoprecipitated 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.

About LifeSouth Community Blood Centers

LifeSouth is a non-profit community blood center serving more than 100 hospitals in Alabama, Florida and Georgia. LifeSouth is committed to meeting the blood supply needs of hospitals and their patients by providing the highest quality blood components and services. To learn more, visit LifeSouth.org.

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^® Fibrinogen Complex; the planned launch of the INTERCEPT^® Fibrinogen Complex and the anticipated timing thereof; the anticipated approval of manufacturing site Biologics License Applications; 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, INTERCEPT^® Fibrinogen Complex; risks associated with Cerus’ lack of commercialization experience with INTERCEPT^® Fibrinogen Complex; risks related to the licensure requirements that must be satisfied by Cerus’ production partners prior to engaging in interstate transport of INTERCEPT^® Fibrinogen Complex; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that use of INTERCEPT^® Fibrinogen Complex for the treatment and control of bleeding is safe, effective and economical; risks that manufacturing site Biologics License Applications necessary for Cerus to begin distributing INTERCEPT^® Fibrinogen Complex 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, 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 March 31, 2021, filed with the SEC on May 4, 2021. 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.

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FAQ

What is the new partnership between Cerus Corporation and LifeSouth about?

Cerus Corporation has partnered with LifeSouth Community Blood Centers to produce INTERCEPT® Fibrinogen Complex, enhancing its distribution capabilities in Florida.

How will the partnership impact the availability of INTERCEPT Fibrinogen Complex?

The partnership will allow for the launch of INTERCEPT Fibrinogen Complex in Florida, increasing access to hospitals and trauma centers in the region.

When is the anticipated nationwide launch of INTERCEPT Fibrinogen Complex?

The nationwide launch of INTERCEPT Fibrinogen Complex is anticipated to take place in 2022, following expected Biologics License Approvals.

What are the potential risks mentioned in the press release regarding INTERCEPT Fibrinogen Complex?

The risks include challenges related to commercialization experience, timely approval of manufacturing licenses, and demonstrating the product's safety and effectiveness.

What regions are included in the initial launch of INTERCEPT Fibrinogen Complex?

The initial launch will include states such as California, Louisiana, Texas, Wisconsin, and Florida.