Cerus Announces Collaboration With Central California Blood Center To Manufacture Pathogen-Reduced Cryoprecipitate
Published: Jul 27, 2017
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today an agreement with the Central California Blood Center (CCBC) in which CCBC will manufacture pathogen-reduced cryoprecipitate (“cryo”) for the company. Cryoprecipitate is a blood product derived from blood plasma and contains coagulation factors VIII and XIII, fibrinogen, vWF, and fibronectin. Cryo is used in the control of bleeding associated with acquired fibrinogen deficiency. The current cryo products available today have a short post-thaw shelf life that limits their availability and contributes to significant wastage rates in the hospital setting.
“We are excited to be partnering with CCBC as we move forward on a new strategic program to expand our product offerings to include INTERCEPT cryoprecipitate,” noted William ‘Obi’ Greenman, Cerus’ president and CEO.
“Cryo is a natural extension to our current FDA-approved INTERCEPT Blood System for Plasma. Following approval of a proposed premarket approval (PMA) supplement, INTERCEPT Plasma may be further manufactured into cryoprecipitate, for which we plan to seek an extended 5-day post-thaw storage claim. Given today’s growing emphasis on, and use of, coagulation monitoring and fibrinogen supplementation in improving outcomes in acutely bleeding patients, an extended-storage cryo product can potentially address an opportunity that we believe represents a market larger than INTERCEPT Platelets in the U.S.,” Mr. Greenman continued.
“We are very pleased to be working with the Cerus team in developing a next-generation cryoprecipitate product. We recognize the unmet need in the clinical community for a cryo product with an extended post-thaw shelf life, given the challenges faced by hospital blood banks today in regard to the high wastage rates associated with the short expiry of conventional cryo,” noted Christopher Staub, incoming president and CEO of CCBC.
U.S. Commercial Opportunity
In the U.S., trauma is the leading cause of death in individuals under 44 years old. In addition, major hemorrhage is the most common preventable cause of death in trauma patients. Acute bleeding in other settings includes postpartum hemorrhage and cardiac surgery. Cryoprecipitate is recognized as an important source of fibrinogen replacement for these bleeding patients, and its clinical utility in treating major bleeding is evidenced by its inclusion in clinical statements such as the European guideline on management of major bleeding and coagulopathy, the American Society of Anesthesiologists (ASA) practice guidelines for perioperative blood management, and the Society of Cardiovascular Anesthesiologists (SCA) summary statement on blood conservation and transfusion in cardiac surgery.
Based on the 2015 AABB Blood Survey and the 2015 National Blood Collection & Utilization Survey, usage of conventional cryoprecipitate has been growing at double digit rates over the last five years. In addition, we believe the recent growth in next generation-coagulation monitoring systems is indicative of the expanding market opportunity for interventions to treat coagulopathy in cardiovascular surgery, trauma and maternal hemorrhage.
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma 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. See www.cerus.com for information about Cerus.
About Central California Blood Center
The Central California Blood Center provides blood and services to patients who receive care at 30 hospitals and their network of facilities in Fresno, Tulare, Madera, Kings and Mariposa Counties. 5,000 to 6,000 pints of blood must be collected per month to meet the needs of patients in our Central Valley community.
Except for the historical statements contained herein, this press release contains forward-looking statements relating to the potential submission of a PMA supplement to the FDA with respect to a pathogen-reduced, extended-storage cryo product, including the potential approval and future launch thereof, in the U.S., the intent to seen an indication for a pathogen-reduced, extended-storage cryo product and the potential market opportunity such a product will have in the U.S.. 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 a pathogen-reduced, extended-storage cryo product, that Cerus may encounter unanticipated difficulties in meeting the PMA supplement requirements, that the FDA could require additional clinical data to support potential approval and that if additional clinical development is required, it will require funding that Cerus does not currently have, that the FDA may not approve a pathogen-reduced cryo product or an extended storage indication, risks associated with successfully launching a new commercial product, the potential demand for a pathogen-reduced cryo product, adverse market and economic conditions, 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, 2017, filed with the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Lainie Corten - Vice President, Global Marketing & Investor Relations
Tim Lee - Investor Relations Director