Cerus Announces First Biologics License Application Approval For U.S. Blood Center Customer
Published: Oct 05, 2017
Approval allows interstate shipment of INTERCEPT Platelets
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that Rhode Island Blood Center received approval by the U.S. Food and Drug Administration (FDA) on their Biologics License Application (BLA) requesting allowance for interstate distribution of platelets that have been pathogen-reduced with the INTERCEPT Blood System.
“The BLA approval is a key milestone for Cerus as it improves patient access to INTERCEPT Platelets. Rhode Island Blood Center now has the ability to ship INTERCEPT treated blood components across state lines to hospitals in regions where demand has exceeded supply due to various factors,” said William “Obi” Greenman, Cerus’ president and chief executive officer.
Seven additional blood centers have submitted BLAs.
“We can now offer INTERCEPT treated blood components not just in Rhode Island but throughout Southern New England and with our New York Blood Center network of affiliated blood centers,” said Lawrence Smith, chief executive officer of the Rhode Island Blood Center.
The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce (21 CFR 601.2). Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced. While some blood centers may distribute primarily in state, many U.S. blood centers have extensive interstate distribution.
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 http://www.cerus.com for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Lainie Corten, 925-288-6137
VP, Global Marketing & Investor Relations
Tim Lee, 925-288-6137
Investor Relations Director