CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that The Community
Blood Center (CBC) of Appleton, Wisconsin received approval by the U.S.
Food and Drug Administration (FDA) on their Biologics License
Application (BLA) requesting allowance of interstate distribution of
platelets that have been pathogen-reduced with the INTERCEPT Blood
System.
“CBC Appleton’s BLA approval is another important step in our mission to
make INTERCEPT the standard of care for transfused blood components,”
said William “Obi” Greenman, Cerus’ president and chief executive
officer. “With the BLA approval, CBC can now ship INTERCEPT-treated
platelets across state lines thereby increasing patient access to safe
and effective blood products.”
CBC is the fourth blood center to receive BLA approval. Six additional
blood centers are awaiting BLA approvals.
“Our BLA approval will enable us to supply INTERCEPT-treated platelets
for patient care within Wisconsin and throughout the United States,”
commented John Hagins, CBC’s president and chief executive officer.
“Through increased availability of pathogen reduced products, we can
help our hospitals protect patients from transfusion-transmitted
infections, including from bacteria and newly emerging pathogens.”
The Biologics License Application is a common procedure for blood
centers to request permission from 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.
ABOUT THE COMMUNITY BLOOD CENTER
Community Blood Center provides 100% of the blood given to patients at 17
Wisconsin and Michigan hospitals. CBC operates neighborhood-donor
centers in Appleton, Oshkosh, Little Chute, and Woodruff. Last year,
volunteer donors gave more than 50,000 blood
donations with CBC. Since 1955, CBC has worked with blood donors to
provide a steady, reliable blood supply for hospitals. Today, the blood
center remains a nonprofit, independent organization committed to
serving hospital patients. See www.communityblood.org
for more information.
ABOUT CERUS
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.
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Cerus Corporation
Tim Lee, 925-288-6137
Investor Relations
Director
Source: Cerus Corporation