CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq:CERS) announced today that the American Red
Cross has received approval by the U.S. Food and Drug Administration
(FDA) for their first biologics license application (BLA) for interstate
distribution of platelets that have been pathogen-reduced with INTERCEPT
Blood Systems.
“This BLA approval is a key milestone for Cerus and the American Red
Cross,” said Vivek Jayaraman, Cerus’ chief commercial officer. “Given
the Red Cross’ extensive customer base across the United States, the
ability to ship product interstate is critical to reaching hospitals
interested in adopting INTERCEPT treated platelets and ensuring patients
have access to safer blood components.”
“With 13 Red Cross production sites now producing INTERCEPT platelets,
this first BLA approval is an important step toward broader distribution
of pathogen reduced platelets,” said Chris Hrouda, president, Biomedical
Services for the American Red Cross. “We believe, this approval should
help streamline the process for subsequent BLA submissions for our other
manufacturing sites. As we receive additional approvals and increase
production of INTERCEPT-treated components, we will be able to provide
INTERCEPT-treated components to hospitals and patients in regions we are
currently unable to reach.”
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.
ABOUT THE AMERICAN RED CROSS
The American Red Cross shelters, feeds and provides emotional support to
victims of disasters; supplies about 40 percent of the nation's blood;
teaches skills that save lives; provides international humanitarian aid;
and supports military members and their families. The Red Cross is a
not-for-profit organization that depends on volunteers and the
generosity of the American public to perform its mission. For more
information, please visit redcross.org or cruzrojaamericana.org, or
visit us on Twitter at @RedCross.
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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Tim Lee – Investor Relations Director
Cerus Corporation
925-288-6137
Source: Cerus Corporation