American Red Cross Receives Biologics License Application Approval For INTERCEPT Platelets
December 10 2018 - 8:30AM
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 DirectorCerus
Corporation925-288-6137
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