Cerus Announces First U.S. Blood Center Customer Submits Biologics License Application to the FDA to Allow for Interstate Exp...
October 13 2016 - 8:30AM
Business Wire
Cerus Corporation (NASDAQ:CERS) announced today that The
Community Blood Center (CBC) of Appleton, Wisconsin has submitted
the first Biologics License Application (BLA) to the U.S. Food and
Drug Administration (FDA) requesting allowance for interstate
distribution of platelets that have been pathogen-reduced via the
INTERCEPT Blood System.
“We look forward to the FDA’s review of our application, and our
ability to supply INTERCEPT-treated platelets to hospital customers
outside of the state of Wisconsin,” commented John Hagins, CBC’s
president and chief executive officer.
“This first BLA submission is an important milestone for Cerus
and for CBC as it improves patient access to INTERCEPT components,”
said William “Obi” Greenman, Cerus’ president and chief executive
officer. “A number of our other customers are also nearing their
BLA submissions, moving us one step closer to supplying
pathogen-reduced platelets to hospitals in any state in the
U.S.”
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). The FDA has up to
12 months to review each BLA submission. 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 INTERCEPT BLOOD SYSTEM
The INTERCEPT Blood System is a pathogen reduction technology
designed to reduce the risk of transfusion-transmitted infections
by inactivating a broad range of pathogens such as viruses,
bacteria, parasites, and leukocytes that may be present in donated
blood. The INTERCEPT Blood System for platelets and plasma has been
used in Europe for over 10 years. Cerus also received FDA approvals
for the INTERCEPT Blood System for platelets and plasma in 2014,
and the system is now in routine use by a number of blood centers
across the United States, including the American Red Cross.
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 www.cerus.com for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus
Corporation.
ABOUT CBC
The Community Blood Center (CBC) was established in 1955 and
continues today as an independent nonprofit providing a safe and
reliable blood supply to hospitals in Northeast Wisconsin, the
Northwoods and upper Michigan. CBC has donor centers in Appleton,
Oshkosh, Little Chute and Woodruff, WI, plus hosts over 100 blood
drives every month. For more information on how you can donate
blood or host a blood drive, please visit www.communityblood.org or
call (800) 280-4102.
Forward Looking Statements
Except for the historical statements contained herein, this
press release contains forward-looking statements concerning Cerus’
products, prospects and expected results, including statements
concerning Cerus’ expectations regarding its customer’s ability to
obtain a BLA and ship products across state lines. Actual results
could differ materially from these forward-looking statements as a
result of certain factors, including, without limitation: risks
associated with the time-consuming regulatory process around
obtaining a BLA, 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 June 30, 2016,
filed with the SEC on August 5, 2016. Cerus disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20161013005260/en/
Cerus CorporationStacey Leanos, Associate Director, Investor
& Public RelationsLainie Corten, Vice President, Global
Marketing & Investor Relations925-288-6137 / ir@cerus.com
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