Cerus Corporation announced today that The Community Blood Center of Appleton, Wisconsin has submitted the first Biologics License Application to the FDA requesting allowance for interstate distribution of platelets that have been pathogen-reduced via the INTERCEPT Blood System.
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.
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.
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
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.