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    Cerus Announces First U.S. Blood Center Customer Submits Biologics License Application to the FDA to Allow for Interstate Export of INTERCEPT Platelet Components

    Chelsea Pratt
    Oct. 13, 2016 07:44AM PST
    Medical Device Investing

    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.
    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.

    intercept blood systemfda approvalseuropeunited statesfood and drug administration
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