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 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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Last updated on: 13/10/2016
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