Cerus Corporation (NASDAQ:CERS) announced today that it has submitted the first of three modules for its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood System for platelets.
The PMA application shell for the platelet system, accepted by the FDA in April, provides for three modular submissions. This enables FDA to review each module separately, and allows the applicant to receive timely feedback to resolve possible deficiencies earlier in the review process when compared to a traditional PMA application.
In addition to the PMA for platelets, as of August 30, 2013, Cerus submitted to FDA the third of four modules for its modular PMA application for review of the INTERCEPT Blood System for plasma.
“We are on-target in meeting predicted timelines with respect to our PMA submissions,” said Carol Moore, Cerus’ senior vice president, regulatory affairs, quality and clinical. “The second and third modules for platelets are scheduled for submission at the end of December 2013 and March 2014, respectively, and the last plasma module is scheduled for November 2013.”
Cerus Corporation is a biomedical products company focused in the field of blood safety. The company’s INTERCEPT Blood System has been demonstrated to inactivate a broad range of viruses, bacteria and parasites that may be present in donated blood, including established threats such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Cerus is seeking regulatory approval of the INTERCEPT Blood System for plasma and platelets. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the submission of PMA modules to the FDA, including the timing thereof. These forward-looking statements are based upon Cerus’ current expectations.Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks related to the that Cerus may encounter unanticipated difficulties complying with the prescribed submission timing or other modular PMA requirements related to the INTERCEPT Blood System for plasma or for platelets and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' annual report on Form 10-Q for the quarter ended June 30, 2013, filed with the SEC on August 2, 2013. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Cerus does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
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