Cerus Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for
Cerus Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for INTERCEPT Plasma
CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (NAS: CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval application (PMA) shell for review of the INTERCEPT Blood System for plasma. A PMA shell is an outline of the application process that defines the structure, content and timing of each module. FDA and the applicant need to agree on a shell prior to initiation of a modular PMA submission.
"Our PMA shell proposal was designed to leverage our existing regulatory dossier from European approvals and to begin the INTERCEPT plasma regulatory submission in Q1 of 2013," said Carol Moore, Cerus' vice president, regulatory affairs, quality and clinical. "FDA's agreement with our proposal means that we can target completing all four modules in 2013, putting us in a position to receive U.S. approval as early as 2014."
A modular PMA review process is based on submission of a compilation of sections or "modules" at 90-day intervals that together become a complete PMA. Under a modular approach, FDA is able to review each module separately, allowing the applicant to receive timely feedback and potentially resolve deficiencies earlier in the review process than would be expected with a traditional PMA application.
Cerus recently announced its intention to pursue a modular PMA submission after dialogue with the FDA indicated that the company could proceed with an application for multiple indications of plasma use, not just the thrombotic thrombocytopenic purpura (TTP) indication for which Cerus received orphan drug designation last year.
"Approval in the U.S. would be a pivotal achievement for us," said Cerus' president and CEO, William 'Obi' Greenman. "We have already begun launch planning activities for the U.S., benefiting from our many years of experience in Europe commercializing the INTERCEPT Blood System and working with INTERCEPT plasma customers."
The INTERCEPT Blood System for plasma received a CE mark in 2006, with subsequent national approvals in France, Germany and Switzerland. In clinical trials in patients with acquired coagulopathies, congenital coagulopathies and TTP, INTERCEPT plasma was well tolerated and demonstrated therapeutic efficacy comparable to conventional plasma. Data have also been collected in Phase IV studies and hemovigilance programs that support the safety and efficacy of INTERCEPT plasma in routine use across a broad variety of indications. INTERCEPT plasma is currently used by customers in Belgium, France, Germany, Italy, Kazakhstan, Russia and Spain.
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases 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 enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate 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 is in discussion with FDA to define the additional clinical data required for a regulatory submission for the INTERCEPT Blood System for platelets. The INTERCEPT Blood System for red blood cells 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 timing of the PMA review process by the FDA, the potential approval and future launch of the INTERCEPT Blood System for plasma in the U.S., and the potential benefits from applying our commercialization experience to a potential launch in the U.S. 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, the risk that the review by the FDA may take longer than expected, that the FDA could require additional data to support potential approval, or that the FDA may not approve the INTERCEPT Blood System for plasma, risks associated with successfully launching a commercial product in new territories and the related potential demand for the INTERCEPT Blood System and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended September 30, 2012, filed with the SEC on November 8, 2012. 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
KEYWORDS: United States North America California
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