Cerus Corporation (NASDAQ: CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval (PMA) application shell for review of the INTERCEPT Blood System for platelets. 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.
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 application. 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 currently has a PMA application with respect to its plasma system that is being submitted in four modules. The PMA application shell accepted by the FDA for the platelet system provides for three modular submissions, with the first module scheduled for submission at the end of September.
“Our platelet PMA shell proposal was designed to leverage synergies with our ongoing modular PMA submissions for our plasma system, allowing us to target completion of all three platelet modules by March 2014,” said Carol Moore, Cerus’ senior vice president, regulatory affairs, quality and clinical. “With the scheduled submission of the final INTERCEPT plasma module planned for the fourth quarter of this year, we have the possibility of receiving U.S. approvals for both products as soon as the second half of 2014.”
Cerus recently announced its intention to pursue a modular PMA submission for the INTERCEPT Blood System for platelets after dialogue with the FDA indicated that the company could proceed with an application based on the existing dossier of clinical and routine use data, along with a post-marketing study commitment, rather than being required to complete an additional Phase III clinical study.
“The platelet PMA submission timeline accepted by the FDA means we may be able to launch INTERCEPT platelets and plasma virtually simultaneously in the U.S.,” said Cerus' president and CEO, William ‘Obi’ Greenman. "Cerus is focused on succeeding at this goal, and maximizing the global impact we believe a U.S. market entry can create."
The INTERCEPT Blood System for platelets received a CE mark in 2002, with subsequent national approvals in France, Germany and Switzerland. In clinical trials, INTERCEPT platelet components were well tolerated and demonstrated therapeutic efficacy comparable to conventional plasma. Data have also been collected in Phase IV clinical studies and hemovigilance programs that support the safety and efficacy of INTERCEPT platelets in routine use across a broad variety of indications. INTERCEPT platelets are currently used by customers in Austria, Belgium, Chile, France, Italy, Kazakhstan, Kuwait, Norway, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Saudi Arabia, Turkey.
Cerus Corporation is a biomedical products company focused on enhancing 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 platelets and for plasma. 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, the timing of the PMA review process by the FDA, the potential approval and future launch of the INTERCEPT Blood System for plasma and platelets in the U.S., and the potential impact a U.S. approval will have globally. 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 commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, that the review by the FDA may take longer than expected, 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, that the FDA could require additional clinical data to support potential approval and that if additional clinical development is required, it will require funding that Cerus does not currently have, that the FDA may not approve the INTERCEPT Blood System for plasma or for platelets, risks associated with successfully launching a commercial product in new territories, the potential demand for the INTERCEPT Blood System , adverse market and economic conditions and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' annual report on Form 10-K for the year ended December 31, 2012, filed with the SEC on March 12, 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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