Cerus Submits Final Module in the Premarket Approval (PMA) Application
Process for INTERCEPT Plasma
CONCORD, Calif. -- December 4, 2013
Cerus Corporation (NASDAQ: CERS) announcedtoday that it has submitted the
fourth and final module for its Premarket Approval (PMA) application to the
U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood
System for plasma.
As previously announced, Cerus filed the first of three modules for its
INTERCEPT Platelets PMA in September 2013, with submission of the last module
expected in March 2014.
“We are pleased to have filed the last module for INTERCEPT plasma with FDA on
schedule as planned,” said Carol Moore, Cerus’ senior vice president,
regulatory affairs, quality, and clinical. “With this important milestone as
well as continued progress with our regulatory submission for INTERCEPT
platelets, we remain on track for a U.S. review decision and launch of both
products as early as 2014.”
Cerus Corporation is a biomedical products company focused in the field of
blood safety. In in vitro studies, 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, potential regulatory approval and commercial availability of
the INTERCEPT Blood System in the United States, 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, the risk that
Cerus may encounter unanticipated difficulties complying with the prescribed
submission timing or other modular PMA requirements, or complying with the
regulatory requirements for a U.S. product approval, the risk that Cerus may
be required to conduct additional clinical development in support of its
regulatory submissions, and that if additional clinical development is
required it may require funding that Cerus does not have and that such
additional clinical development could significantly delay or preclude
regulatory approval, as well as 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, 2013, filed
with the SEC on November 1, 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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