CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today 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.”
ABOUT CERUS
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.
Source: Cerus Corporation