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