CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that it has submitted
the third 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 platelets. The INTERCEPT platelet submission
was completed at the end of the second quarter as projected in Cerus’
regulatory timeline.
“We are extremely pleased to have met major US regulatory milestones
with the INTERCEPT plasma PMA currently under FDA review, and now, the
initiation of the review process for INTERCEPT platelets. FDA has
indicated that it has all the information needed to proceed with its PMA
filing review for INTERCEPT platelets.” said Carol Moore, Cerus’ senior
vice president of regulatory, quality and clinical affairs. “We are
committed to working with FDA in completing the application reviews.”
“In light of our recent regulatory progress in the US, Canada and
Mexico, we are excited about the prospect of accessing the North
American market,” said William 'Obi' Greenman, Cerus’ president and
chief executive officer. “We continue to focus our efforts on launch
preparation, including the expansion of our commercial team, launch
material preparation, and organizing key events. When we receive these
approval decisions, our commercial team plans to be ready.”
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood safety. 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 potential
approval by the FDA of the Company’s PMA submissions for the INTERCEPT
Blood System for plasma or for platelets and the success of the
Company’s launch preparedness efforts. 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 associated with the
commercialization and market acceptance of, and customer demand for, the
INTERCEPT Blood System; the uncertain and time-consuming regulatory
process, including the risks that the Company may be required to
complete additional clinical trials in order to obtain approval of its
PMA submissions for plasma or for platelets; that the Company may
otherwise encounter unanticipated difficulties complying with the
regulatory requirements related to the INTERCEPT Blood System for plasma
or for platelets or that the Company’s PMA submissions for plasma or for
platelets might not be approved by the FDA in a timely manner or at all;
that the Company may not have the resources to support multiple
regulatory submissions; 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-Q for the quarter ended March 31, 2014, filed with the SEC on May 12,
2014. 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