CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that it has submitted
its Medical Device license application to Health Canada for review of
the INTERCEPT Blood system for plasma. This follows an agreement reached
with Health Canada in November of last year to pursue regulatory
submissions for both INTERCEPT platelets and plasma. Cerus plans to file
its regulatory submission for platelets in the second quarter of 2014.
“The parallel regulatory submissions in the US and Canada have enabled
us to be efficient in our filings by leveraging common elements in both
submissions, including the existing dossier of clinical and routine use
data accumulated over ten years in Europe,” said Carol Moore, Cerus’
senior vice president of regulatory, quality and clinical affairs. “We
are excited about our continued regulatory progress in North America,
and look forward to the subsequent regulatory filing for INTERCEPT
platelets to Health Canada.”
Canada is supported by two blood services, Hema Quebec for the province
of Quebec and Canadian Blood Services for the remainder of the country.
Hema Quebec and Canadian Blood Services produce approximately 55,000 and
70,000 units of plasma for transfusion per year, respectively.
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 regulatory
submission to Health Canada for INTERCEPT platelets, 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 uncertain and time-consuming
regulatory process, the fact that Cerus may encounter unanticipated
difficulties complying with the regulatory requirements for a Canadian
product approval, the fact that Cerus may not have the resources to
support multiple regulatory submissions, 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 quarter ended
December 31, 2013, filed with the SEC on March 7, 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