CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that it has reached
agreement with Health Canada regarding a regulatory submission for the
INTERCEPT Blood System for platelets and plasma. Cerus plans to file
with Health Canada for both products in the first half of 2014. Health
Canada is the federal department in Canada that is responsible for
review and authorization of drug, device and health products. Canada is
supported by two blood services, Hema Quebec for the province of Quebec
and Canadian Blood Services for the remainder of the country.
“We are encouraged by our recent discussions with Health Canada,
particularly its interest in the future availability of pathogen
inactivated blood components and its willingness to accept Cerus’
regulatory filing for review,” said Carol Moore, Cerus’ senior vice
president of regulatory, quality and clinical affairs. “Combined with
our ongoing regulatory submissions to FDA in the United States, our
progress in Canada is another important step toward making pathogen
inactivation accessible throughout North America.”
The INTERCEPT Blood System for both platelets and plasma has received CE
mark, and both products have subsequently received national approvals in
France, Germany and Switzerland. Over 100 blood centers in 20 countries
are currently using the INTERCEPT Blood System, and both the platelet
and plasma systems are currently under regulatory review in the U.S.
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 potential regulatory approval and
commercial availability of the INTERCEPT Blood System in North America.
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 U.S. or
Canadian product approval, the fact 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 could significantly
delay or preclude regulatory approval, 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
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