Cerus Announces Agreement with Health Canada for Regulatory Submission of the INTERCEPT Blood System for Platelets and Plasma

  Cerus Announces Agreement with Health Canada for Regulatory Submission of
  the INTERCEPT Blood System for Platelets and Plasma

Business Wire

CONCORD, Calif. -- November 6, 2013

Cerus Corporation (NASDAQ: CERS) announcedtoday 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.

Contact:

Cerus Corporation
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
 
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