CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (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.
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.
- Health Canada
- Blood System