Health & Fitness
Health and Fitness
Health and Fitness
Wed, February 25, 2009
Tue, February 24, 2009 Cerus Announces Marketing Authorization Granted to Largest Region of German Red Cross
CONCORD, Calif.--([ BUSINESS WIRE ])--Cerus Corporation (NASDAQ: CERS) announced today that the German Red Cross in the Baden-Württemberg – Hessen region (DRK BWH), including Frankfurt, has been granted authorization by the Paul Ehrlich Institute (PEI) to market platelet components treated with the INTERCEPT Blood System. The marketing authorization covers platelets collected from single donors by apheresis. A broader marketing authorization covering pooled platelets using the buffy coat method of collection is pending. The DRK BWH is one of the large Red Cross Donor Services in Germany, collecting and processing approximately 25% of the blood supply in Germany.
"Cerus is pleased that the largest region of the German Red Cross can now implement the INTERCEPT platelet system," said Claes Glassell, president and CEO of Cerus Corporation. "By employing the INTERCEPT Blood System to inactivate pathogens found in donated platelet components, the DRK BWH can reduce the risk of transfusion transmitted infections from bacteria, viruses and parasites that may not be detected by diagnostic tests. This is a key regulatory development in the commercialization of the INTERCEPT Blood System in Germany."
As a leading reference center for transfusion medicine globally, the DRK BWH actively collaborates with transfusion medicine professionals from within Germany and around the world to share with them data on best practices in blood banking. Blood banks within the DRK BWH region process approximately 100,000 platelet units annually. Cerus announced on June 11, 2008, that a commercial supply agreement had been signed with the DRK BWH. Blood centers within the DRK BWH region have already received manufacturing approval from local Länder organizations. As contemplated in the supply agreement, the marketing authorization enables the DRK BWH to conduct a hemovigilance study prior to initiating commercial adoption of the INTERCEPT Blood System.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe and the Middle East. The company is also pursuing regulatory approvals in the United States and other countries. The INTERCEPT red blood cell system is currently in clinical development.
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 on the timing of a marketing authorization covering pooled platelet units collected using the buffy coat method, the conduct and outcome of a hemovigilance study,and the commercial implementation of the INTERCEPT Blood System by DRK Baden-Württemberg – Hessen under the supply agreement.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 the INTERCEPT Blood System, as well as other risks detailed in the company's filings with the Securities and Exchange Commission, including the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2007. No pathogen inactivation system has been shown to inactivate all pathogens.You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.The company does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
