CONCORD, Calif.--()--Cerus Corporation (NASDAQ: CERS) announced today that Ilex, Cerus’ exclusive distributor for South Africa, has submitted a regulatory dossier for approval of the INTERCEPT Blood System for platelets under a fast track designation by the South African Medicines Control Council (MCC).
“We believe the fast track designation reflects the high priority accorded to transfusion safety measures like pathogen inactivation by the MCC”
“We believe the fast track designation reflects the high priority accorded to transfusion safety measures like pathogen inactivation by the MCC,” said Carol Moore, Cerus’ vice president, regulatory affairs, quality and clinical. “We understand the review process can take at least 12 months to complete, and look forward to supporting Ilex through the potential approval and future South African launch of INTERCEPT platelets.”
“South Africa has unique challenges to transfusion safety, including both emerging pathogens and an high prevalence of HIV in the donor pool. We see INTERCEPT as the next logical step to safeguard patients from transfusion-transmitted infections,” said Dr. Moshe Benshaul, chief executive officer of Ilex.
Under an agreement signed last year, Ilex is responsible for sales, deployment and support of the INTERCEPT platelet and plasma systems in South Africa and Israel. Approximately 40,000 platelet units and 100,000 plasma units are collected annually in South Africa.
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate 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. 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 timing of the review process by the MCC, the potential approval and potential future launch of the INTERCEPT Blood System for platelets in South Africa, and the potential benefits of the INTERCEPT Blood System to safeguard patients from transfusion-transmitted infections. 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, the risk that the review by the MCC may take longer than expected or that the MCC may not approve the INTERCEPT Blood System, risks associated with successfully launching a commercial product in new territories and the related potential demand for the INTERCEPT Blood System, risks associated with Cerus’ dependence on third-party distributors and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended June 30, 2012, filed with the SEC on August 8, 2012. 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.