Press Release Details

Cerus and Baxter Submit CE Mark Application for European Approval of the Intercept Platelet System

January, 02 2001

Business Editors & Medical Writers

CONCORD, Calif. & DEERFIELD, Ill.--(BW HealthWire)--Jan. 2, 2001

Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation today announced that they have submitted a CE Mark application for approval to market the Intercept Platelet System in Europe. The system, which is being jointly developed by Cerus and Baxter Healthcare Corporation, is designed to inactivate viruses, bacteria, other pathogens and white blood cells in platelets intended for transfusion. If approved, the Intercept Platelet System will be the only system commercially available to enhance the safety of platelet transfusions through pathogen inactivation.

"This is a landmark achievement which was accomplished through a concerted effort between both Baxter and Cerus," said Stephen T. Isaacs, president and chief executive officer of Cerus. "We look forward to the approval of the Intercept Platelet System and working with Baxter to launch the first system to inactivate pathogens in platelets."

Harry M. Jansen Kraemer, Jr., chairman and chief executive officer of Baxter said, "We are very pleased with the significant progress of the Cerus and Baxter teams. This is a very important step toward enhancing the safety of platelet transfusions in Europe."

Approximately 1.3 million platelet transfusions are performed annually in Europe to prevent bleeding in a variety of patients, including those undergoing cancer therapy and surgical procedures. While donated platelets are generally tested for a limited number of specific pathogens, testing does not eliminate the risk of viral contamination, and most tests are not designed to screen for bacteria. Bacterial contamination is of particular concern as bacteria quickly grow in nutrient-rich platelet concentrates, which are stored at room temperature. Also, white blood cells from donated platelets can potentially result in graft-vs-host disease and other severe immune reactions in the transfusion recipient. The Intercept Platelet System is designed to inactivate viruses, bacteria, other pathogens and white blood cells in donated platelets prior to transfusion.


Cerus Corporation is developing medical systems and therapeutics based on the company's proprietary Helinx technology for inactivating disease-causing agents. Helinx is designed to target and lock DNA or RNA, and has the ability to prevent the replication of viruses, bacteria and other pathogens and to control cellular proliferation. The company's most advanced programs are focused on systems to enhance the safety of the world's blood supply. These Intercept Blood Systems, based on the Helinx technology, are designed to inactivate viruses, bacteria and other pathogens. The Concord, California-based biopharmaceutical company, in collaboration with its development and commercialization partner Baxter Healthcare Corporation, has submitted a CE Mark Application for marketing approval of the Intercept Platelet System in Europe. In addition, the company is conducting clinical trials of the Intercept Blood Systems in the United States: a Phase III trial for platelets, a Phase III trial for plasma and a Phase Ic trial for red blood cells.


Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International (NYSE:BAX). Baxter International, through its subsidiaries, is a global medical products and services company that provides critical therapies for people with life-threatening conditions. The company's products and services in bioscience (biopharmaceuticals and blood collection, separation and storage devices), medication delivery and renal therapy are used by health-care providers and their patients more than 100 countries.

Helinx is a trademark of Cerus Corporation

Intercept Blood System, Intercept Platelet System, Intercept Plasma System and Intercept Red Blood Cell System are trademarks of Baxter International, Inc.

Statements in this news release regarding product development, clinical development, regulatory activity and product potential are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the uncertainty of the timing and results of any clinical trials, action by regulatory authorities, the uncertainty of market acceptance of any products, competitive conditions, the uncertainty of future financing and other factors discussed in the companies' 1999 Annual Report on Form 10-K and Cerus' Prospectus dated November 1, 2000.

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