Baxter Healthcare SA

INTERCEPT Blood System Received TÜV Approval for Storage of Platelets up to 7 Days

    Munich, Germany (ots/PRNewswire) -

    - Longer Storage Period Makes Platelets More Readily Available to European Transfusion Blood Centers

    European subsidiaries of Baxter International Inc. (NYSE: BAX) and Cerus Corporation (NASDAQ: CERS) today announced that they have received CE Mark Certification from TÜV Product Service GmbH extending the storage period for platelets treated with their INTERCEPT Platelet System from five to seven days. TÜV is an internationally recognized compliance organisation.

    "This is a major achievement for the INTERCEPT Blood System that represents an important step forward for transfusion blood centers all over Europe. Due to the extension of platelet shelf life, transfusion centers will now be able to store platelets up to seven days and have them more readily available for transfusion," said Jocelyne Flament, Medical Director Baxter.

    In addition, the INTERCEPT Blood System provides enhanced patient safety by reducing the risk of transfusion-transmitted diseases through blood transfusions.

    Longer and quicker availability of platelets

    The extended shelf life up to seven days allows transfusion centers in Europe to store platelets longer, enabling them to reduce products discards and improve inventory management, as platelets are available to transfusion patients for up to two more days.

    Furthermore, the INTERCEPT Blood System also allows for earlier availability of platelet products. Indeed, the method used by bacterial testing systems needs up to 24 hours for sampling and 24 to 36 hours for detection process, which means results are generally only available 2 days after collection at the earliest. This reduces the actual availability of the platelets to two to three days. Platelets that have been treated with the INTERCEPT Blood System are available immediately after the inactivation process. Therefore, with the 7-day approval, the actual shelf-life of Intercept Platelets will be 6 to 7 days depending upon when the process occurs.

    Robust inactivation

    With the INTERCEPT Blood System, no additional sampling steps are required. Bacterial detection systems can have limitations, including possible sampling errors, long incubation times before certain pathogens can be identified and are limited to bacterial detection. In addition, tests have indicated the possibility of false-negative results that can lead to fatal bacterial sepsis, and false-positive results which can cause discards of otherwise acceptable platelet products and increased cost[1].

    "We are pleased to make the Intercept Blood System for Platelets even more useful to the blood centers in extending platelet shelf life and reducing the risk of recalls associated with culture positive products," says Larry Corash, vice president and chief medical officer, Cerus.

    Enhanced patient safety

    The INTERCEPT Blood System is designed to protect patients by reducing the risk of transfusion-transmitted diseases. It goes beyond current blood safety measures by effectively inactivating a broad range of pathogens, including viruses, bacteria, parasites and leukocytes that can be found in platelets. Due to its specific inactivation technology, the INTERCEPT Blood System addresses broader safety risks and may also protect against as yet unknown, emerging pathogens which may threaten the blood supply in the future.

    About the INTERCEPT Blood System

    The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted diseases by inactivating certain pathogens that may be present in donated blood components, such as bacteria, HIV, and hepatitis B and C viruses. The INTERCEPT Blood System was the first pathogen inactivation system approved in Europe to treat platelets for transfusion. The INTERCEPT Blood System is also being developed for the treatment of plasma and red blood cells.

    About Baxter

    Baxter, through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

    About Cerus

    Cerus Corporation is developing novel products for cancer, infectious diseases, and blood safety based on multiple, innovative technology platforms. The company is building a pipeline of next generation cancer immunotherapies by combining its proprietary attenuated Listeria vector platform with promising disease antigens. These products are designed to stimulate innate and T-cell immune pathways in order to generate highly potent anti-tumor responses. Cerus is applying its Helinx technology to develop the INTERCEPT Blood System, which is designed to enhance the safety of blood components through pathogen inactivation. The company's strategy is to leverage the broad potential of its technologies and products through alliances. Cerus' partners to date include MedImmune and Johns Hopkins University for cancer immunotherapy, and Baxter International and BioOne for the INTERCEPT Blood System.

    Baxter, INTERCEPT Blood, and INTERCEPT AND PROTECT are trademarks of Baxter International Inc. Cerus and Helinx are U.S. registered trademarks of Cerus Corporation.

    About TÜV

    TÜV (Technischer Überwachungs-Verein) Product Services is one of the world leading organizations in the field of product testing, verification, consultancy and certification during the development and manufacture of products with regard to safety, electromagnetic compatibility, telecommunication competency, usability and quality. Around 1000 employees carry out certifications according to all current international standards. For manufacturers of medical devices, TÜV offers support with regard to certification and CE marking.

    Statements in this news release regarding potential efficacy and safety of products, potential regulatory approvals, product development and commercialization 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 risks and uncertainties related to the timing and results of clinical trials and other development activities, the acceptability of any data by regulatory authorities, actions by regulatory authorities and other government authorities, including the FDA and foreign counterparts, at any stage of the development or marketing process, technological advances in the medical field, additional financing activities, manufacturing, product demand and market acceptance and adoption of any products, competitive conditions, internal and external factors that could impact commercialization, and other factors discussed in each company's filings with the Securities and Exchange Commission. The companies do not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise; all forward-looking statements speak only as of the time when made. Actual results or experience could differ materially from the forward-looking statements.

    [1] te Boeckhorst PAW, Beckers EAM, Vos MC, Vermeij H, van Rhenen DJ: Clinical significance of bacteriologic screening in platelet concentrates. Transfusion 2005;45:514-519.

    Claeys H, Logghe F, Vandekerchove B, et al: Four-year experience with routine bacterial screening of platelet concentrates. Transfus Med 2003;1(Suppl 1):S326.

ots Originaltext: Baxter Healthcare SA
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