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Research Triangle Park, NC - Talecris Biotherapeutics announced recently that Gamunex(R) can now be stored at room temperature (up to 25 degrees C, or 77 degrees F) for up to six months anytime during its 36 month shelf life. This new labeling will increase convenience and simplify storage options for healthcare professionals and patients. Further, it represents Talecris' continuing commitment to product innovation and ongoing development of its leading product, Gamunex(R), while reinforcing its pledge to the immune disorders community.

"The new room temperature storage guidelines for Gamunex(R) provide additional convenience for all healthcare providers by eliminating confusing storage calculations and reducing the need for refrigerated storage space," said Dr. Erwin Gelfand, Chairman, Department of Pediatrics, National Jewish Medical and Research Center.

Bruce Bunyan, Vice President, Global Strategic Marketing, Immunology, Talecris, commented on the organization's devotion to meeting customer needs. "This new simplified storage labeling represents an important convenience factor for our customers. We will continue to build on our nearly 25 years of leadership with liquid IGIV products by providing additional advances to improve customer convenience."

The new, simplified storage labeling follows Talecris' recent announcement of packaging improvements for Gamunex(R), further demonstrating the company's ongoing commitment to prevent product tampering and counterfeiting. The newly branded vial package includes the Talecris logo on a shrink-band of clear plastic wrap covering the neck and lid of the bottle, with a pull-tab for easy removal. If tampering has occurred, the shrink-band will be broken or loosened, and the disruption will be obvious to the naked eye. Each vial of Gamunex(R) is also equipped with a bar code that can be used to link the product to the patient's chart, to help ensure that each patient receives the proper medication and to minimize potential error by the healthcare provider.

In addition to the new simplified storage labeling, Gamunex(R) offers many convenience features for healthcare providers and patients. It is a 10% liquid product, and unlike a lyophilized product, does not have to be reconstituted. It comes in five individualized vial sizes ranging from 10 mL to 200 mL, and allows an infusion rate of up to 4.8 mL/kg/hour for the treatment of primary humoral immunodeficiency (PI) and idiopathic thrombocytopenic purpura (ITP). Gamunex(R) vials also contain an integrated IV sling for easy loading on the IV stand, increasing convenience and efficiency in the infusion suite.

Talecris also recently announced Food and Drug Administration (FDA) approval to provide data in the product labeling for Gamunex(R) demonstrating the capacity of several unique steps in the manufacturing process remove pathogenic prions, such as those associated with the development of variant Creutzfeldt-Jakob Disease (vCJD). Creating additional confidence for patients and treaters, the new labeling provides quantitative information demonstrating a high margin of safety for Gamunex(R) against emerging pathogens, such as the abnormal pathogenic prion proteins associated with "Mad Cow" disease and vCJD in humans. This is the first such approval from the FDA for a liquid IGIV product and demonstrates Talecris' continuing leadership in the area of pathogen safety.

"All these recent advances, including the inclusion of TSE clearance information, the tamper-evident packaging, and now the simplified room temperature storage, demonstrate an ongoing commitment by Talecris to support the needs of treaters and patients who rely on Gamunex(R)," said Dr. Gelfand.

SOURCE: Talecris Biotherapeutics