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Media Center Overview
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Talecris Announces Extended Room Temperature Storage for Gamunex®
New simplified storage labeling provides greater convenience for patients, healthcare professionals
RESEARCH TRIANGLE PARK, N.C. (August 18, 2005) – Talecris Biotherapeutics announced today that Gamunex® can now be stored at room temperature (up to 25o C, or 77o 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®, while reinforcing its pledge to the immune disorders community.
"The new room temperature storage guidelines for Gamunex® 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®, 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® 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® 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® 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® 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® 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®," said Dr. Gelfand.
The Talecris Commitment to Innovation and Reliable Supply
Because the production method determines the efficacy, tolerability, and safety of an IGIV product, Gamunex® was developed using a "clean sheet" approach to create a completely new and optimal production process for the IGIV therapy. This innovative process includes breakthrough purification steps using Caprylate/Chromatography that improve product purity and also help preserve the biological activity of the product by replacing the solvent-detergent method used in previous generations of IGIV products. To support the regulatory approvals of Gamunex® in the United States, Canada, and Germany, the largest and most rigorous clinical trials program in IGIV history were conducted, demonstrating excellent efficacy, safety, and tolerability of Gamunex® in patients with ITP and PIDD.
More than $250 million has been invested in a new state-of-the-art production facility designed and built around the new Gamunex® manufacturing process. The facility is the first of its kind dedicated solely to the production of IGIV, allowing Talecris Biotherapeutics to produce a safe and reliable supply of Gamunex®. Since 2001, IGIV releases to the United States have increased by 46%, and to continue meeting increasing demand for product, Talecris increased supply to the U.S. market by 14% from 2003 to 2004. In 2005, we have taken action to further increase production of Gamunex® including processing additional liters of plasma.
Contact: Lacy McMahon
Tel.: 919.316.6316, Fax: 919.316.6673
E-mail: lacy.mcmahon@talecris.com
About Gamunex®
Gamunex® is a lifesaving IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people and is used to treat a variety of health problems, both as a means of immune replacement and for modulating the immune system. Gamunex® is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP).
Important Safety Information
Gamunex® is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex® does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
For additional information on Gamunex®, please see Full Prescribing Information at www.gamunex.com.
About Talecris Biotherapeutics
Talecris is a newly formed company with the assets and history of Bayer HealthCare Biological Products Division's plasma business. With global headquarters in Research Triangle Park, N.C., primary manufacturing facilities for Talecris products in Clayton, N.C., and additional fractionation and manufacturing facilities of Precision Pharma Services in Melville, N.Y, Talecris employs nearly 1700 people.
Inheriting a legacy of more than 60 years of providing lifesaving and life-enhancing plasma-derived therapeutic proteins, Talecris is well positioned to become recognized as the global leader in developing and delivering premium protein products. Through its people, technology, and state-ofthe- art facilities, Talecris will build on this long history of innovation through a focused, entrepreneurial approach to new product development, application of cutting-edge manufacturing technologies, and marketing and customer service.
Talecris is talented industry professionals providing critical care treatments and services for patients, while maintaining a vision for the future of care.
Information about Talecris can be found at www.talecris.com. To receive email updates when new information is added to the Talecris Web site, please register at www.talecris.com/media_contact.cfm.
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