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Media Center Overview
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Gamunex® is Now Latex-Free
Product Enhancement for Preferred Liquid Intravenous Immune Globulin Exemplifies Talecris’ Commitment to Patient Safety
RESEARCH TRIANGLE PARK, N.C. (August 14, 2007) – Talecris Biotherapeutics, Inc. (www.talecris.com) announced today that all new releases of Gamunex® (Immune Globulin Intravenous [Human], 10%, Caprylate/Chromatography Purified) in the United States are latex-free. With the elimination of latex from the rubber stoppers used in the product packaging, physicians can confidently use Gamunex in their patients with latex allergy. Furthermore, the product enhancement for Gamunex demonstrates the Talecris effort to recognize and respond to the growing healthcare trend to establish entire medical environments as “latex-free.”
This move represents the Talecris commitment to continuous enhancement of the safety profile of its life-saving and life-enhancing products. “Patient safety has been and will continue to be a top priority for Talecris,” said Steve Petteway, Ph.D., Senior Vice President, Research & Development, Talecris Biotherapeutics. “Making Gamunex latex-free is an excellent example of our ongoing efforts to integrate technological improvements that allow us to provide the safest possible products for patients.”
Gamunex is the preferred liquid immune globulin intravenous (IGIV) among allergists / immunologists surveyed, according to Harris Interactive1. The new latex-free vials are currently being shipped and are becoming available to U.S. healthcare practitioners and patients.
1. Preference results for Gamunex based on blinded national survey of 358 allergists/immunologists from AMA Physician Master List choosing from a list of leading liquid and non-liquid IGIV brands. Survey was conducted by Harris Interactive from Dec. 2006 to Jan. 2007, and the results are statistically significant at p= 0.05.
Contact:
Lacy McMahon, Talecris Biotherapeutics
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, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis 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 about Gamunex, please see www.gamunex.com for Full Prescribing Information.
Survey Methodology
Results demonstrating preference for Gamunex among liquid IGIV brands included within an overall list of leading liquid and non-liquid IGIV brands are statistically significant with a 95% confidence interval (indicating that there is no more than a five in 100 chance that the observed differences could have been obtained by chance) and are based on a blinded, national survey of 358 allergists/immunologists from the AMA Physician Master List. The survey was conducted by Harris Interactive® on behalf of Talecris Biotherapeutics from December 17, 2006 to January 9, 2007. In order to qualify to complete the survey, the allergists/immunologists must have been in practice for at least one year, be active prescribers of IGIV, and be aware of at least two brands of IGIV. Respondents were asked to assume no difference in terms of availability, cost, and reimbursement when indicating their most preferred IGIV brand. The survey was conducted and the results were validated by a reputable, independent, third-party, Harris Interactive®, a worldwide market research and consulting firm best known for the Harris Poll®.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,000 talented people worldwide.
To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
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