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Talecris Biotherapeutics Celebrates 25 Years of Life-Saving Treatment for People with Primary Immune Deficiency
25-year anniversary of developing first liquid IVIG therapy commemorated through sponsorship of "Enhancing the Recognition and Treatment of PID" symposium at European Society of Immunodeficiencies
BUDAPEST, HUNGARY (Oct. 5, 2006) – Twenty-five years after the introduction of the first ready-to-use liquid intravenous immunoglobulin (IVIG) for treating patients with primary immunodeficiencies (PID), the most critical components in achieving optimal care for PID patients remain exactly the same: accurate, early diagnosis, and appropriate treatment. In honor of the 25th anniversary of developing and launching the first liquid IVIG, Talecris Biotherapeutics sponsored a symposium at the XIIth meeting of the European Society for Immunodeficiencies (ESID) in Budapest. In this symposium, clinical experts reviewed new diagnostic approaches, treatments, and prophylaxis designed to produce the best clinical outcomes and minimize risks for adverse events for patients with recurrent infections.
Chaired by Dr. Volker Wahn of the Immunodeficiency Center of the Charité (IDCC), Berlin, the 25th anniversary symposium explored diagnostic approaches based on patients' clinical symptoms, and presented optimal treatment approaches based on major clinical advances offered by IVIG therapy over the last 25 years. Joining Dr. Wahn was the following renowned international faculty:
• Uve Wintergerst, M.D., Department of Immunology, University Children's Hospital in Munich, discussed the difference between physiologic and pathologic susceptibility to infection, and shared indicators, signs, and symptoms that may identify PID, a pathophysiologic susceptibility, as early as possible.
• Rheinhold E. Schmidt, M.D., Department of Clinical Immunology, Medical University of Hannover, presented research on the role of IVIG in infection prophylaxis demonstrating that early IVIG replacement reduces the incidence of severe acute bacterial infections and prevents life-threatening complications, limits organ damage, and improves quality of life.
• Erwin W. Gelfand, M.D., Division of Cell Biology, Department of Pediatrics, National Jewish Medical and Research Center in Denver, presented data on characteristics of IVIG treatments that impact their safety, tolerability, and convenience.
In his lively discussion, Dr. Gelfand reiterated that patients with PID rely on IVIG to remain healthy; however, not all IVIG preparations are created equal. Specifically, data show that differences in the osmolality of various IVIG preparations can determine the speed with which they can be administered and the occurrence of serious side effects. Lyophilized IVIG formulations (requiring reconstitution of a powder preparation) and those with higher salt or sugar concentrations may be associated with certain serious adverse reactions such as myocardial infarction, stroke, abnormal blood clotting, or kidney dysfunction. Furthermore, individual patient risk factors can affect adverse reactions, and should be carefully considered when selecting an IVIG preparation. Since many serious events can occur upon the initial infusion of an IVIG product, special care should be taken in the initial choice of IVIG.
In addition to information on liquid immunoglobulin preparations, there was also discussion regarding newer subcutaneous preparations, and when it might be appropriate to consider this option with a focus on individualized care meeting patients' needs, and continued regular interaction between patients and their physicians. According to Dr. Wahn, "It is important for physicians, nurses, and patients to be broadly aware of immune globulin administration and preparation differences. However, individualized care and treatment based on each patient's needs continues to be vital for the PI community. There is no replacement for the regular interaction between patients and their physicians, which for the past 25 years has remained the cornerstone of optimal care."
2006 marks the 25-year anniversary of the first liquid IVIG, Gamimune®, developed and launched in 1981 by Cutter Laboratories. Talecris Biotherapeutics traces its roots back to Cutter through Bayer Biological Products and Miles Laboratories. In 2003 and 2004, Gamunex® was launched in the United States, Canada and Germany by Bayer, which became Talecris in 2005. As a result, Talecris has provided a legacy of historic firsts and innovations in liquid IVIG therapy over the last 25 years.
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, 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 on Gamunex®, please see Full Prescribing Information at www.gamunex.com.
About Talecris Biotherapeutics
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, which earned revenues exceeding $1 billion through the year ending June 30, 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 2,000 talented people worldwide. In November of 2006, Talecris will be opening its European headquarters in Frankfurt, Germany. 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.eu.
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