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Media Center Overview
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Talecris Celebrates the Second Anniversary of Gamunex®
Celebration marks another milestone in Talecris' history of "firsts" in liquid immunoglobulin intravenous (IGIV) therapy
RESEARCH TRIANGLE PARK, N.C., (Oct. 13, 2005) – Talecris Biotherapeutics is celebrating the second anniversary of the launch of Gamunex® – introduced in the fall of 2003 as the first completely new IGIV therapy in more than a decade. Gamunex® is used as antibody replacement therapy for Primary Immune Deficiency diseases (PI), and as an immune modulator for those who suffer from idiopathic thrombocytopenic purpura (ITP).
"The launch of Gamunex® offered the PI community an innovative choice for their treatment," said Marcia Boyle, president and chairman of the Immune Deficiency Foundation. "Talecris truly cares about the patient community – they are constantly improving and updating formulations of their IGIV products. We congratulate them on this important milestone."
Gamunex® is yet another example of how Talecris Biotherapeutics has paved the way in liquid IGIV production for nearly 25 years. In this time, Talecris has supplied more than 100 million grams of liquid IGIV to patient communities, without a single documented case of viral transmission.
A Legacy of "Firsts"
In 1981, Talecris (then Bayer Biological Products) was the first to introduce a liquid, ready-to-use IGIV product in North America, Gamimune® 5% (Immune Globulin Intravenous [Human], 5%). In subsequent years additional processing advancements occurred. Five years after the initial introduction of liquid IGIV, Gamimune® N, 5% (Immune Globulin Intravenous [Human], 5%), the earliest "native" preparation was introduced. It was formulated at a low pH for optimal stabilization.
Today, liquid 10% IGIV is an established product as a result of advances made by Talecris more than a decade ago. In 1992, Talecris introduced Gamimune® N, 10% (Immune Globulin Intravenous [Human], 10%), the world's first high concentration liquid ready-to-use preparation. Encouraged by positive responses from patients to Gamimune® N, 10% and based on a continuing commitment to further advance the state of care, Talecris invested in a completely new IGIV, taking a "clean slate" approach to the new product's creation. The result was Gamunex®, the first IGIV production process to use Caprylate/Chromatography to 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.
As a result of its innovative production process, Gamunex® has an excellent safety and tolerability profile. To support the regulatory approvals of Gamunex® in the United States, Canada, and Germany, the company conducted the largest and most rigorous licensure-relevant clinical trials in IGIV history, demonstrating excellent efficacy, safety, and tolerability compared to Gamimune® N, 10% in patients with PI and ITP. These groundbreaking clinical trials successfully demonstrated – for the first time in IGIV history – clinical evidence for excellent efficacy and tolerability for an IGIV product.
"Talecris is pleased to see our investment in rigorous clinical trials result in an improved treatment choice for patients," said Stephen R. Petteway, Jr., Ph.D., Senior Vice President, Research and Development, Talecris Biotherapeutics. "Our commitment to fully-developed clinical programs helps us provide therapies that advance care for our patients and help us accomplish our primary vision to be the recognized leader in developing and delivering premium protein therapies."
The Talecris Commitment to Innovation and Reliable Supply
More than $250 million has been invested in a new state-of-the-art production facility designed and built around the new manufacturing process for Gamunex®. 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, in response to market demand, Talecris has significantly increased the amount of its IGIV product sold to the U.S. market. In response to tightness in IGIV supply in the U.S. market in 2005, Talecris has taken action to further increase production of Gamunex®.
Since the launch in 2003, Talecris has continued to improve Gamunex® with multiple product safety and convenience enhancements. For example, Gamunex® now can be stored at room temperature (up to 25o C or 77o F) for up to six months anytime during its 36-month shelf-life.
As an example of the Talecris leadership in advancing pathogen safety, Gamunex® product labeling now contains data demonstrating the capacity of several individual steps in the manufacturing process to remove pathogenic prions. This is the first such approval from the U.S. Food and Drug Administration (FDA) for a liquid IGIV product.
Product safety innovations also extend beyond Talecris' manufacturing facility. Talecris Biotherapeutics has implemented a number of updates in the areas of packaging safety that provide additional security features through tamper-evident packaging initiatives. The new Talecris brand logo appears on the Gamunex® vial label, carton, package insert, and clear plastic shrink-banding covering the neck and lid of the bottle. Each vial of Gamunex® is equipped with a bar code that can be used to link the product to the patient's chart, helping ensure each patient receives the proper medication and minimizing potential error by the healthcare provider.
Additionally, Talecris maintains a close partnership and detailed contracts with its distributors, further enhancing the company's efforts to ensure that its products are distributed only through approved channels. In addition to maintaining their ability to inspect distributor facilities and audit records, Talecris requires distributors to provide more detailed reporting on product disposition, along with monthly inventory reconciliation.
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 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 has 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 e-mail updates when new information is added to the Talecris Web site, please register at www.talecris.com/media_contact.cfm.
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