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Media Center Overview
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Landmark Alpha-1 Historical Medical Literature Available from Talecris Biotherapeutics
Compendium of classic papers compiled in honor of 20-year history of Prolastin®
RESEARCH TRIANGLE PARK, N.C. (May 22, 2006) – Talecris Biotherapeutics, a leading global biological products and biotech company, is making available a compendium of classic papers in the area of alpha-1 antitrypsin (AAT) deficiency in honor of the 20th anniversary of the filing of the Biologic License Application (BLA) for Prolastin® (Alpha1-Proteinase Inhibitor [Human]). The compendium, entitled "Alpha-1 Antitrypsin Deficiency: A History Through the Medical Literature," brings together key publications from the last 40 years that have increased understanding the pathogenesis, prevalence, and effective treatment of the disease.
Robert A. Sandhaus, M.D. Ph.D., Professor of Medicine and Director of the Alpha-1 Program at National Jewish Medical and Research Center, Denver, Colo., and Clinical Director of the Alpha-1 Foundation, Miami, Fla. is the guest editor for the compendium. "This collection brings together landmark publications that have been instrumental in shaping our knowledge of AAT deficiency over the past 40 years. Given the pivotal role that Prolastin® has played in key clinical studies, it is especially fitting that Talecris would make this historically important compendium available in honor of the 20-year anniversary of the filing of the BLA."
PR08-0506 As the first and only alpha1-proteinase inhibitor available for clinical use for 15 years, Prolastin® was utilized in most therapeutic intervention studies in the 1990s and early 2000s. Several of the key Prolastin® treatment trials are included in the compendium. Data from these studies provided information on expected results from AAT augmentation therapy, and set standards against which newer therapies were compared. "Most of what we know and continue to learn about treating Alpha-1 is the result of having Prolastin® available these last 20 years," said Dr. Sandhaus.
"This compendium is an elegant and meaningful way to compile past learnings and create an important historical reference," said Alberto Martinez, M.D., President and CEO of Talecris Biotherapeutics. "But our unprecedented two-decade legacy of commitment to the Alpha-1 community must consistently be reinvigorated. To that end, we are moving forward with significant investments in advanced manufacturing processes that will further enhance supply. Moreover, we are seriously exploring the potential for development of an aerosol formulation, representing the future of AAT delivery."
Initial copies of this important historical reference, published by Cambridge Medical Publications, United Kingdom, are being made available through the Talecris medical exhibition booth at the annual international conference of the American Thoracic Society being held in San Diego, Calif., May 19-24, 2006.
Contact:
Lacy McMahon
Tel.: 919.316.6316, Fax: 919.316.6673
E-mail: lacy.mcmahon@talecris.com
About Prolastin®
Prolastin® is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI with clinically demonstrable panacinar emphysema. Individuals with selective IgA deficiencies who have known antibody against IgA should not receive Prolastin®, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
PR08-0506 Important Safety Information In clinical studies with Prolastin®, reactions (none severe) were observed in 1.16% of infusions, the most common events being fever, lightheadedness and dizziness. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For additional information on Prolastin®, please see full prescribing information at www.prolastin.com.
About Alpha-1
Alpha-1 Antitrypsin Deficiency, also known as AAT Deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein AAT. It is most common in the Caucasian population of northern Europe and North America. AAT Deficiency is also the most common cause of genetic liver disease in children, and genetic emphysema (shortness of breath) in adults. Individuals suffering from AAT Deficiency often develop severe obstructive pulmonary diseases (COPD) causing disability and premature death. AAT Deficiency affects some 150,000 people in North America and Europe.
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 of approximately $1 billion in 2005, is headquartered in biotech hub Research Triangle Park, N.C. and employs more than 1,800 talented people. 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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