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Manufacturing process removes or inactivates known and emerging pathogens
MUNICH, GERMANY and RESEARCH TRIANGLE PARK, N.C. (Sept. 5, 2006) – Talecris Biotherapeutics presented data today reconfirming the excellent pathogen safety profile for Prolastin® (Alpha1-Proteinase Inhibitor [Human]) and further establishing its recognized industry-leading position in this area. Information shared at the 2006 Annual Congress of the European Respiratory Society (ERS) demonstrated that the manufacturing process for Prolastin® significantly removes or inactivates key viruses as well as pathogenic prions such as those associated with variant Creutzfeldt-Jakob Disease (vCJD, the human form of "Mad Cow"). Furthermore, the high margin of pathogen safety is affirmed by nearly two decades of clinical experience and more than 1.5 million infusions of Prolastin® for alpha-1 antitrypsin augmentation therapy without a documented report of a virus or other infectious agent being transmitted.
Dr. Dominique Pifat, Director, Virology/TSE at Talecris Biotherapeutics, and lead author of the poster presentation, commented on the importance of the data. "Our robust processes, which include four separate viral reduction steps, demonstrate that significant levels of pathogens can be removed or inactivated in the highly unlikely event that they are present in pools of plasma prior to manufacture. By confirming removal or inactivation of a variety of enveloped and non-enveloped viruses, as well as the pathogenic prions, we are able to provide assurance that Prolastin® can be safely infused without threat of contamination."
Data presented by Dr. Pifat demonstrated, depending on the specific virus, between 10 million and 10 quintillion (1 followed by 18 zeros) particles can be removed by the manufacturing process for Prolastin®. Furthermore, the process can remove more than 100 billion pathogenic prions. "The numbers provide a significant margin of safety," said Dr. Pifat. "Because Talecris utilizes the highest industry standards for donor screening and plasma testing, along with its proven removal and inactivation processes, the theoretical risk of viral or other pathogen transmission with Prolastin® is extremely remote."
Talecris is a recognized leader in plasma screening and testing, as well as in the integration of processes capable of removing or inactivating known and emerging pathogens including HIV, hepatitis, West Nile Virus, vaccinia, avian flu, and the pathogenic prions associated with vCJD. Representing a specific example of its pathogen safety leadership, Talecris is the first and only plasma fractionator conducting in-house testing on source plasma for human immunodeficiency virus (HIV), hepatitis C (HCV), and HBV using FDA-approved tests. This allows even greater control in confirming the safety of plasma pools above and beyond the strict standards and protocols already in place for the screening and donation process.
"Without question, our most important objective is to provide reliable supplies of the safest possible Prolastin® for the Alpha-1 community," said Alberto Martinez, M.D., President and CEO of Talecris Biotherapeutics. "Our pathogen safety expertise, combined with nearly two decades of clinical experience, provides patients with a strong sense of comfort and confidence that Prolastin® is a safe and reliable product. We are continuing our industry-leading R&D, including innovative applications of pathogen safety science, to benefit the patient communities we serve. "
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 proteinase inhibitor 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.
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 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. 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.
Important Safety Information
Prolastin®, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. Weekly Prolastin® therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin®, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Prolastin®, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here for Prolastin® full Prescribing Information.
Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor or healthcare provider if you have any questions about your health or any of your medications.
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