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Extensive Post-License Data Reaffirm Clinical Safety Profile of Prolastin(R)

Posted on: Tuesday, 5 September 2006, 09:00 CDT

The largest safety data set among alpha-1 antitrypsin augmentation (AAT) therapies compiled over the longest period of time reaffirms the clinical safety and tolerability of Prolastin(R) (Alpha1-Proteinase Inhibitor (Human)) in treating patients with AAT deficiency. Presented today at the 2006 Annual Congress of the European Respiratory Society, safety data collected since the original approval of Prolastin(R) in 1987 now represent more than 18 years of clinical experience and 40,826 patient-years of exposure. Results demonstrate that Prolastin(R) continues to be well tolerated with respect to drug interactions, overdose, and abuse potential.

Thomas Bernhardt, M.D., Ph.D., at Bayer HealthCare, and lead author on the study commented on the significance of the safety information. "These data represent an unprecedented, comprehensive collection of adverse events from clinical trials, post-marketing surveillance, spontaneous safety reports, and information obtained from regulatory authorities and the published literature. Based on the extensive clinical experience and the data from this analysis, we know that Prolastin(R) is a safe biological product for patients with AAT deficiency."

The pattern of the adverse event reports in the presented safety data set is consistent with the known safety profile of Prolastin(R). Reported serious and previously unlisted events coincided with alternative explanations either due to the symptoms of the underlying disease or relevant medical history. Likewise, the most frequently reported non-serious and unlisted events represented a more specific description of clinical symptoms consistent with labeling (e.g., allergy-like or flu-like reaction). For the majority of the events, the frequency of reports was very small (three cases or fewer), reflecting the idiosyncratic nature and random occurrence of these events. Overall, these reports do not alter the benefit-risk ratio or suggest any new risks for Prolastin(R).

Prolastin(R) was available as the only alpha-1 proteinase inhibitor for more than 15 years, and allowed significant advances in the understanding and treatment of AAT deficiency. "Although Prolastin(R) is a well-characterized product with the longest and most extensive clinical experience among AAT augmentation therapies, it is nevertheless reassuring to review such a comprehensive data set that reaffirms its safety and tolerability," said Alberto Martinez, M.D., President and CEO of Talecris Biotherapeutics. "Our commitment at Talecris is to continue building knowledge and advancing care for the global Alpha-1 community through new research and product development innovations."

About Prolastin(R)

Prolastin(R) 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(R), since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.

Important Safety Information

In clinical studies with Prolastin(R), 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(R), 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.

Source: Business Wire

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