Study Demonstrates Aerosolized Prolastin Using Unique Nebulizer Results in High Levels of Drug Deposited in Peripheral Regions of LungsRESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sep 18, 2007 - Talecris Biotherapeutics, Inc. (http://www.talecris.com) presented new data today at the 2007 Annual Congress of the European Respiratory Society (ERS) demonstrating that using the AKITA2(R) APIXNEB(R) system (Activaero Technologies) to inhale Prolastin(R) (Alpha-1 Proteinase Inhibitor (Human)) results in very high levels of drug deposited in the central and peripheral regions of the lungs. The clinical study data demonstrated that distribution in patients with alpha-1 antitrypsin (AAT) deficiency and cystic fibrosis who had moderate to severe lung function impairment was similar to levels achieved in healthy subjects.
The study utilized the AKITA2 APIXNEB inhalation system to aerosolize Prolastin for inhalation. This system utilized controlled breathing patterns to optimize drug deposition. After inhalation of a single dose, patterns of Prolastin deposition were measured in the lungs. The amount of Prolastin that deposited in central and peripheral lung regions following a single dose inhalation was determined and compared among six healthy volunteers, seven patients with AAT deficiency, and seven patients with cystic fibrosis. Results demonstrated that over 70% of the dose that was placed in the nebulizer was deposited in the lungs with a lower proportion either deposited in the oropharynx or exhaled. Between 41 and 43 percent of the Prolastin was distributed in peripheral areas of the lungs, and no differences existed among the groups. Most importantly, the inhalation procedure was well tolerated even by patients with poor lung function and gave similar deposition results compared to normal volunteers.
"The aim of aerosolized alpha-1 proteinase inhibitor is to achieve homogeneous drug deposition within the periphery of the lungs," said Steve Petteway, Ph.D., Senior Vice President, Research and Development, Talecris Biotherapeutics. "These results are very encouraging and suggest that, by using the AKITA2 APIXNEB inhalation system, significant amounts of Prolastin can be delivered to the area of the lungs where the greatest therapeutic benefit is anticipated. We will build on these results as we continue our active AAT aerosol development program, a program that has the potential to significantly improve patient convenience for administering AAT."
Talecris has entered into an exclusive partnership with Activaero for use of the AKITA2 APIXNEB inhalation system in the development of aerosolized AAT therapy.
Prolastin(R) is indicated for chronic augmentation 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 Antitrypsin Deficiency
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: Inspiration. Dedication. Innovation.
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 $1.1 billion in 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 3,000 talented people worldwide.
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.
Lacy McMahon, 919-316-6316
Posted: September 2007