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Study Demonstrates Aerosolized Prolastin® Using Unique Nebulizer Results in High Levels of Drug Deposited in Peripheral Regions of LungsEncouraging Results Bolster Talecris’ Ongoing Alpha1-Antitrypsin Aerosol Delivery Development Program RESEARCH TRIANGLE PARK, N.C. (September 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 APIXNEB® system (Activaero Technologies) to inhale Prolastin® (Alpha1–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 alpha1-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 alpha1-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. Contact: About Prolastin® Important Safety Information About Alpha1-Antitrypsin Deficiency About Talecris Biotherapeutics: Inspiration. Dedication. Innovation. 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. | ![]() |
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