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Europe Grants Orphan Drug Status to Alpha1-Antitrypsin for Hereditary Emphysema SAN CARLOS, CA -- July 26, 2001 -- Aventis Behring L.L.C. and Inhale Therapeutic Systems, Inc. announced today that Aventis has received Orphan Medicinal Product Designation from the European Commission for the inhaleable form of Alpha1-Antitrypsin (Human), currently in clinical trials for the treatment of hereditary emphysema. The Orphan Medicinal Product Designation from the European Commission has the potential to provide for up to ten years of market exclusivity in the European Union. Additionally, in January 2000, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to this inhaleable dry powder formulation of Alpha1-Antitrypsin (Human). Orphan drug designation could provide U.S. marketing exclusivity for seven years upon approval by the FDA. "While this disease is rare, patients suffering from this inherited disorder experience reduced breathing function that drastically undermines their lifestyle and ability to function in society. Aventis Behring is pleased to be working with Inhale to develop this revolutionary, inhaleable formulation which we believe may help many patients resume a more normal life," said Gail Schulze, Chief Operating Officer of Aventis Behring L.L.C. The inhaleable form of Alpha1-Antitrypsin was recently evaluated in a Phase I clinical trial in the United States. The primary objective of this study was to examine the safety and tolerance of escalating doses of inhaleable Alpha1-Antitrypsin. All doses were well tolerated and a dose response was achieved. Alpha1-Antitrypsin Deficiency affects approximately 100,000 Europeans and a similar number in the US, according to the Alpha-1 Foundation, a not-for-profit organization dedicated to increasing the awareness and early diagnosis of this life-threatening genetic disorder. Unlike emphysema that develops as a result of smoke inhalation, emphysema caused by Alpha1-Antitrypsin Deficiency is an inherited condition that may affect both the structure and the function of the lungs and can lead to chronic emphysema and premature death if left untreated. Current treatment involves weekly intravenous infusions that may take up to two hours. SOURCE Aventis Behring L.L.C. E-mail this page to a friend or colleague! To print, use this version