Inhale receives Orphan Designation for inhaleable hereditary emphysema therapy.

Aventis Behring LLC (King of Prussia, PA; 610-878-4822), a global leader in the plasma protein industry, and Inhale Therapeutic Systems, Inc. (San Carlos, CA; 650-631-3138), a pioneer in drug delivery technology solutions, announced 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 United States Food and Drug Administration (FDA) granted orphan drug designation to this inhaleable dry powder formulation of Alpha1-Antitrypsin (Human). Orphan drug designation could provide United States 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 LLC. "Receiving Orphan Medicinal Product Designation for the inhaleable form of Alpha1-Antitrypsin moves us closer toward our goal of providing the Alpha-1 Community worldwide with a novel treatment option for this under-recognized disease."

"We believe that a dry powder inhaleable Alpha1-Antitrypsin could decrease the amount of drug used compared to intravenous infusion. Further, it may provide patients with more time to enjoy life through shortening dosing time and providing a more patient-friendly delivery mode," said Robert Chess, Chairman, Inhale Therapeutic Systems, Inc.

"We are pleased that regulatory authorities in Europe and the United States are recognizing the unique needs of the Alpha-1 Community," said John W. Walsh, President and CEO of the Alpha-1 Foundation. "As there is currently no cure for this hereditary disorder, Alpha-1 patients worldwide salute companies such as Aventis Behring and Inhale for their dedication to developing novel treatment formulations of Alpha1-Antitrypsin."

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 United States, 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-Anti-trypsin 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 intra-venous infusions that may take up to two hours.

Under the collaboration between the two companies, Aventis Behring manufactures the active substance for treatment of Alpha1-Antitrypsin Deficiency. Inhale Therapeutic Systems produces the dry powder formulation for use with its proprietary inhalation system and processes and packages the powder for usage. Aventis Behring oversees the clinical pro-gram and will be responsible for the worldwide commercialization of any approved products result-ing from the collaboration.

Aventis Behring is a global leader in the plasma protein industry, providing a wide range of innovative, high quality therapies and unique support services to patients worldwide. Aventis Behring is dedicated to the research and development of proteins from human blood plasma and emerging technologies.

Aventis, a world leader in pharmaceuticals and agri-culture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales of 22.3 billion Euros and employed around 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhone-Poulenc SA of France. Corporate headquarters are in Strasbourg, France.

Inhale Therapeutic develops advanced drug delivery solutions for the biopharmaceutical industry. Inhale is focused on two main opportunities: improved delivery of macromolecules, including peptides and proteins, and improved performance of drug powders. Inhale is pioneering inhaleable delivery of macromolecules, supercritical fluids processing for powder particle production and advanced PEGylation. Inhale is collaborating with major pharmaceutical and biotech-nology companies, including Amgen, AstraZeneca, Aventis Behring, Biogen, Bristol-Myers Squibb, Glaxo-SmithKline, Lilly, Pfizer, Pharmacia, and Roche.