Aventis Behring Submits Application for FDA Approval of New Intravenous Alpha-1 Antitrypsin to Treat Hereditary Emphysema.

Business Editors

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Jan. 6, 2003

Aventis Behring L.L.C. announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of an intravenous form of Alpha1- Proteinase Inhibitor IV [Human] (A1-PI (H) IV), for use as chronic augmentation and maintenance therapy in individuals with Alpha1-Antitrypsin Deficiency (AAT Deficiency) or hereditary emphysema, a life-threatening genetic disorder.

The submission of the BLA for the treatment of AAT Deficiency is based on the outcome of clinical trials. The primary endpoints of the phase III 44-subject trial were successfully met and the study data suggest that the treatment is effective in maintaining serum levels of A1-PI above the threshold, over a 24-week period. These levels are considered by the Alpha-1 medical community to be protective against lung damage. In addition, the trial results indicate that A1-PI is delivered to the lower lung and is able to bind to neutrophil elastase, which is thought to cause the lung damage associated with AAT Deficiency. The trial also suggests that the product is comparable to existing marketed AAT replacement therapy.

This product previously received Fast Track designation from the FDA in December 2000. Under the FDA Modernization Act of 1997, the FDA facilitates and expedites the development and review of the application for the approval of a new drug if it is intended for the treatment of a serious or life-threatening condition and has the potential to address an unmet medical need.

"We are pleased with the submission of our BLA and are excited to be one step closer to regulatory approval of our intravenous Alpha1-Antitrypsin therapy. The Alpha-1 Community has been anxiously awaiting the entry of new products into this field, and we are gratified that we are in a position to try to help meet the demands of the community," said Dr. Ruedi Wager, Chief Executive Officer, Aventis Behring.

"A critical short supply of the therapy used to treat the lung disease associated with Alpha-1 has prevented many patients who are eligible from having access to care. We commend Aventis Behring for its efforts in developing a second product for this underserved population and we support their commitment to expedite this much needed product to ensure adequate supply for patients everywhere." said John W. Walsh, President & CEO, Alpha-1 Foundation.

About Alpha1-Antitrypsin Deficiency

AAT Deficiency affects approximately 100,000 Americans 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 AAT Deficiency is an inherited condition that may affect both the structure and the function of the lungs. Alpha-1 often leads to chronic emphysema and, in rare cases, may require liver transplantation. If left untreated, Alpha-1 can lead to premature death. Current treatment involves weekly intravenous infusions of the alpha1-antitrypsin protein that may take up to two hours. For more information, visit the web site of the Alpha-1 Foundation at www.alphaone.org.

About The Alpha-1 Foundation

The Alpha-1 Foundation is a not-for-profit organization dedicated to providing the leadership and resources to foster increased research, improved health, worldwide detection, and a cure for individuals afflicted with Alpha-1. The Foundation has funded more than $10.4 million in Alpha-1 research and programs including grants and awards to over 20 institutions in North America and Europe. An important activity of the Foundation is organizing and sponsoring scientific workshops and conferences that highlight the most critical areas of research related to this genetic condition. For more information call toll free, (877) 2-CURE-A1 (228-7321) or visit the Foundation web site, at www.alphaone.org.

About Aventis Behring

Aventis Behring, part of the Aventis family of companies, is a global leader in the plasma protein industry, providing a wide range of innovative and high-quality medicines to patients worldwide. Aventis Behring is dedicated to research and development in the area of human blood plasma as well as in emerging technologies. For more information about Aventis Behring, please visit our web site at www.AventisBehring.com.

Aventis (NYSE: AVE), a world leader in pharmaceuticals and agriculture, is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative prescription drugs for important therapeutic areas as well as human vaccines. In 2001, Aventis generated sales of (euro)17.7 billion, invested (euro)3 billion in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Statements in this news release other than historical information are forward-looking statement subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.