| Aventis Behring Receives FDA Approval
for Zemaira for Alpha1-Proteinase Inhibitor Deficiency and Emphysema
ZemairaTM Is a New, Safe, And Effective Chronic Augmentation and Maintenance Therapy that Can Offer Benefits to Patients KING OF PRUSSIA, Pa (BUSINESS WIRE) July 10, 2003 Aventis Behring L.L.C. announced today that Zemaira(TM) (alpha(1)-proteinase inhibitor (human)) (A(1)-PI) has received approval from the U.S. Food and Drug Administration for use as chronic augmentation and maintenance therapy in individuals with alpha(1)-proteinase inhibitor deficiency (Alpha-1), a life-threatening genetic disorder in some individuals, who demonstrate clinical evidence of emphysema. Left untreated, this form of emphysema can be fatal. "Zemaira(TM) establishes a new standard for intravenous therapy for Alpha-1 patients. Zemaira(TM) was purposely developed to be a high purity product that requires half the infusion volume and approximately half the infusion time of other currently available therapies. In clinical trials, Zemaira(TM) maintained alpha(1)-proteinase inhibitor levels above the historical target threshold," said Dr. Ruedi Wager, chief executive officer, Aventis Behring. "Additionally, Zemaira(TM) can also be stored and transported at room temperature, allowing people with A(1)-PI flexibility in their lifestyle." "Aventis Behring has invested approximately $170 million and many years in the development of therapies for the Alpha-1 Community. We are pleased that Zemaira(TM) will provide a new choice for those people who need it," continued Dr. Wager. "The Alpha-1 Foundation is pleased that Zemaira(TM) will soon be available to the Alpha-1 Community. Historically, people with Alpha-1 have been concerned with the critical short supply of the therapy," said John W. Walsh, president & chief executive officer, Alpha-1 Foundation. "Zemaira(TM) underlines Aventis Behring's commitment to the underserved Alpha-1 Community. By developing a high quality product using new state-of-the-art purification technology, Aventis Behring will provide desperately needed product so people with Alpha-1 can focus more on their lives and less on when their therapy will be available." "With the protein content of each dose being at least 90% A(1)-PI protein, we believe that Zemaira(TM) establishes a new standard in purity that results in less non-therapeutic proteins being introduced to people with Alpha-1," said Dr. Robert Sandhaus, clinical director and executive vice president, Alpha-1 Foundation. "Additionally, the Alpha-1 Community is grateful that more treatment is becoming available for this often unrecognized or misdiagnosed disease." Because Alpha-1 is a serious or life-threatening condition, Zemaira(TM) received Fast Track designation from the FDA in November 2000. The license application, submitted in January 2003, received a priority review by the FDA. 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. Aventis Behring has also developed a new program for those who will be treated with Zemaira(TM). The Zemaira(TM) Assurance Program is designed to ensure that qualified people who rely on this product can continue to receive Zemaira(TM) even if they experience a lapse in third-party, private health insurance. Patients and healthcare professionals should visit http://www.Zemaira.com or call 1-866-Zemaira (1-866-936-2472) for more information about Zemaira(TM) and Aventis Behring's unique programs. About Alpha(1)-Proteinase Inhibitor Deficiency Alpha-1 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, chronic emphysema caused by Alpha-1 is an inherited condition that may affect both the structure and the function of the lungs and may affect individuals as young as thirty years of age. If left untreated, Alpha-1 can lead to premature death. The Alpha-1 Foundation is a not-for-profit foundation dedicated to providing the leadership and resources that will result in increased research, improved health, worldwide detection, and a cure for Alpha-1. The majority of the Board of Directors is either diagnosed with Alpha-1 or is a family member of an individual diagnosed with Alpha-1. For more information, please contact the Alpha-1 Foundation at 1-888-825-7421 or via their website, http://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: http://www.AventisBehring.com. Aventis ( NYSE:AVE) is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of EUR17.6 billion, invested EUR3.1 billion in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: http://www.aventis.com. Statements in this news release other than historical information are forward-looking statements 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. NOTE TO EDITORS: In the medical name alpha(1) noted in this news release, the parentheses indicate that the '1' is a subscript. This symbol may not appear properly in some systems. Contact: Aventis Behring
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