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FDA Approves Ketek (Telithromycin) Tablets First-in-class antibiotic to treat mild to moderate community-acquired respiratory tract infections BRIDGEWATER, NJ -- April 8, 2004 -- Aventis (NYSE:AVE) announced that the U.S. Food and Drug Administration (FDA) has approved Ketek™ (telithromycin) tablets to treat acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and mild to moderate community-acquired pneumonia, including those infections caused by multi-drug resistant Streptococcus pneumoniae, in patients age 18 and older. Ketek, the first in a new class of antibiotics known as the ketolides, was specifically designed to treat community-acquired respiratory tract infections (RTIs). "Physicians, now more than ever, need a new therapeutic option to treat their patients suffering from mild to moderate RTIs, especially since approximately one-third of Streptococcus pneumoniae (the most common pathogen causing RTIs) are resistant to commonly used first line antibiotics," said Frank Douglas, MD, PhD, Executive Vice President and Chief Scientific Officer at Aventis. "Ketek's innovative mechanism of action selectively targets common respiratory pathogens, including resistant strains, without significant effects on bacteria not normally involved in RTIs. This may be an important factor in minimizing the development of antibiotic resistance, a critical public health concern and one that I've seen in my clinical practice," added Paul Iannini, MD, Chairman, Department of Medicine, Danbury Hospital and Clinical Professor of Medicine, Yale University. More than seven million patients have used Ketek since it was first introduced in major European, Latin American, and Asian markets. Ketek has been very well accepted by healthcare professionals and patients in Japan and France, the second and third largest antibiotic markets worldwide. The global market potential for Ketek is expected to exceed € 1.5 billion. In clinical trials, the most commonly reported side effects were nausea, headache, dizziness, vomiting, and diarrhea. To receive a copy of this release or any recent release, visit the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com. SOURCE: Aventis E-mail this page to a friend or colleague! To print, use this version