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ECCMID: Once Daily Ketek As Safe And Effective As Levofloxacin Three Times Daily In Treating Patients With Community Acquired Pneumonia (Cap) MILAN, ITALY -- April 29, 2002 -- KETEK® (telithromycin) 600 mg is an effective, well-tolerated empirical treatment for community acquired respiratory tract infections (RTIs), and is equivalent in efficacy to the quinolone levofloxacin - 100mg dosed three times daily - when dosed for seven days in the treatment of CAP, according to data from Japan presented at the 12th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). KETEK 600 mg once-daily for five days is also associated with excellent clinical and bacteriological outcomes in patients with a wide range of RTIs, including acute tonsillitis and acute bacterial exacerbation of chronic pulmonary disease. RTIs are the most common infections treated by healthcare practitioners and represent a significant societal burden, causing 50 million deaths globally each year. The study was conducted in Japan where dosing for KETEK is filed for 600 mg to account for a lower body mass index (BMI) and generally a lower body weight of Japanese patients. KETEK was effective in treating CAP caused by common and atypical/intracellular respiratory pathogens and strains of S. pneumoniae resistant to penicillin and the macrolide erythromycin. Overall clinical efficacy rates in the per-protocol population for KETEK, the first ketolide antibacterial approved for clinical use, and for levofloxacin were 93.6% and 87.8%, respectively, while overall clinical cure rates in the per-protocol population were 91.5% for KETEK and 81.4% for levofloxacin. Once Daily KETEK at 600 mg, Five Days A total of 120 patients were enrolled in the study and 116 patients who received at least one dose of study medication were assessed for clinical efficacy. Patients were aged between 19 and 89 years of age and had a confirmed diagnosis of acute upper RTI, community acquired pneumonia or acute bacterial exacerbation of chronic pulmonary disease. The clinical efficacy rate at the end of treatment and at test of cure was 92.7%, while the bacteriological efficacy by subject at end of treatment was 86%. The eradication rate of S. pneumoniae, the most frequently identified pathogen in the study, was 92.3%. Once Daily KETEK 600 mg vs. Levofloxacin three times daily in CAP A Phase III, double-blind, randomized, noninferiority comparative study, patients between 16 and 80 years of age with mild or moderate CAP, presumed to be caused by common (e.g., S. pneumoniae or H. influenzae) or atypical/intracellular (M. pneumoniae, C. pneumoniae or L. pneumophila) bacteria. The clinical efficacy rates for KETEK and levofloxacin were 93.3% and 90.0%, respectively, for infections caused by S. pneumoniae. For H. influenzae, rates in the KETEK and levofloxacin groups were 96.8% and 86.7%, respectively. In both studies all adverse events were either mild or moderate. About KETEK In July 2001, KETEK (800 mg oral dose once daily) received marketing approval in the European Union (EU) for the treatment of patients 18 years and older for CAP, mild or moderate; acute exacerbation of chronic bronchitis (AECB); acute sinusitis; and tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate, in patients 12 years and older. In Phase III studies, the most commonly reported adverse events associated with KETEK were diarrhea, nausea, dizziness and vomiting. Ketek was launch in October 2001 in Germany and is also available in such countries as Brazil, Mexico, Spain, and Italy. Aventis anticipates additional launches of Ketek in the coming weeks and months. In addition, in January the company filed a NDA for Ketek in Japan, the second largest antibiotic market worldwide. Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion, invested approx. € 3 billion in research and development and employed approx. 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 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. SOURCE: Aventis E-mail this page to a friend or colleague! To print, use this version