Surveillance Study Finds Newly-Approved Antibiotic KETEK(R) (telithromycin) Tablets 99% Effective In Vitro Against Streptococcus

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Surveillance Study Finds Newly-Approved Antibiotic KETEK(R) (telithromycin) Tablets 99% Effective In Vitro Against Streptococcus pneumoniae Bacteria - Multi-drug resistance common among isolates of Streptococcus pneumoniae in the United States - ORLANDO, Fla., May 23 /PRNewswire-FirstCall/ -- Results from an ongoing surveillance study, PROTEKT US (Prospective Resistant Organism Tracking and Epidemiology of the Ketolide Telithromycin - United States) Year 2 (2001- 2002), suggest that KETEK(R) (telithromycin) is highly active in vitro against Streptococcus pneumoniae (S. pneumoniae) isolates, including those resistant to other antimicrobial agents. These data were presented today at the 100th International Conference of the American Thoracic Society (ATS). Increasing multi-drug resistance among S. pneumoniae isolates compromises the treatment of community-acquired respiratory tract infections. This study found that nearly 30% (n=2,805) of S. pneumoniae isolates were resistant to several antibacterials, including penicillin, cefuroxime, erythromycin, clindamycin, levofloxacin, tetracycline and co-trimoxazole, while more than 99% (n=9,517) of S. pneumoniae isolates were susceptible to KETEK, irrespective of multi-drug resistance. A total of 242 centers submitted 9,531 S. pneumoniae isolates for the study. "The increasing incidence of multi-drug resistant S. pneumoniae poses a challenge in the management of community-acquired respiratory tract infections," said Steven Brown, PhD, of the Clinical Microbiology Institute, Wilsonville, Oregon and the lead author of the poster. "As results from PROTEKT US demonstrate, KETEK is active against these resistant strains of S. pneumoniae in vitro." About the Study Data from PROTEKT US were analyzed to determine the prevalence of multi- drug resistance (defined as resistant to > or equal to 2 antimicrobials) among S. pneumoniae isolates. A total of 9,531 S. pneumoniae isolates from bronchoalveolar lavage, blood, ear, nasopharyngeal swab/aspirate, sinus and sputum cultures were examined from patients in 242 centers across the United States. Isolates were studied for in vitro resistance to penicillin, cefuroxime, erythromycin, clindamycin, levofloxacin, tetracycline and co-trimoxazole. Study results found that 2,805 of the S. pneumoniae isolates were multi-drug resistant. Resistance to four antibacterials was the most common type of multi-drug resistance in all culture sources. The most common example of multi-drug resistance was resistance to penicillin, cefuroxime, erythromycin and co- trimoxazole, accounting for 74.6% of four antimicrobial resistance from bronchoalveolar lavage cultures, 85.9% from blood cultures, 73.4% from ear cultures, 76.0% from nasopharyngeal swab/aspirate cultures, 73.8% from sinus cultures and 69.1% from sputum cultures. Overall, 99.9% of the S. pneumoniae isolates were susceptible to KETEK, ranging from 99.4% (bronchoalveolar lavage cultures) to 99.9% (blood and sputum). About Streptococcus pneumoniae The pathogen S. pneumoniae, which accounts for more than 4 million deaths annually, is recognized as the most important pathogen of the respiratory tract in adults and is identified as the most common etiologic agent in community-acquired pneumonia (CAP) and acute bacterial sinusitis. Additionally, it is the pathogen most associated with morbidity and mortality and is identified in virtually all CAP studies, causing approximately two thirds of all cases of bacteremic pneumonia. Resistance to established antibiotics continues to grow, with penicillin and macrolide resistance rates for S. pneumoniae reported at 39% and 31%, respectively. About PROTEKT PROTEKT US is one of the largest surveillance studies in the United States, evaluating in its first year more than 17,000 pathogens in more than 206 sites across 44 states. The study was initiated in 2000 and was designed to monitor the spread of resistant phenotypes and genotypes of the major respiratory tract infection pathogens across the nation. It is an ongoing study that is a branch of a larger international study called PROTEKT, which altogether includes more than 500 centers in 35 countries worldwide. About KETEK(R) KETEK was recently approved by the U.S. Food and Drug Administration to treat community-acquired respiratory tract infections in patients age 18 and older with acute bacterial exacerbation of chronic bronchitis; acute bacterial sinusitis; and mild to moderate community-acquired pneumonia, including those infections caused by multi-drug resistant Streptococcus pneumoniae (MDRSP). In clinical trials, the most commonly reported side effects were nausea, headache, dizziness, vomiting, and diarrhea. About Aventis Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of 16.79 billion euros (US $18.99), invested 2.86 billion euros (US $3.24) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit: http://www.aventis-us.com/. Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant 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 and in the current Annual Report -- "Document de Reference" -- on file with the "Autorite des marches financiers" in France. DATASOURCE: Aventis CONTACT: Lise Geduldig, +1-908-243-6580, , or Melissa Feltmann, +1-908-243-7080, , both of Aventis US Product Communications Web site: http://www.aventis-us.com/

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