ECCMID: Ketek Shown To Be More Active Than Commonly Used Antibiotics In Children With Community-Acquired Respiratory Tract Infections
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ECCMID: Ketek Shown To Be More Active Than Commonly Used Antibiotics In Children With Community-Acquired Respiratory Tract Infections

MILAN, ITALY -- April 30, 2002 -- KETEK® (telithromycin), the first ketolide antibacterial approved for clinical use, is more active than several commonly prescribed antibiotics for the treatment of pediatric community-acquired respiratory tract infections, according to PROTEKT (Prospective Resistant Organism Tracking and Epidemiology of the Ketolide Telithromycin) studies presented at the 12th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The in vitro data showed that KETEK is highly active against Streptococcus pneumoniae and Haemophilus influenze isolates - the bacteria strains most often associated with pediatric RTIs - that are resistant to penicillin and the macrolide antibiotic erythromycin.

Community acquired respiratory tract infections (RTIs) are the most common infections treated by healthcare practitioners and represent a significant societal burden, causing 50 million deaths globally each year.

Study Results
During the 1999-2000 respiratory season, 69 centers from 25 countries participated in the PROTEKT study. In total, 802 S. pneumoniae isolates were collected from children aged 0-14 years with CARTIs. These isolates were submitted by 51 centers in 20 countries. KETEK was the most potent of the antibiotics tested with 99.6% of isolates being inhibited. In addition, KETEK was highly active against penicillin resistant blood isolates. Overall, 42.8% of S. pneumoniae showed reduced susceptibility to penicillin, with prevalence highest in children two years or younger. The overall resistance prevalence of erythromycin was 35.9%, with prevalence highest in children two years or younger.

In a second study, a total of 56 isolates of H. influenzae and 100 isolates of S. pneumoniae were obtained from pediatric patients with CARTIs. The average age of the children with H. influenzae and S. pneumoniae infections were 2.8 and 2.1 years respectively. KETEK demonstrated activity against H. influenzae and S. pneumoniae isolates compared to clarithromycin, azithromycin and rokitamycin. KETEK also was shown to be highly effective against penicillin resistant strains of the infections.

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. KETEK is not approved for use in children. 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 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

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