ECCMID: Ketek® (Telithromycin) Shown To Be More Effective Than Other Commonly Used Antibiotics
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ECCMID: Ketek® (Telithromycin) Shown To Be More Effective Than Other Commonly Used Antibiotics

Subanalyses Also Show Ketek® Highly Active Against Blood Isolates To Streptococcus Pneumoniae

MILAN, ITALY -- April 29, 2002 -- KETEK® (telithromycin) is more effective against clinical isolates of Streptococcus pneumoniae - including those strains that are resistant to penicillin and erythromycin - than several commonly used antibiotics including the macrolides clarithrmycin and azithromycin, according to data presented at the 12th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). A total of 394 clinical isolates of S. pneumoniae were obtained from adult patients with community acquired RTIs, including community acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB) and acute maxillary sinusitis (AMS). RTIs are the most common infections treated by healthcare practitioners and represent a significant societal burden, causing 50 million deaths globally each year.

All isolates showed intermediate or full susceptibility to KETEK - the first ketolide antibacterial to be approved for clinical use - while 58% of bacteria strains were resistant to clarithromycin and 61% were resistant to azithromycin. All 47 pneumococcal strains that were resistant to penicillin G remained susceptible to KETEK, but showed high levels of cross-resistance to both clarithromycin (63.8%) and azithromycin (68.1%). A total of 58 strains (14.7%) were resistant to erythromycin A, and nearly all of these strains were also resistant to clarithromycin and azithromycin (98.3%); none were resistant to KETEK.

KETEK has also been shown to have a low potential to select for resistance in vitro and does not induce MLSb resistance.

KETEK Active Against Blood Isolates
Twenty-five centers participating in the PROTEKT (Prospective Resistant Organism Tracking and Epidemiology of the Ketolide Telithromycin) study - which includes more than 500 centers worldwide - submitted S. pneumoniae and H. influenzae blood isolates from patients with community-acquired RTIs. Of the 502 S. pneumoniae isolates collected, 18.7% were resistant to penicillin and 21.3% were resistant to erythromycin, all of which were cross-resistant to clarithromycin and azithromycin. KETEK was the most potent of the other antibiotics tested. More importantly, KETEK was highly active against penicillin resistant blood isolates.

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

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