KETEK highly active in vitro against European isolates of community-acquired respiratory pathogens

July 03, 2001

Amsterdam, The Netherlands, 3 July 2001 - A novel investigational antibiotic has demonstrated excellent in vitro activity against European isolates of community acquired respiratory pathogens. In vitro data from the international PROTEKT (Prospective Resistant Organism Tracking and Epidemiology for the Ketolide Telithromycin) study presented today at the 22nd International Congress of Chemotherapy (ICC), in Amsterdam, The Netherlands, suggest that KETEKÒ (telithromycin) is an effective option for the treatment of community-acquired respiratory tract infections (CARTIs).

CARTIs are the most common infections treated by healthcare practitioners and represent a significant societal burden, causing 50 million deaths globally each year. As part of the worldwide PROTEKT study, bacterial isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pyogenes and Staphylococcus aureus were collected from patients with CARTIs, from 14 centres from France, Germany and Italy.

The overall penicillin resistance level among pneumococci was 16.1 percent, with France showing the highest incidence. Erythromycin resistance levels among S. pneumoniae (33.9 percent) exceeded penicillin resistance levels in each country. For S. pyogenes and S. aureus, the incidence of erythromycin resistance was 26.8 percent and 14.8 percent, respectively. KETEK was among the most active agents tested against Gram-positive cocci, with 99.6 percent of pneumococcal isolates susceptible. KETEK's activity against H. influenzae was equivalent to that of azithromycin and eight-fold greater than that of clarithromycin.

Macrolide resistance study
Also presented was a study that compared macrolide resistance mechanisms in clinical isolates of S. pneumoniae collected in the PROTEKT study from Japan, France and Italy which all have high-prevalence macrolide resistance, (80.2 percent), (55 percent) and (48.2 percent), respectively.

The study revealed that it took less than 1mg/L for KETEK to eradicate >99 percent of the macrolide-resistant isolates. The data shows that the distribution of macrolide resistance mechanisms varies widely between countries even when the countries are in close proximity.

A third study presented at ICC looked at clinical isolates of pneumococci and S. pyogenes from 10 central and eastern European countries that were tested for macrolide resistance and KETEK susceptibility.

The study concluded that the predominant mechanism of macrolide resistance was erm-mediated methylation for both pneumoccocci and S. pyogenes. KETEK was active against 98.9 percent and 99 percent of all pneumococcal and S. pyogenes isolates, respectively.

PROTEKT data include isolates from countries spanning North America, Europe, Latin America and the Asia Pacific. PROTEKT involves 72 laboratories in 25 countries. It is an ongoing study, where researchers analyse the susceptibility of seven common and atypical community-acquired respiratory tract infectionI-causing bacteria to most current treatments including penicillins such as amoxicillin, cephalosporins and commonly used macrolides such as azithromycin and clarithromycin as well as quinolones such as levofloxacin, moxifloxacin and gatifloxacin.

KETEK is the first in a new class of antibiotics called ketolides that has been developed specifically to offer optimal coverage in upper and lower respiratory tract infections including those caused by resistant pathogens with a short and reliable once-daily regimen.

In March of this year, Aventis received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP), the scientific body of the European Medicines Evaluation Agency (EMEA) recommending the granting of a marketing authorisation for KETEK for use in treating community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB), acute sinusitis and tonsillitis/pharyngitis. Additionally, the U.S. Food and Drug Administration (FDA) recently granted an approvable letter for KETEK for community-acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (ABECB), and acute bacterial sinusitis (ABS).
Aventis (NYSE: AVE), a world leader in pharmaceuticals and agriculture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales of 22.3 billion euros and employed approximately 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany, and Rhône-Poulenc SA of France. Corporate headquarters are in Strasbourg, France. For more information, please visit:

Aventis Pharma AG is the pharmaceutical company of Aventis. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and central nervous system disorders. Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis Pharma encompasses Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins headquartered in King of Prussia, Pennsylvania, USA.

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.

Ketchum UK

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