The study, presented today at the 22nd International Congress of Chemotherapy (ICC), in Amsterdam, The Netherlands, involved an analysis of data from Phase III studies of KETEK -- the first in a new class of antibiotics called ketolides.
The efficacy of KETEK 800 mg once daily was assessed in 955 patients between the ages of 18 and 65 with signs, symptoms and radiological confirmation of CAP in five clinical trials. Blood samples were taken pre-therapy for aerobic and anaerobic culture. Clinical and bacteriological outcomes were assessed seven to 11 days after the treatment was finished. Forty-seven (4.9 percent) of the KETEK-treated patients with CAP had documented pneumococcal bacteraemia at baseline. The clinical cure rate was 89.5 percent, with a bacterial eradication rate post therapy of 89.5 percent.
Bacteraemia occurs in up to 30 percent of patients with pneumococcal pneumonia and represents a significant factor for morbidity.
KETEK safety and tolerability studies Also presented today were the results of the safety and tolerability of KETEK in more than 1800 adults with community-acquired respiratory tract infections (CARTIs) in eight randomised, double-blind comparator-controlled studies.
Patients received KETEK 800 mg once daily for five or seven to 10 days or a comparator (clarithromycin, amoxicillin ± clavulanate, cefuroxime axetil or penicillin V [for 10 days] or trovafloxacin [seven to 10 days]). 677 (35.8 percent) of the KETEK-treated patients reported at least one treatment-emergent adverse event (TEAE) considered possibly related to the study treatment. The most commonly reported TEAEs were diarrhea, nausea, dizziness and vomiting. The majority of the events were mild or moderate in intensity, with few resulting in treatment discontinuations (4.0 percent).
KETEK 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 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 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: www.aventis.com.
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.
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