Ketek® (telithromycin), the first in a new class of antibiotics called ketolides, has been granted marketing authorisation by the European Commission for the treatment of community-acquired respiratory tract infections, including those caused by bacteria resistant to commonly used antibiotics.
Commission approval of the centralised application for Ketek results in a single marketing authorisation with unified labeling that is immediately valid in all 15 European Union (EU)-Member States.
Ketek (800 mg oral dose once daily) has been approved for the treatment of patients 18 years and older for community-acquired pneumonia (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.
This approval follows a positive opinion from the Committee for Proprietary Medicinal Products (CPMP), the scientific body of the European Medicines Evaluation Agency (EMEA) in March of this year.
"As bacteria increasingly become resistant to commonly used antibiotics, Ketek comes at a critical time," explained Dr Martin Wood, President of the British Society for Antimicrobial Chemotherapy, Birmingham, UK. "Globally, the search to find more effective agents to treat these potentially serious infections has continued. Phase III data has proven that Ketek has efficacy against key respiratory pathogens, including resistant strains of Streptococcus pneumoniae, the most common pathogen associated with community-acquired respiratory tract infections."
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. Ketek, as the first ketolide to reach the market, is a novel addition to the macrolide-lincosamide-streptogramin (MLSb) group of antibiotics. In vitro data (which don't necessarily correlate to clinical response) suggest that Ketek combats resistant bacteria by inhibiting the protein synthesis necessary for bacterial reproduction by binding at two different sites on bacterial ribosomes and by inhibiting the ribosome assembly.
"Ketek has many benefits for patients and physicians, particularly those in primary care," Dr. Wood continued, "We now have an antibiotic that, when taken once a day, works quickly and effectively against respiratory pathogens."
Ketek will first be launched in Germany and should be available later this year. Aventis anticipates extending the launch of Ketek throughout Europe as soon as is possible.
"We are very pleased with the Commission's decision to approve Ketek," said Frank Douglas, MD, PhD., Executive Vice President and Head of Drug Innovation & Approval at Aventis Pharma. "Ketek represents a prime example of Aventis' relentless commitment to developing next generation antibiotic therapies and raising awareness of the growing problem of worldwide antibiotic resistance."
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 and employed around 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: http://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 the 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 statement 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.