Aventis Launches New Antibiotic
INNOVATIVE KETOLIDE ANTIBIOTIC TO COMBAT COMMUNITY-ACQUIRED RESPIRATORY TRACT INFECTIONS (CARTIs)
04-Feb-2002
Frankfurt, Germany, February 1, 2002 - Ketek® (telithromycin), the world's first ketolide antibiotic to reach the market, was recently launched in two additional European countries, Spain and Italy. This follows the very successful initial launch of Ketek in Germany last October. Ketek achieved an impressive 8% market share in Germany in just 8 weeks on the market. It has also matched what was considered the most successful recent antibiotic launch ever in Germany at this early point in its market life.
Ketek (800 mg oral dose once daily) is specifically 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. The labeling includes the in vivo claim regarding Ketek's efficacy against drug resistant Streptococcus pneumoniae. Ketek is well tolerated and shows a safety profile comparable to currently used antibiotics. In phase III studies, the most commonly reported adverse events associated with Ketek were diarrhea, nausea, dizziness and vomiting.
Ketek was 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, 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.
"We are very proud of the early success Ketek is receiving in Germany and we look forward to achieving the same success in Spain, Italy and other countries in which we expect to launch this important antibiotic", said Frank Douglas, MD, PhD., Executive Vice President and Head of Drug Innovation & Approval at Aventis Pharma. "Ketek is a highly innovative agent with major potential advantages over other antibiotic classes used to treat respiratory tract infections", he added.
The European Commission granted marketing authorization for Ketek in July 2001. Ketek was approved for the treatment of community-acquired upper and lower respiratory tract infections, including those caused by bacteria resistant to commonly used antibiotics. Ketek was recently launched in Mexico and Aventis anticipates additional launches of Ketek in the coming weeks and months. In addition, the company recently filed a NDA for Ketek in Japan, the second largest antibiotic market worldwide. In the U.S., following notification from the FDA in June of 2001 stating that Ketek was approvable for three indications: community-acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (ABECB), and acute bacterial sinusitis; and not approvable for tonsilitis/pharyngitis, the company and the FDA have agreed upon additional clinical data and experience that are necessary to support the approval of Ketek for the three approvable indications. Aventis has already begun enrolling patients in these studies, and has targeted mid-2002 for the submission of these additional data.
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