Televancin (Vibativ), a new antibiotic developed by Theravance and Astellas, to treat skin infections caused by the the toughest staphylococcus and methicillin-resistant bacteria has been granted approval by USFDA.
Telavancin (Vibativ) is a once-daily injectable lipoglycopeptide antibiotic. Televancin can be used for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible gram-positive bacteria, including staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains, announced its developers Theravance.
Theravance, Inc and Astellas Pharma US, Inc in a press statement.
Televancin injectable antibiotic has a dual mechanism of action whereby it both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
Televancin (Vibative) has demonstrated its efficacy and safety in clinical trials for the treatment of gram-positive complicated skin and skin structure infections which included the largest number of patients with methicillin-resistant Staphylococcus aureus studied to date,according to Ralph Corey, MD, Professor of Medicine at the Duke University Medical Center and the principal investigator in the ATLAS program.
Televancin’s (Vibativ) phase III clinical program consisted of two large, multinational, double-blind, randomized Phase III clinical studies, ATLAS I and ATLAS II designed to compare the efficacy and safety of televancin (10 mg/kg IV once daily) versus vancomycin (1 gm IV q 12hr) in adult patients with cSSSI caused by gram-positive bacteria.
A total of 1,867 patients were enrolled and treated, 719 of whom had infections with MRSA. In both of these studies, televancin achieved its primary endpoint of non-inferiority relative to the standard of care, vancomycin. Televancin has not been studied in children.
In the Phase III cSSSI clinical trials using televancin, serious adverse events were reported in 7% of patients treated with Vibativ and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% of vancomycin-treated patients, and most commonly included cardiac, respiratory, or infectious events.
Televancin (Vibativ) will be marketed and sold by Astellas and is expected to be commercially available in the United States during the fourth quarter of 2009. Theravance will collaborate with Astellas in marketing in the United States for the first three years following approval, the release said.
Theravance is a biopharmaceutical company with a pipeline of product candidates for respiratory disease, bacterial infections and gastrointestinal motility dysfunction. The company’s key programs include: Vibativ with Astellas Pharma Inc. and the Horizon program and Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program with GlaxoSmithKline plc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. In the US, Astellas markets products in the areas of immunology, urology, anti-infectives, cardiovascular and dermatology.
In November 2005, Theravance entered into a collaboration arrangement with Astellas Pharma Inc. for the development and commercialization of Vibativ worldwide except Japan. In July 2006, Theravance and Astellas expanded the collaboration to include Japan.
Under the terms of the collaboration, Theravance is responsible for the development of and US FDA filings for televancin for the treatment of (i) complicated skin and skin structure infections and (ii) nosocomial pneumonia. Theravance is also responsible for the manufacture of approximately six months of first commercial sale stock for launch of VIBATIV in the United States.
Astellas is responsible for all other development, regulatory, manufacturing, sales and marketing activities. Theravance will collaborate with Astellas in marketing in the United States for the first three years following approval.