Targanta Therapeutics Corporation has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for its lead candidate, oritavancin, a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria.
The MAA seeks approval of oritavancin for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
As in Targanta's United States regulatory filing, the oritavancin MAA includes data from 19 clinical trials, including two pivotal phase III clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSTI (known in the US as complicated skin and skin structure infections, or cSSSI), both of which met their primary endpoints. The MAA dossier also includes data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, including a broad range of gram-positive strains resistant to commonly used antibiotics such as oxacillin, methicillin, vancomycin, daptomycin, and linezolid.
"Following our submission for US approval of oritavancin in February, we are very pleased to have achieved yet another projected and significant milestone for Targanta with this European submission," said Mark Leuchtenberger, president and chief executive officer of Targanta.
"Data from the European Antimicrobial Resistance Surveillance System (EARSS) indicate that the prevalence of MRSA, while different across countries, has been rising across Europe over the past decade. As such, we look forward to working with the EMEA to make oritavancin available throughout the European Union for the treatment of cSSTI in a timely manner".
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. In its intravenous (IV) formulation, the product candidate has been tested in over 2,100 individuals and has completed two phase III studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met.
Targanta submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI; the FDA accepted the NDA submission for standard review, establishing an action date of December 8, 2008. Targanta is also developing an oral version of oritavancin for possible treatment of Clostridium difficile-related conditions.
Targanta Therapeutics Corporation is a biopharmaceutical company focused on developing and commercializing innovative antibiotics to treat serious infections in the hospital and other institutional settings.