Targanta Therapeutics (TARG) Announces EMEA Accepts Review for Oritavancin

June 25, 2008 7:33 AM EDT

Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that the European Medicines Agency has accepted for review its Marketing Authorization Application for oritavancin, Targanta's novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria.

Targanta is seeking approval of intravenous oritavancin in the European Union for the treatment of complicated skin and soft tissue infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. Targanta announced the submission of its MAA for oritavancin to EMEA on June 9, 2008.

The oritavancin MAA includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of intravenous oritavancin in the treatment of cSSTI, 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.

Targanta Therapeutics Corporation, together with its subsidiaries, operates as a biopharmaceutical company that focuses on developing and commercializing antibacterial drugs to treat serious infections in hospital and other institutional settings.

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