Targanta Therapeutics Corporation announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorization Application (MAA) 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 (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Targanta announced the submission of its MAA for oritavancin to EMEA on June 9, 2008.
"With the acceptance for review of our United States regulatory filing for oritavancin earlier this year, closely followed by this EMEA acceptance for review, we are proud to have achieved these planned operational milestones and we are now in the position of planning for the commercial launch of oritavancin in the US and European markets," said Mark Leuchtenberger, President and CEO of Targanta. "If regulatory discussions progress as anticipated and approval is received, we expect to launch oritavancin in the US in the first half of 2009. Given the standard regulatory review times in the EU, we hope to receive approval for oritavancin in late 2009".
Mona Haynes, Targanta's chief commercial officer, commented further on the need for new agents in the EU, "As in the US, serious gram-positive infections are increasing and provide challenges to healthcare professionals. We are excited at the possibility of bringing clinicians another option to use in patients with these difficult-to-treat infections".
The oritavancin MAA includes data from 19 clinical trials, including two pivotal phase III clinical trials examining the safety and efficacy of intravenous 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.
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 2,400 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's marketing authorization application (MAA) for oritavancin was accepted for review by the European Medicines Agency (EMEA) in June 2008. Targanta is also developing an oral version of oritavancin for possible treatment of Clostridium difficile-related conditions.