Targanta Therapeutics announces posting of briefing documents for review of FDA

Nov 18 2008

Targanta Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the November 19, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting.

AIDAC will review Targanta's New Drug Application (NDA) for oritavancin for the treatment of complicated skin and skin structure infection (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus , or MRSA.

Briefing documents from FDA and Targanta can be found on FDA's website at http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4394b2-00-Index-FDA.htm.

About Oritavancin

Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria, including methicillin-resistant Staphylococcus aureus , or MRSA. These types of resistant infections have created a market that IMS Health estimated to be over one billion dollars in the U.S. in 2007 and growing rapidly. In its intravenous (IV) formulation, the product candidate has been tested in over 1,900 individuals and has completed two Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met. The NDA dossier 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. FDA's action date for the oritavancin NDA is December 8, 2008.