Candidate Represents Potential New Short-Course Treatment Option for
Serious Gram-Positive Skin Infections, Including MRSA
CAMBRIDGE, Mass., Feb. 11 /PRNewswire-FirstCall/ -- Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead antibiotic candidate, oritavancin, a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria.
Oritavancin would be indicated for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Targanta believes oritavancin's properties may offer distinct advantages in treating patients who have these serious infections.
The oritavancin NDA submission includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSSI, both of which met their primary endpoints. The NDA 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.
"The NDA submission is a significant milestone for Targanta," said Mark
Leuchtenberger, president and chief executive officer of Targanta. "We are
proud to have taken this important first step towards providing the
infectious disease community with a new candidate to combat the growing
|SOURCE Targanta Therapeutics Corporation|
Copyright©2008 PR Newswire.
All rights reserved