Targanta Presents Efficacy and Safety Data for Oritavancin for the Treatment of Gram-Positive Complicated Skin and Skin Structure Infections (cSSSI)
Targanta Therapeutics Corporation (NASDAQ: TARG) today announced the presentation of key clinical findings of its lead antibiotic drug candidate, oritavancin, at the combined annual meetings of the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the 46th Infectious Disease Society of America (IDSA), taking place in Washington, DC. The presentations highlight the efficacy and safety results of two Phase 3 clinical studies of oritavancin.
Sunday, October 26, 2008 at 12:15 p.m. EDT
Oritavancin Demonstrated Efficacy with 3-7 Day Therapy in Two Phase 3 Trials for cSSSI
Poster L-1514 is entitled, “Oritavancin in the treatment of complicated skin and skin structure infections (cSSSI): Combined results of two Phase 3 multinational trials.” This presentation reviews the efficacy and safety results of two randomized, double-blind, multicenter, Phase 3 trials designed to test whether 3 to 7 days of oritavancin was non-inferior to 10 to 14 days of vancomycin/cephalexin in the treatment of gram-positive cSSSI, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Inclusion criteria allowed patients with diabetes, renal or hepatic insufficiency, and HIV/AIDS to be enrolled. In these studies, oritavancin demonstrated comparable efficacy to vancomycin. Oritavancin had a favorable safety profile compared to vancomycin with fewer patients experiencing adverse events (AEs) or discontinuation from the study due to an AE. Adverse events were generally mild to moderate in nature with nausea, headache and pruritis being the most common drug-related AEs in oritavancin patients, and pruritis and vomiting in vancomycin patients.
Oritavancin was Associated with Fewer Histamine-like Infusion Reactions Compared to Vancomycin
Poster L-1515 is entitled, “Incidence of Histamine-like Infusion Reactions (HLIR) in 2 Phase 3 studies comparing oritavancin with vancomycin in the treatment of complicated skin and skin structure infections.” Histamine-like infusion reactions are a well-recognized adverse effect of glycopeptide administration. This study assessed the frequency and nature of HLIRs in two randomized, double-blind phase 3 studies comparing oritavancin with vancomycin/cephalexin in the treatment of cSSSI. The study showed that when compared with vancomycin in the treatment of patients with cSSSI, oritavancin was associated with a lower incidence of HLIRs.
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 3 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 U.S. 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 the possible treatment of Clostridium difficile.
About Targanta Therapeutics
Targanta Therapeutics Corporation (Nasdaq: TARG) is a biopharmaceutical company focused on developing and commercializing innovative antibiotics to treat serious infections in the hospital and other institutional settings. The Company’s pipeline includes an intravenous version of oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently awaiting U.S. and EU regulatory approval, and a program to develop an oral version of oritavancin for the treatment of Clostridium difficile. The Company has operations in Cambridge, MA, Indianapolis, IN, and Montreal, Quebec, Canada. For more information on Targanta, visit www.targanta.com.
Safe Harbor Statement
This press release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These are statements that are predictive in nature, that depend upon or refer to future events or conditions or that include words such as “potential,”"may,”"will,”"expects,”"projects,”"anticipates,”"estimates,”"believes,”"intends,”"plans,”"should,”"seeks,”"hope” and similar expressions. Forward-looking statements involve known and unknown risks and uncertainties that may cause actual future results to differ materially from those projected or contemplated in the forward-looking statements. Forward-looking statements may be significantly impacted by certain risks and uncertainties described in Targanta’s filings with the Securities and Exchange Commission. The risks and uncertainties referred to above include, but are not limited to, delays in obtaining or a failure to obtain regulatory approval for Targanta’s product candidates; unfavorable clinical trial results; Targanta’s potential inability to initiate and complete pre-clinical studies and clinical trials for its product candidates; the possibility that results of pre-clinical studies are not necessarily predictive of clinical trial results; and those other risk factors that are described more fully in the Company’s filings with the Securities and Exchange Commission. Targanta does not undertake any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.