Targanta Completes Enrollment in Phase 2 Oritavancin Infrequent Dosing Study

  
    
  
  
    
      Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that 
      enrollment has been completed in its Phase 2 trial investigating the 
      safety and efficacy of oritavancin at Single or Infrequent 
      Doses for the Treatment of Complicated Skin and Skin Structure Infections 
      (cSSSI), or SIMPLIFI. Oritavancin is Targanta’s 
      lead antibiotic candidate targeting gram-positive infections.
    
    
      Mark Leuchtenberger, President and Chief Executive Officer of Targanta, 
      commented on the event: “We are very pleased 
      to have completed enrollment in SIMPLIFI on schedule and are looking 
      forward to locking the database and analyzing the results over the next 
      few months. We are optimistic that we will have data ready to submit to 
      one of the major infectious disease meetings this fall and will be using 
      these data to determine whether to pursue Phase 3 registration trials 
      for infrequent dosing of oritavancin in the treatment of cSSSI.”
    
    
      “As discussed previously,” 
      Mr. Leuchtenberger continued, “we believe 
      that, if demonstrated effective in pivotal, controlled trials and 
      subsequently approved by regulatory authorities, a less frequent dosing 
      regimen for oritavancin could be a major advantage to the infectious 
      disease community by providing flexible patient treatment options and 
      could also confer pharmacoeconomic benefits through shorter hospital 
      stays and reduced use of hospital resources.”
    
    
      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 has accepted the NDA 
      submission for standard review, establishing an action date of December 
      8, 2008.
    
    
      About SIMPLIFI
    
    
      This Phase 2 study is an international, multi-center, randomized, 
      double-blind, controlled study in patients with cSSSI presumed or proven 
      to be caused by gram-positive pathogen(s). The study consisted of three 
      treatment arms in which patients received either:
    
    
      
        200 mg oritavancin delivered by intravenous (IV) administration daily 
        for a minimum of 3 days and up to a maximum of 7 days (the dosing 
        regimen used in the larger of the two completed Phase 3 studies of 
        oritavancin in cSSSI and currently under review by U.S. regulatory 
        authorities);
      
      
        A single dose of 1200 mg oritavancin IV; or
      
      
        A single dose of 800 mg oritavancin IV, with a further dose of 400 mg 
        IV on Day 5, if needed.
      
    
    
      As its primary endpoint, SIMPLIFI is measuring clinical response (either 
      cure or improvement versus failure) in clinically evaluable patients. As 
      a secondary endpoint, this study is examining safety data in all 
      intent-to-treat patients. Over 300 patients were enrolled in the study.
    
    
      About Oritavancin
    
    
      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 2,100 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 to the U.S. Food and Drug 
      Administration in February 2008 seeking to commercialize IV oritavancin 
      for the treatment of cSSSI and believes oritavancin's properties may 
      give it distinct advantages in the treatment of serious gram-positive 
      skin infections, if approved. Targanta is also developing an oral 
      version of oritavancin for possible treatment of Clostridium difficile-related 
      conditions.
    
    
      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. regulatory approval, a program to 
      develop an oral version of oritavancin and a number of antibacterial 
      agents in pre-clinical development. The Company has operations in 
      Cambridge, MA, Indianapolis, IN, and Montreal, Québec, 
      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 “may,” "will," 
      "expects," "projects," "anticipates," "estimates," "believes," 
      "intends," "plans," "should," "seeks," and similar expressions. Such 
      statements include, the availability of the results of the SIMPLIFI 
      trial for submission to an infectious disease meeting in the fall of 
      2008; the pursuit of Phase 3 registration trials for infrequent dosing 
      of oritavancin in the treatment of cSSSI; and the provision of flexible 
      treatment options and the achievement of pharmacoeconomic benefits from 
      shorter hospital stays and reduced use of hospital resources resulting 
      from a less frequent dosing regimen for oritavancin. 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, risks related to 
      delays in obtaining or a failure to obtain regulatory approval for 
      Targanta’s product candidates; failure of any 
      approved product to achieve significant commercial acceptance in the 
      medical community or receive reimbursement by third-party payors; 
      unfavorable clinical trial results; competition from other 
      pharmaceutical or biotechnology companies; and those other risks 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.