FDA Issues Complete Response Letter for Oritavancin

  
    
  
  
    
      Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that it 
      has received a Complete Response Letter from the U.S. Food and Drug 
      Administration (FDA) regarding its New Drug Application (NDA) for 
      oritavancin for the treatment of complicated skin and skin structure 
      infections (cSSSI).
    
    
      The FDA indicated in its letter that they cannot approve the application 
      for oritavancin in its current form and will require Targanta to perform 
      an additional well-controlled clinical study to demonstrate efficacy and 
      safety in order to gain approval. The FDA requested that a sufficient 
      number of patients with methicillin-resistant Staphylococcus aureus 
      (MRSA) as the cause of cSSSI be enrolled in the study to demonstrate the 
      effectiveness of oritavancin in this subset of patients. The FDA further 
      suggested that the clinical study evaluate the effect of oritavancin on 
      macrophage function and monitor for the potential for subsequent 
      infections that could possibly be related to macrophage dysfunction due 
      to the long terminal half-life of oritavancin. The FDA also requested 
      that the clinical study collect additional information on phlebitis 
      rates.
    
    
      In its letter to Targanta, the FDA stated the Company’s NDA did not 
      demonstrate the safety and efficacy of oritavancin for treatment of 
      cSSSI. The FDA reasoned that ARRI, the second and larger of two Phase 3 
      clinical studies which met a 10% non-inferiority margin, provided 
      evidence of activity of oritavancin but did not provide substantial 
      evidence alone or in combination with ARRD, the smaller of two Phase 3 
      clinical studies, to support the efficacy and safety of oritavancin. 
      Regarding ARRD, the FDA determined that the study did not provide 
      sufficient evidence of activity because the 95% confidence interval 
      between oritavancin and vancomycin was not less than 10%. FDA also 
      mentioned that, in ARRI, oritavancin did not appear to perform well in 
      patients with MRSA and, in ARRD, the number of patients with MRSA was 
      insufficient to address the performance of the drug candidate in 
      treating these patients.
    
    
      The FDA mentioned several safety findings from the two pivotal studies 
      for cSSSI including the higher rate of study discontinuations for lack 
      of efficacy among oritavancin-treated patients, the greater number of 
      oritavancin-treated patients who died or had a serious adverse event of 
      sepsis, septic shock and related events, and more oritavancin-treated 
      patients who experienced adverse events of osteomyelitis and other 
      sepsis.
    
    
      Oritavancin is a novel, semi-synthetic lipoglycopeptide antibiotic 
      candidate with potent bactericidal (killing) activity against a broad 
      spectrum of gram-positive bacteria. The oritavancin NDA submission 
      included 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 included 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.
    
    
      CONFERENCE CALL & WEBCAST INFORMATION
    
    
      Targanta will host a conference call and live audio webcast to discuss 
      the complete response letter for oritavancin.
    
    
      WHEN: December 9, 2008 at 8:30 a.m. ET
    
    
      LIVE DOMESTIC & CANADA CALL-IN: 877-407-9210LIVE INTERNATIONAL 
      CALL-IN: 201-689-8049
    
    
      24-HOUR REPLAY DOMESTIC & CANADA: 1-877-660-685324-HOUR REPLAY 
      INTERNATIONAL: 1-201-612-7415REPLAY PASSCODES (BOTH REQUIRED 
      FOR PLAYBACK):ACCOUNT #: 286, CONFERENCE ID #: 305896
    
    
      The call will also be webcast live, listen only, via the internet at: www.targanta.com.Replay 
      will be available on Targanta’s website for 30 days.
    
    
      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 EU regulatory approval, and a program to develop an oral 
      version of oritavancin for the possible treatment of Clostridium 
      difficile-related infection. 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 “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.