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Synthetic Biologics Reports Year End 2012 Financial Results
Date:4/16/2013

ROCKVILLE, Md., April 16, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases, today reported financial results for the year ended December 31, 2012 and summarized recent operational highlights.

Operational Highlights:Expanding Infectious Disease Portfolio

  • C. difficile Infections:
  • Utilizing our portfolio of beta-lactamase enzymes we acquired in November 2012, we intend to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004 (formerly Ipsat P3A), for the prevention of C. difficile infections (CDI). When co-administered with certain intravenous (IV) beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic that is excreted in the gastrointestinal (GI) tract, thus preserving the natural balance of the patient's microflora, and preventing opportunistic infections including CDI and antibiotic-associated diarrhea (AAD).
  • Animal studies of P1A (the first generation candidate) showed that C. difficile colonization and disease could be prevented in mouse models and that colonization by resistant bacteria could also be prevented. P1A was shown to be safe and well tolerated in a Phase I study. In addition, two Phase II clinical studies demonstrated that P1A had the ability to preserve GI microflora in hospitalized patients treated with IV ampicillin or the combination of piperacillin and tazobactam.
  • Compared to P1A, we believe that SYN-004 will have activity against a broader spectrum of beta-lactam antibiotics, including both penicillins and most cephalosporins.
  • According to GlobalData, an estimated 8.7 million Americans were administered IV beta-lactam antibiotics in 2011.
  • Pertussis:
  • In December 2012, in collaboration with Intrexon Corporation (Intrexon), we initiated development of a
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  • SOURCE Synthetic Biologics, Inc.
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