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Synthetic Biologics to Acquire Clinical-Stage C. difficile Infectious Disease Program
Date:11/12/2012

ROCKVILLE, Md., Nov. 12, 2012 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the Company has entered into an agreement with Prev AbR LLC to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile (C. diff) infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. The assets include a pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA.

Beta-lactamase enzymes have the ability to degrade beta-lactam antibiotics that may be excreted into the GI tract. Beta-lactam antibiotics are a mainstay in hospital infection management and include both penicillins and cephalosporins. In 2011, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics.[1] Utilizing the acquired biologic compounds, Synthetic Biologics intends to develop and commercialize a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with beta-lactam antibiotics in a hospital setting, it is expected that SYN-004 can preserve a patient's gastrointestinal (GI) microflora, thus preventing opportunistic C. diff infection (CDI).

C. diff Infection

In 2009, aggregate costs associated with CDI-related stays in the hospital were $8.2 billion in the U.S.[2] CDI is a global HAI in which the toxins produced by C. diff bacteria result in diarrhea (C. diff-associated diarrhea (CDAD)), and in the most serious cases, pseudomembranous colitis (erosion of the GI tract) that can lead to death. A major, unintended risk in the use of syste
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SOURCE Synthetic Biologics, Inc.
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