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Synthetic Biologics Initiates Manufacturing Process For C. Difficile Infectious Disease Program

Stocks in this article: SYN

ROCKVILLE, Md., July 18, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases, announced today the initiation of the manufacturing process of the Company's proprietary beta-lactamase enzyme (SYN-004) to target the prevention of Clostridium difficile (C. difficile or C. diff) infections. Pursuant to an agreement with FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm), the initial phase of the SYN-004 manufacturing process is underway with the evaluation of beta-lactamase protein expression in Fujifilm's pAVEway™ platform. SYN-004 will be evaluated for production cell line yields as well as biological activity of the enzyme product.

"Initiating this expression platform evaluation with Fujifilm is an important first step in the SYN-004 manufacturing process. These efforts move us toward our goal of developing a prophylactic to prevent the devastating effects of C. diff infections, for which there is currently no vaccine or other approved preventive therapy," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Upon completion of production cell line evaluation and selection of the optimal expression clone, we intend to proceed rapidly with manufacturing of preclinical material for animal studies, and cGMP production of SYN-004 for clinical studies."

Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies UK Limited said, "We are excited to have the opportunity to demonstrate to Synthetic Biologics the versatility of our pAVEway™ expression system for SYN-004 production."

SYN-004: Targeting the Prevention of C. difficile Infections

In November 2012, Synthetic Biologics, Inc. acquired a series of oral beta-lactamase enzymes (P1A, P2A and P3A) and related assets targeting the prevention of C. difficile infections (CDI), the leading cause of hospital acquired infections (HAI), that generally occur secondary to treatment with intravenous antibiotics. The acquired assets include a pre-Investigational New Drug (IND) package for SYN-004, a 2 nd generation oral enzyme candidate (formerly known as Ipsat Therapeutics P3A); Phase I and Phase II clinical data for P1A (a 1 st generation oral enzyme candidate); manufacturing processes and data; and, a portfolio of issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the U.S. Food and Drug Administration.

Utilizing this portfolio of assets, the Company intends to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with certain intravenous 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. Beta-lactam antibiotics are a mainstay in hospital infection management and include the commonly used penicillin and cephalosporin classes of antibiotics. In 2012, 15 million Americans were administered beta-lactam antibiotics.*

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