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Synthetic Biologics Initiates Development Of Monoclonal Antibodies For Treatment Of Acinetobacter Infections

ANN ARBOR, Mich., Sept. 18, 2012 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious diseases and unmet medical needs, today announced that it has initiated efforts to develop a monoclonal antibody (mAb) therapy for the treatment of acinetobacter infections. Many strains of Acinetobacter are multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected by natural disasters. The Company also announced that it has engaged Lewis (Lew) Barrett, former Assistant Vice President, Established Products at Pfizer and Vice President Global Business Manager, Infectious Diseases at Wyeth Pharmaceuticals, to bring his expertise in the development, commercialization and launch of infectious disease product candidates to the Synthetic Biologics' team.

Acinetobacter is a difficult to treat pathogen due to its rapid and well-established resistance to most antibiotics, making it a multidrug-resistant pathogen[1]. In addition, as a biofilm-forming pathogen, Acinetobacter has the ability to survive up to twice as long as non-biofilm-forming pathogens[2]. In the U.S., Acinetobacter has been reported to be the cause of up to 2.6% of hospital acquired infections, 1.3% of bloodstream infections and 7% of ICU respiratory tract infections[3], and more than half of the Acinetobacter isolates are multidrug-resistant[4]. Patients with infections caused by Acinetobacter have been reported having mortality rates ranging from 7.8% to 43% in the hospital and in the ICU[5]. While Acinetobacter is a well-documented pathogen in the hospital setting, this pathogen also poses an increasing danger to wounded servicemen and women in military treatment centers[6] and to those treated in trauma centers following natural disasters[7].

The initiation of mAb development for the treatment of acinetobacter infection is the first of the three initial targeted infectious diseases the Company intends to pursue as part of its most recent collaboration with Intrexon Corporation. In August 2012, Synthetic Biologics entered into a worldwide exclusive channel collaboration with Intrexon Corporation for the development and commercialization of mAb therapies to treat certain infectious diseases not adequately addressed by existing therapies. Under this collaboration, the Company intends to utilize Intrexon's comprehensive suite of proprietary technologies, including the mAbLogix™ and LEAP™ platforms, to develop fully human mAbs to specifically and rapidly neutralize/clear acinetobacter pathogens. The collaboration may optionally be expanded to include up to an additional five infectious disease indications.

"We are pleased to begin work on a mAb therapy to treat acinetobacter infections. Acinetobacter has developed an increased resistance to antibiotics and other drugs over time, and a new therapeutic option is needed to treat infectious diseases caused by this bacteria," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc. "Our collaboration with Intrexon provides access to state-of-the-art platforms that have tremendous potential to produce a broad spectrum of fully human antibodies to fight against Acinetobacter where other options have failed."

Mr. Riley concluded, "We welcome Lew Barrett to our team and look forward to benefiting from his many years of experience around the development and commercialization of anti-infectives, as we develop mAbs for the treatment of acinetobacter infections. We also look forward to disclosing additional infectious disease indications we intend to pursue in the near future."

During his 25-year career at Wyeth (acquired by Pfizer in 2009), Mr. Barrett successfully led, co-chaired or served as the senior marketing executive on teams that focused on infectious diseases, oncology, transplantation, and hemophilia. He brings to Synthetic Biologics his expertise in U.S. and global strategy, domestic/global branding, clinical development, medical affairs, supply chain, business development and strategic alliance management. He built the brand and led global commercialization efforts for Wyeth's in-line IV antibiotic, Zosyn®/Tazocin® (the second IV antibiotic to achieve $1 billion+ in sales), and managed the U.S. launch of Wyeth's broad-spectrum IV antibiotic, Tygacil®. In 2010, Mr. Barrett formed LL Barrett Biopharmaceutical Consulting, LLC, and utilizing his depth of experience in the anti-infective, hospital and biopharma fields, provides strategic consultation to the global life sciences field with a particular focus on brand strategy, lifecycle strategy, business development, and strategic communications.

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