Synthetic Biologics Appoints Raymond Stapleton, PhD, as Senior Vice President, Manufacturing

— Manufacturing Executive Served Most Recently in Leadership Positions at Merck &Co. —

— Appointment Reflects Company’s Focus on Preparing for Late-Stage Clinical Trials —

ROCKVILLE, Md., Oct. 1, 2015 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, announced that Raymond D. Stapleton, PhD, has joined the Company as Senior Vice President, Manufacturing. Dr. Stapleton will lead the manufacturing team as the Company begins to prepare for late-stage clinical trials for its irritable bowel syndrome with constipation (IBS-C) and C. difficile programs, and continues to move its monoclonal antibody (mAb) program forward to address Pertussis (whooping cough).

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Dr. Stapleton is a pharmaceutical and biotechnology executive with over 15 years of experience at Merck & Co., Inc., in manufacturing, operations, quality, science, technology, engineering and process development. He most recently served as Executive Director, Global Vaccine Technology and Engineering. During his tenure at Merck, Dr. Stapleton contributed to the scale up, tech transfer and manufacturing product launch of multiple billion dollar franchises including ISENTRESS® (oral solid dosage for AIDs), GARDASIL® (HPV vaccine), KEYTRUDA® (anti-PD-1 cancer mAb therapy), and performed process development for the cholesterol lowering therapy MEVACOR® (lovastatin).

“Ray’s comprehensive manufacturing experience with both small and large molecules, as well as monoclonal antibodies, makes him the ideal candidate to join our team as we prepare to move our microbiome programs further along in the clinic,” said Jeffrey Riley, Chief Executive Officer at Synthetic Biologics. “His accomplishments in manufacturing and operations, as well as his education in the areas of microbiology and the microbiome, are expected to be beneficial additions to Synthetic Biologics’ continued successful product development. We believe Ray’s knowledge of manufacturing processes to support the commercialization of products, will be valuable as our team advances the SYN-010 therapeutic program to address IBS-C and the SYN-004 program to protect the microbiome and prevent C. difficile infection and antibiotic-associated diarrhea.”

Dr. Stapleton earned a PhD in microbial ecology from The Center for Environmental Biotechnology at The University of Tennessee, Knoxville, and a BS degree in biology from Mary Washington College. Subsequently, he was the recipient of an Alexander Hollaender Fellowship for post-doctoral studies in the Environmental Science Division at Oak Ridge National Laboratory. Dr. Stapleton has served for 10 years as a member of the Journal of Industrial Microbiology and Biotechnology review board and is an ad hoc reviewer for several journals including Environmental Science and Technology, Antonie von Leeuwenhook, and Enzyme and Microbial Technology. He has co-edited a book, and co-authored patents, as well as several peer-reviewed manuscripts and presentations.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE: XON), a monoclonal antibody combination for the treatment of Pertussis and biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at

ISENTRESS®, GARDASIL®, KEYTRUDA® and MEVACOR® are registered trademarks of various subsidiaries of Merck & Co., Inc.

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the expected contribution of Dr. Stapleton, including his knowledge of manufacturing processes and his expected beneficial addition to Synthetic Biologics’ continued successful product development. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure to successfully integrate the new management and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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SOURCE Synthetic Biologics, Inc.