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Synthetic Biologics Announces Granting of U.S. Composition of Matter Patent for SYN-005, Designed for the Treatment and Prevention of Pertussis (Whooping Cough)

- Granted Patent Provides Composition of Matter Protection for SYN-005 to at Least 2035 -

ROCKVILLE, Md., Dec. 13, 2016 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics focused on the gut microbiome, today announced that the United States Patent Office has granted U.S. Patent No. 9,512,204 which provides composition of matter coverage for SYN-005, the Company's preclinical drug candidate designed to treat or prevent the development of Pertussis (whooping cough), especially in infants. This patent, which is co-owned with Synthetic Biologics' Pertussis academic collaborator, The University of Texas at Austin (UT Austin), is also exclusively licensed to Synthetic Biologics. The patent covers, among others, the Company's monoclonal antibody, hu1B7, a component of SYN-005 which is the subject of an ongoing study funded by a grant from the Bill & Melinda Gates Foundation to UT Austin. The exclusivity provided by this new patent has an expiration date of 2035, which does not include a potential patent term extension.

"The successful granting of this key composition of matter patent is an important milestone for SYN-005, our preclinical product candidate with orphan-drug designation designed to target and neutralize Pertussis toxin for the treatment of whooping cough," said Jeffrey Riley, President and Chief Executive Officer. "This patent issuance further strengthens our robust intellectual property portfolio and is an important component to the advancement and clinical development of this novel therapeutic."

Synthetic Biologics is developing SYN-005 through its Exclusive Channel Collaboration with Intrexon Corporation (NYSE: XON) and academic researchers at The University of Texas at Austin to target and neutralize the pertussis toxin in order to reduce morbidity and mortality in infected infants. Pertussis, more commonly known as whooping cough, is a highly contagious disease caused by the bacteria Bordetella pertussis (B. pertussis) with symptoms that may include chronic coughing and subsequent breathing difficulties. According to the World Health Organization, there are approximately 50 million worldwide cases of whooping cough each year, leading to an estimated 300,000 deaths, primarily among young, unvaccinated infants. In September 2014, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the Company's proprietary SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage clinical company developing therapeutics focused on the gut microbiome. The Company's lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.    

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, and include statements regarding the further strengthening of the patent estate, and the intended benefit of SYN-010, ribaxamase and SYN-005. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, Synthetic Biologics' product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics' ability to initiate clinical trials and if initiated, to complete them on time and achieve desired results and benefits, Synthetic Biologics' clinical trials continuing enrollment as expected, Synthetic Biologics' ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics' ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' products by competitors that render Synthetic Biologics' products obsolete or non-competitive, Synthetic Biologics' ability to maintain its license agreements, the continued maintenance and growth of Synthetic Biologics' patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics' ability to establish and maintain collaborations, Synthetic Biologics' ability to obtain or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics' key scientists or management personnel, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2015 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. 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.