Synthetic Biologics Announces Issuance of U.S. Patent Adding Another Layer of Protection for the Use of Oral Estriol Candidate, Trimesta™, for Multiple Sclerosis

ROCKVILLE, Md., March 10, 2014 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA). The patent includes claims to the use of the Company’s drug candidate, Trimesta (oral estriol), in conjunction with a gestagen for the treatment of multiple sclerosis (MS) and other autoimmune diseases. The patent also includes a claim for the administration of Trimesta, a gestagen and a third standard of care MS agent, such as glatiramer acetate injection (Copaxone®), interferon beta-1a (Avonex®, Rebif®), interferon beta-1b (Betaseron®, Extavia®) or sphingosine-1-phosphate receptor modulator (Gilenya®). Through its wholly owned subsidiary, Synthetic Biologics holds the exclusive license to the newly issued U.S. Patent 8,658,627, as well as U.S. Patents 8,372,826 and 6,936,599 and pending patents for MS and other autoimmune diseases covering the uses of its oral estriol candidate, Trimesta.

Synthetic Biologics, Inc. Logo

In an on-going randomized, double-blind, placebo-controlled Phase II clinical trial for the treatment of women with relapsing-remitting MS, patients enrolled at 15 centers in the U.S. are administered either Trimesta in combination with Copaxone® and progesterone (a gestagen), or receive a placebo plus Copaxone®. Lead Principal Investigator of the clinical trial, Rhonda Voskuhl, M.D., Professor, Department of Neurology, Jack H. Skirball Chair in Multiple Sclerosis Research and Director, Multiple Sclerosis Program at the UCLA School of Medicine, is scheduled to present topline results from this trial at the American Academy of Neurology’s (AAN) 66th Annual Meeting in Philadelphia on April 29 & 30, 2014, as part of the AAN Emerging Science program. The clinical trial is supported by grants exceeding $8 million, awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS’s Southern California chapter, and the National Institutes of Health.

“Claims in this new patent further expand Synthetic Biologics’ intellectual property related to our oral estriol candidate, Trimesta, for the treatment of MS and other autoimmune diseases,” stated Jeffrey Riley, Chief Executive Officer at Synthetic Biologics. “Our objective has been to continue to strengthen our intellectual property covering oral estriol and this patent is an achievement in that direction.”

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases. The Company is developing an oral treatment to reduce the impact of methane producing organisms on conditions such as constipation-predominant irritable bowel syndrome (C-IBS), an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of C. diff infection, a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of IBS. In addition, the Company is developing an oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at

Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Avonex® is a registered trademark of Biogen Idec.
Rebif® is a registered trademark of EMD Serono, Inc. or its affiliates.
Betaseron® is a registered trademark of Bayer HealthCare Pharmaceuticals.
Extavia® is a registered trademark of Novartis AG.
Gilenya® is a registered trademark of Novartis AG.

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 the expected benefits of U.S. Patent No. 8,658,627 to Synthetic Biologics. 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, the results of the on-going clinical trial for Trimesta and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2012 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.

SOURCE Synthetic Biologics, Inc.