2014

Synthetic Biologics Responds to Recent CDC Report on Threat of "Super Bugs"

ROCKVILLE, Md., Sept. 20, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases, has issued a response to the recent report issued by the Centers for Disease Control and Prevention (CDC) earlier this week that detailed the growing threat of antibiotic-resistant "super bugs" (see here: Untreatable: Report by CDC details today's drug-resistant health threats).

(Logo: http://photos.prnewswire.com/prnh/20130522/MM19465LOGO )

Below is a statement from the Company:

"We applaud the CDC for taking the step forward in acknowledging the major public health crisis surrounding drug-resistant "super bugs." Among the CDC's top three, newly-ranked, drug-resistant bacteria, is Clostridium difficile (C. diff). C. diff is a deadly bacterium, with 94% of cases being associated with medical care settings. While treating an infection, IV antibiotics can wipe out the balance of a patient's microbiome, leaving them susceptible to life-threatening C. diff infections. If patients contract C. diff, they can spend an additional 4-7 days in the hospital1, costing the U.S. healthcare system in excess of $8 billion annually2. Of the 1.1 million patient's infected with C. diff in the hospital setting3, 30,000 die with a C. diff infection in the United States each year4.

Currently, there are no approved treatments designed to protect a patient's microbiome from the damaging effects of IV antibiotics, leaving patients highly exposed to what's been dubbed the "nightmare infection" in many hospitals. We view the recent ranking of drug-resistant superbugs by threat level as encouragement from the CDC that they are considering elevating the call for – and investing in – new preventative and treatment options to combat them."

About SYN-004 – Synthetic Biologics' C. diff Preventative Biologic Candidate

Synthetic Biologics' lead anti-infective biologic candidate, SYN-004, is a novel point-of-care oral enzyme prevention for C. diff, designed to be co-administered with certain IV beta-lactam antibiotics and to neutralize the antibiotics in the gastrointestinal tract, therefore protecting the balance of the microbiome. Roughly 14.4 million patients are administered "SYN-004 target" IV beta-lactam antibiotics annually3, representing an estimated target market for SYN-004 of 117.6 million beta-lactam doses purchased by U.S. hospitals3. While the final dosing regimen for SYN-004 is yet to be determined, the addressable market is extremely significant. Currently there are no approved treatments designed to protect the microbiome from the damaging effects of IV antibiotics. This worldwide opportunity could represent a potential multi-billion dollar market.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of biologics for the prevention and treatment of serious infectious diseases. The Company is developing an oral enzyme for the prevention of C. difficile infections, and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections. In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.

To download Synthetic Biologics' investor relations mobile device app, which allows users access to the Company's SEC documents, press releases and events, please click on the following links to download the IRapp on your iPhone and iPad or your Android mobile device.

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 intent of the CDC's statements. 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 of SYN-004 to be demonstrably safe and effective or successfully commercialized, the development of competitive products, a failure to initiate animal trials or clinical trials and if initiated a failure to initiate them when planned or achieve the desired results, a failure to obtain regulatory approval for SYN-004 or to comply with ongoing regulatory requirements 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.

1 (APIC) National Prevalence Study of Clostridium difficile in U.S. Healthcare Facilities. November 11, 2008. http://hospitalacquiredinfections.blogspot.com/2008/12/november-11-2008-association-for.html.
2 Agency for Healthcare Research and Quality. Healthcare and Cost Utilization Project. Statistical Brief #124. Clostridium difficile Infections (CDI) in Hospital Stays, 2009. January 2012. Available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf.
3 This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
4 U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. Available at http://www.ahrq.gov/news/nn/nn012512.htm. Accessed November 5, 2012.

SOURCE Synthetic Biologics, Inc.



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