Synthetic Biologics Reports that Flupirtine Sublicensee, Meda AB, to Initiate Phase II Fibromyalgia Clinical Trial in U.S.

Synthetic Biologics Reports that Flupirtine Sublicensee, Meda AB, to Initiate
                 Phase II Fibromyalgia Clinical Trial in U.S.

PR Newswire

ROCKVILLE, Md., Feb. 22, 2013

ROCKVILLE, Md., Feb. 22, 2013 /PRNewswire/ --Synthetic Biologics, Inc. (NYSE
MKT: SYN), a developer of synthetic biologics and innovative medicines for
serious infections and diseases, announced today that its flupirtine
sublicensee, Meda AB (Meda), has received a green light from the Food and Drug
Administration (FDA) to conduct a Phase II proof of concept study for the
treatment of fibromyalgia as reported in Meda's 2012 year-end report. Meda has
announced that the randomized, double-blind, placebo and active-controlled
study of patients with fibromyalgia will be conducted at 25 clinics in the
U.S.

In May 2010, the Company entered into an agreement with Sweden-based Meda
granting exclusive sublicense to all of its patents and pending patents
covering the use of flupirtine for fibromyalgia in the U.S., Canada and Japan.
Meda assumed all future development costs for the commercialization of
flupirtine for fibromyalgia. Synthetic Biologics received an upfront payment
and is entitled to future milestone payments, plus royalties.

"We are pleased to share Meda's update on the status of its clinical
development program of flupirtine for fibromyalgia," stated Jeffrey Riley,
Chief Executive Officer at Synthetic Biologics. "We believe Meda's experience
with flupirtine outside of the U.S. will help bring this potential new class
of treatment to the millions of people that suffer from fibromyalgia in the
U.S."

About Fibromyalgia and Flupirtine

Fibromyalgia is a chronic and debilitating condition characterized by
widespread pain and stiffness throughout the body, accompanied by severe
fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 3-6% of
the population worldwide, including an estimated 10 million patients in the
U.S. There are presently three products approved for this indication in the
U.S. – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from
these products in that it employs a unique mode of action.

Flupirtine is a first-in-class, novel type of central nervous system agent
known as a selective neuronal potassium channel opener that also has NMDA
receptor antagonist properties. Flupirtine is currently approved and marketed
by Meda for the treatment of pain in various countries outside of the U.S.

About Synthetic Biologics, Inc.

Synthetic Biologics is a biotechnology company focused on the development of
product candidates for serious infections and diseases. Synthetic Biologics is
developing a biologic for the prevention of C. difficile infection, and a
series of monoclonal antibodies for the treatment of serious infectious
diseases, including pertussis and Acinetobacter. The Company is also
developing a synthetic DNA-based therapy for the treatment of pulmonary
arterial hypertension. In addition, the Company is developing a drug candidate
for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive
dysfunction in MS, is designing a clinical development pathway for the
treatment of amyotrophic lateral sclerosis and has partnered the development
of a fibromyalgia treatment to Meda AB. For more information, please visit
Synthetic Biologics' website at www.syntheticbiologics.com.

To download Synthetic Biologics' investor relations mobile device app, which
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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 Meda's prior experience with flupirtine and
its impact on U.S. regulatory approval. 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 achieve regulatory approval and other factors
described in Synthetic Biologics' report on Form 10-K/A for the year ended
December 31, 2011 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.

Website: http://www.syntheticbiologics.com
Contact: Kris Maly, Vice President, Corporate Communication, +1-734-332-7800,
ext. 22
 
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