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.
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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.