ROCKVILLE, Md., April 4, 2013 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics
and innovative medicines for serious infections and diseases,
announced today that the U.S. Patent & Trademark Office has
issued U.S. Patent No. 8,372,826 entitled, Estriol Therapy for
Multiple Sclerosis and Other Autoimmune Diseases, to the
Regents of the University of California
which includes claims to the use of the Company's drug candidate,
Trimesta™ (oral estriol), in combination with
glatiramer acetate injection (Copaxone®). Copaxone® is the number
one selling drug for multiple sclerosis with approximately
$4 billion in annual sales. Currently
marketed exclusively by Teva Pharmaceutical Industries Ltd.,
Copaxone® is expected to face generic competition as certain patent
terms begin to expire in 2014.[1] Through its wholly owned
subsidiary, Synthetic Biologics holds the exclusive worldwide
license to U.S. Patent 8,372,826 and 6,936,599 and pending patents
for multiple sclerosis and other autoimmune diseases covering the
uses of its drug candidate, Trimesta™.
Trimesta™ is currently being utilized in
combination with Copaxone® in a randomized, double-blind,
placebo-controlled Phase II clinical trial for the treatment of
relapsing-remitting multiple sclerosis in women. Lead Principal
investigator, Rhonda Voskuhl, M.D.,
Director, University of California, Los
Angeles (UCLA) Multiple
Sclerosis Program, UCLA Department of Neurology, along with
investigators at 14 other centers in the U.S., are administering
either Trimesta™ (8 milligrams orally per day) in
combination with Copaxone® (20 milligrams per day), or a placebo
plus Copaxone® to patients enrolled in the trial.
"The claims in this new patent further expand Synthetic
Biologics' coverage of our proprietary oral estriol product
candidate, Trimesta™, to include its use in
combination with the leading FDA-approved multiple sclerosis drug,
Copaxone®," stated Jeffrey Riley,
Chief Executive Officer at Synthetic Biologics. "We look forward to
reporting the clinical results of this combination therapy after
the relapsing-remitting multiple sclerosis patients complete their
two years of dosing and monitoring scheduled for January 2014."
The 164-patient relapsing-remitting multiple sclerosis trial is
fully enrolled and it is anticipated that the last patient will
complete their last visit during January
2014. The primary outcome measure for the study is the rate
of relapse between the placebo and treated groups at two years, an
accepted FDA-approvable endpoint in MS. The clinical trial is
supported by grants exceeding $8
million, awarded by the National Multiple Sclerosis Society
in partnership with the National Multiple Sclerosis Society's
(NMSS) Southern California
chapter, and the National Institutes of Health.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) 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. For more information, please visit Synthetic
Biologics' website at www.syntheticbiologics.com.
To download Synthetic Biologics' investor relations mobile
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mobile device.
Copaxone® is a registered trademark of Teva Pharmaceutical
Industries Ltd.
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 timing of
completion of the trial. 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 of patients to successfully complete the trial
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.
[1] Teva Pharmaceutical Industries Ltd. Form 20-F filed with the
SEC for the year ended December 31,
2012.
SOURCE Synthetic Biologics, Inc.