ROCKVILLE, Md., Sept. 12, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing
novel anti-infective biologic and drug programs targeting specific
pathogens that cause serious infections and diseases, announced
today that the U.S. Food and Drug Administration (FDA) has granted
Orphan Drug designation to the Company's proprietary SYN-005
monoclonal antibody (mAb) combination for the treatment of
Pertussis, more commonly known as whooping cough. In the U.S.,
Orphan Drug Designation provides a variety of incentives, including
seven years of market exclusivity, should SYN-005 receive FDA
approval for the treatment of Pertussis.
"Achieving this milestone is an important step in building the
foundation for our Pertussis clinical program. The next anticipated
milestone for SYN-005 is to initiate cGMP manufacturing in the
second half of this year, followed by the filing of an IND in
mid-2015 to support the initiation of a Phase I clinical trial,"
stated Jeffrey Riley, Chief
Executive Officer of Synthetic Biologics. "We expect this to become
an important new treatment option for patients suffering from
Pertussis."
Synthetic Biologics is developing SYN-005 through its Exclusive
Channel Collaboration with Intrexon Corporation (NYSE: XON) and
academic researchers at The University of
Texas at Austin to target and neutralize the pertussis toxin
in order to reduce morbidity and mortality in infected infants.
Pertussis is a highly contagious disease caused by the bacteria
Bordetella pertussis (B. pertussis) with symptoms that may
include chronic coughing and subsequent breathing difficulties.
According to the World Health Organization, there
are approximately 50 million worldwide cases of whooping cough
each year, leading to an estimated 300,000 deaths, primarily among
young, unvaccinated infants.
The Orphan Drug designation is granted to development-stage
novel therapeutics that offer potential value in the treatment of
rare diseases and medical conditions that affect fewer than 200,000
patients in the US. Orphan Drug designation qualifies the sponsor
of the drug for various development incentives of the Orphan Drug
Act, including tax credits for qualified clinical testing. A
marketing application for a prescription drug product that has
received Orphan Drug designation is not subject to the Prescription
Drug User Fee Act (PDUFA) fees unless the application includes an
indication for other than the rare disease or condition for which
the therapeutic was designated.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company focused on the development of novel anti-infective biologic
and drug candidates targeting specific pathogens that cause serious
infections and diseases. The Company is developing an oral biologic
to protect the gastrointestinal microflora from the effects of IV
antibiotics for the prevention of Clostridium difficile (C.
difficile) infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS), 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 a subset 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
www.syntheticbiologics.com.
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 Synthetic Biologics'
next anticipated milestones for SYN-005 for initiation of cGMP
manufacturing in the second half of 2014 and the filing of an IND
in mid-2015, the expectation of SYN-005 becoming a new treatment
option for patients suffering from Pertussis and the market size.
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, the additional
clinical studies and results not meeting expectations, our
inability to obtain regulatory approval and other factors described
in Synthetic Biologics' report on Form 10-K for the year ended
December 31, 2013 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.
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SOURCE Synthetic Biologics, Inc.