Full Press Release Details
Synthetic Biologics Initiates Manufacturing
of SYN-004 for Use in Preclinical and
Clinical Trials to Target the Prevention
of C. difficile Infections
-- Company's Proprietary Oral
Beta-Lactamase Enzyme Successful Evaluation Conducted by
FUJIFILM Diosynth Biotechnologies
MD, October 15, 2013 - Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases,
announced today the successful completion of the protein expression evaluation with regard to the Company's proprietary oral
beta-lactamase enzyme (SYN-004) targeting the prevention of Clostridium difficile (C. difficile or C. diff) infections,
America's most prevalent hospital-acquired bacterial infection.
FUJIFILM Diosynth Biotechnologies UK Limited
(Fujifilm) analyzed and demonstrated a greater than 20-fold improvement in SYN-004 expression titers with consistent biological
activity utilizing its pAVEway platform (an E. coli system) compared to the Bacillus platform previously employed
by Ipsat Therapeutics Oy (Finland) for the expression of P1A, a first-generation candidate of SYN-004. Pursuant to an agreement
entered into with Fujifilm on October 8th, manufacturing of SYN-004 material to support Synthetic Biologics' planned preclinical
and clinical studies is underway.
SYN-004, a novel second-generation oral
drug candidate in preclinical development for co-administration with commonly used IV antibiotics, is intended to prevent the development
of severe effects of C. diff infection, which is extremely harmful and potentially deadly. Designed to be given orally
to protect the gut flora (microbiome) while certain IV beta-lactam antibiotics (penicillins and cephalosporins) fight the primary
infection, SYN-004 is believed to have a similar profile to its first-generation predecessor, which demonstrated favorable protection
of the gut flora during treatment with certain penicillins,[1]
with the potential to act against a broader spectrum of IV beta-lactam antibiotics.
"We're very excited to be working
with the dedicated team at Fujifilm. With the SYN-004 production cell line evaluation and selection of the E. coli expression
clone successfully completed, we have initiated manufacturing of preclinical material for animal studies and cGMP production of
SYN-004 for clinical trials," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We are pleased
that these efforts move us closer toward our goal of developing a prophylactic to prevent the devastating effects of C. diff
infections, for which there is currently no other approved preventive therapy. We look forward to announcing the initiation of
preclinical studies during the first half of 2014, after which we plan to initiate our clinical trials."
Steve Bagshaw, Managing Director of Fujifilm
Diosynth Biotechnologies UK Limited said, "We are delighted that the pAVEway study performed in our R&D laboratories
has produced such a successful improvement in titers. We now look forward to performing further process optimization before scaling
up in our pilot scale laboratories and ultimately producing cGMP material to allow Synthetic Biologics to carry out clinical trials
in the fight to provide a drug to counteract the effects of C. difficile infections."
About Clostridium difficile (C. difficile,
The CDC recently identified C. diff
as an "urgent public health threat," particularly given its resistance to many drugs used to treat other infections.[2]
C. diff infects 1.1 million Americans each year,[3]
and 30,000 patients die with a C. diff infection annually.[4]
This opportunistic infection adds an estimated 4-7 extra hospitalization days per patient,[5]
and is associated with $8.2 billion in overall annual hospital costs.[6]
C. diff infection is strongly associated with the use of IV antibiotics, which are administered to more than 24 million
Americans annually.[7] When IV antibiotics are given to
prevent or treat an infection, they can create a harmful imbalance in the gastrointestinal (GI) tract by wiping out helpful "good"
bacteria, which can allow C. diff to quickly grow out of control causing severe diarrhea, damaging the colon and in some
cases, leading to death.[8]
About Fujifilm Diosynth Biotechnologies (http://www.fujifilmdiosynth.com)
FUJIFILM Diosynth Biotechnologies UK Limited
is an industry leading biologics Contract Development and Manufacturing Organization. Fujifilm Diosynth Biotechnologies has extensive
experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules
expressed in a wide array of microbial, mammalian, and insect systems. The company offers a comprehensive list of services from
microbial and mammalian cell line development, including its proprietary pAVEway system, to process development, analytical
development, clinical and commercial manufacturing. Fujifilm Diosynth Biotechnologies is also located in Research Triangle Park,
NC, USA as FUJIFILM Diosynth Biotechnologies U.S.A., Inc. Both sites have been FDA-approved for the production of commercial biologic
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 our intention to develop and
commercialize a proprietary oral beta-lactamase enzyme product candidate to prevent C. difficile infections, our intention to commence
clinical trials and the expected size of the market for C. diff therapeutics. 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, Synthetic Biologics' inability to timely manufacture cGMP material or commence or
complete the clinical trials consistent with its current expectations and Synthetic Biologics' inability to successfully
develop, receive regulatory approvals for or to commercialize a new product candidate to prevent C. diff infection 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.
For further information, please contact:
Vice President, Corporate Communication
(734) 332-7800, ext. 22
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