ROCKVILLE, Md., July 18, 2013 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused
on the prevention and treatment of serious infectious diseases,
announced today the initiation of the manufacturing process of the
Company's proprietary beta-lactamase enzyme (SYN-004) to target the
prevention of Clostridium difficile (C. difficile or C.
diff) infections. Pursuant to an agreement with FUJIFILM
Diosynth Biotechnologies UK Limited (Fujifilm), the initial phase
of the SYN-004 manufacturing process is underway with the
evaluation of beta-lactamase protein expression in Fujifilm's
pAVEway™ platform. SYN-004 will be evaluated for production cell
line yields as well as biological activity of the enzyme
product.
"Initiating this expression platform evaluation with Fujifilm is
an important first step in the SYN-004 manufacturing process. These
efforts move us toward our goal of developing a prophylactic to
prevent the devastating effects of C. diff infections, for
which there is currently no vaccine or other approved preventive
therapy," stated Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics. "Upon completion of
production cell line evaluation and selection of the optimal
expression clone, we intend to proceed rapidly with manufacturing
of preclinical material for animal studies, and cGMP production of
SYN-004 for clinical studies."
Steve Bagshaw, Managing Director
of Fujifilm Diosynth Biotechnologies UK Limited said, "We are
excited to have the opportunity to demonstrate to Synthetic
Biologics the versatility of our pAVEway™ expression system for
SYN-004 production."
SYN-004: Targeting the Prevention of C. difficile
Infections
In November 2012, Synthetic
Biologics, Inc. acquired a series of oral beta-lactamase enzymes
(P1A, P2A and P3A) and related assets targeting the prevention of
C. difficile infections (CDI), the leading cause of hospital
acquired infections (HAI), that generally occur secondary to
treatment with intravenous antibiotics. The acquired assets include
a pre-Investigational New Drug (IND) package for SYN-004, a
2nd generation oral enzyme candidate (formerly known as
Ipsat Therapeutics P3A); Phase I and Phase II clinical data for P1A
(a 1st generation oral enzyme candidate); manufacturing
processes and data; and, a portfolio of issued and pending U.S. and
international patents intended to support an IND and Biologic
License Application (BLA) with the U.S. Food and Drug
Administration.
Utilizing this portfolio of assets, the Company intends to
develop a proprietary oral beta-lactamase enzyme product candidate,
SYN-004. When co-administered with certain intravenous beta-lactam
antibiotics, it is expected that SYN-004 can degrade the antibiotic
that is excreted in the gastrointestinal (GI) tract, thus
preserving the natural balance of the patient's microflora, and
preventing opportunistic infections including CDI. Beta-lactam
antibiotics are a mainstay in hospital infection management and
include the commonly used penicillin and cephalosporin classes of
antibiotics. In 2012, 15 million Americans were administered
beta-lactam antibiotics.*
Compared to the 1st generation oral enzyme candidate,
P1A, the Company believes that SYN-004 will be able to degrade a
broader spectrum of beta-lactam antibiotics, including both
penicillins and cephalosporins. Due to the structural similarities
between P1A and SYN-004 for the prevention of CDI, along with
previous discussions with the FDA, it is anticipated that certain
preclinical data collected on P1A may be used in support of an IND
for the Company's new product candidate, SYN-004.
About Clostridium difficile (C. difficile)
Infections
According to the Agency for Healthcare Research and Quality,
aggregate costs associated with CDI-related stays in the hospital
were $8.2 billion in the U.S. during
2009. CDI is a rising global HAI problem in which the toxins
produced by C. difficile bacteria result in diarrhea (C.
difficile-associated diarrhea (CDAD)), and in the most serious
cases, pseudomembranous colitis (erosion of the lower GI tract)
that can lead to death. CDI is a major, unintended risk associated
with the prophylactic or therapeutic use of intravenous
antibiotics, which may alter the natural balance of microflora that
normally protect the GI tract, leading to C. difficile
overgrowth and infection. Other risk factors for CDI include
hospitalization, prolonged length of stay, underlying illness,
immune-compromising conditions including the administration of
chemotherapy, and advanced age.
CDI is a widespread and often drug resistant infectious disease,
and it is estimated that 1.1 million patients are infected with
C. diff annually in the U.S.* Controlling the spread of CDI
has proven challenging, as the C. difficile spores are
easily transferred to patients via normal contact with healthcare
personnel and other inanimate objects. There is currently no
vaccine or approved product for the prevention of C. diff
infection.
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 products.
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.
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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 our intention to
develop and commercialize a proprietary oral beta-lactamase enzyme
product candidate using the acquired assets that will have the
desired results, 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, our inability to timely commence or complete
the clinical trials consistent with our current expectations and
our 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.
*This information is an estimate derived from the use of
information under license from the following IMS Health
Incorporated information service: CDM Hospital database for full
year 2012. IMS expressly reserves all rights, including rights of
copying, distribution and republication.
SOURCE Synthetic Biologics, Inc.