ROCKVILLE, Md., July 12, 2016
/PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a
clinical stage company focused on developing therapeutics to
protect the gut microbiome announced today that the European Patent
Office has granted European Patent No. 2576776 which provides
composition of matter coverage for ribaxamase, the Company's Phase
2 drug candidate designed to degrade certain IV beta-lactam
antibiotics within the GI tract and maintain the natural balance of
the gut microbiome for the prevention of Clostridium
difficile infection (CDI), antibiotic-associated diarrhea (AAD)
and the emergence of antibiotic-resistant organisms. This is
Synthetic Biologics' first patent directly pertaining to ribaxamase
in Europe and adds to the
Company's established and extensive patent estate.
In addition, the U.S. Patent and Trademark Office (USPTO) has
granted US Patent No. 9,376,673, and issued a Notice of Allowance
for another application (US 15/160,669), with composition of matter
claims for various beta-lactamase candidates related to ribaxamase.
These new patent assets further strengthen the Company's coverage
of its novel proprietary candidate, ribaxamase, which is also
covered by a previously granted composition of matter patent in the
U.S.
"The successful granting of this composition of matter patent in
Europe, alongside our continued
patent successes in the U.S., further strengthens Synthetic
Biologics' role as a leader in the development of
microbiome-focused programs intended to address largely unmet
medical needs," said Jeffrey Riley,
President and Chief Executive Officer. "As we continue to enjoy
momentum in the clinic, our progress is further complimented by our
well established and reinforced patent estate for ribaxamase."
Ribaxamase is designed to degrade certain intravenous (IV)
beta-lactam antibiotics excreted into the gastrointestinal (GI)
tract to maintain the natural balance of the gut microbiome. C.
difficile is associated with approximately 453,000 CDIs and
> 29,000 C. difficile-related deaths in the United States each year[i]. Upon issuance,
these newly allowed applications reinforce Synthetic Biologics'
extensive C. difficile-related patent estate, which includes
approximately 40 U.S. and foreign patents and approximately 30 U.S.
and foreign patent pending applications, and patents and patent
applications with terms that extend from at least 2031 to 2036.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development are: (1) SYN-010 which is intended to reduce
the impact of methane producing organisms in the gut microbiome to
treat an underlying cause of irritable bowel syndrome with
constipation (IBS-C), and (2) ribaxamase which is designed to
protect the gut microbiome from the effects of certain commonly
used intravenous (IV) beta-lactam antibiotics for the prevention of
C. difficile infection, antibiotic-associated diarrhea (AAD)
and the emergence of antibiotic-resistant organisms. The Company is
also developing preclinical stage monoclonal antibody therapies for
the prevention and treatment of pertussis and novel discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). For
more information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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, and include statements
regarding the further strengthening of the patent estate,
the continued success in the U.S., the continued momentum in the
clinic and the intended benefit of SYN-010 and ribaxamase.
These forward-looking statements are based on
management's expectations and assumptions as of the date of this
press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could
cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any
forward-looking statements. Important factors that could cause
actual results to differ materially from current expectations
include, among others, Synthetic Biologics' product
candidates demonstrating safety and effectiveness, as well as
results that are consistent with prior results, Synthetic
Biologics' ability to initiate clinical trials and if initiated, to
complete them on time and achieve desired results and benefits,
Synthetic Biologics' clinical trials continuing enrollment as
expected, Synthetic Biologics' ability to obtain regulatory
approvals for commercialization of product candidates or to comply
with ongoing regulatory requirements, regulatory limitations
relating to Synthetic Biologics' ability to promote or
commercialize its product candidates for specific indications,
acceptance of its product candidates in the marketplace and the
successful development, marketing or sale of Synthetic Biologics'
products by competitors that render Synthetic Biologics'
products obsolete or non-competitive, Synthetic Biologics'
ability to maintain its license agreements, the continued
maintenance and growth of Synthetic Biologics' patent
estate, Synthetic Biologics becoming and remaining profitable,
Synthetic Biologics' ability to establish and maintain
collaborations, Synthetic Biologics' ability to obtain
or maintain the capital or grants necessary to fund its research
and development activities, a loss of any of Synthetic
Biologics' key scientists or management
personnel, and other factors described in Synthetic
Biologics' Annual Report on Form 10-K for the year ended
December 31, 2015 and its other
filings with the SEC, including subsequent periodic reports on
Forms 10-Q and 8-K. 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.
[i] Leffler DA et al. N Engl J Med 2015;
372:1539-1548.
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SOURCE Synthetic Biologics, Inc.