ROCKVILLE, Md., Oct. 22, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing
novel pathogen-specific therapies for serious infections and
diseases, announced today that the U.S. Patent and Trademark Office
has issued a Notice of Allowance for a composition of matter patent
application that covers the lead product in its C.
difficile program, SYN-004. This is Synthetic Biologics' first
allowed patent application directly pertaining to SYN-004 in the
U.S. and adds to the Company's extensive C. difficile patent
estate.
SYN-004 is Synthetic Biologics' novel oral enzyme drug candidate
designed as the first and only prophylactic treatment intended to
prevent the development of C. difficile infections, by
binding with and neutralizing certain intravenous (IV) beta-lactam
antibiotics in the gut. SYN-004 is intended to block the effects of
antibiotics within the gastrointestinal (GI) tract, maintaining the
natural balance of bacterial flora (the gut microbiome),
potentially preventing the 1.1 million C. difficile
infections in the U.S. each yeari. The U.S. patent to be
issued has claims to compositions of matter and pharmaceutical
compositions of beta-lactamases, including SYN-004, and carries a
patent term to at least 2031. In addition to the newly allowed
patent, the Company has numerous related granted and pending U.S.
and international patent applications that are central to the
Synthetic Biologics' intellectual property estate.
"This new patent will strengthen the protection of Synthetic
Biologics' SYN-004 and reiterates our position as a key player in
the prevention of microbiome-based diseases," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "We continue to bolster the Company's patent
estate while making progress towards our goals to initiate Phase Ia
and Ib C. difficile clinical trials this quarter."
About C. difficile Infections
C. difficile is classified by the U.S. Centers for
Disease Control and Prevention (CDC) as an "urgent public health
threat," given its high prevalence and resistance to many drugs
used to treat other infections. It affects 1.1 million Americans
and causes 30,000 deaths each year,ii,iii adding an
estimated four to seven hospitalization days per
patientiv and $8.2 billion
in overall annual hospital costs.v C. difficile
infections are strongly associated with the use of IV antibiotics,
which are administered to more than 24 million Americans annually
to prevent or treat infections.vi These powerful
antibiotics can create a harmful imbalance in the GI tract by
wiping out helpful, "good" bacteria, and allowing C.
difficile to grow out-of-control, leading to severe diarrhea,
damaging the colon, and in some cases, death.vii
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company developing novel pathogen-specific therapies for 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 the continued
bolstering or the patent estate, the goals of initiating Phase Ia
and Ib C. difficile clinical trial this quarter, 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, our failure
to initiate trials within the anticipated time
frame, 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.
i
|
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.
|
ii
|
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.
|
iii
|
U.S. Department of
Health & Human Services. Agency for Healthcare Research and
Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm
Accessed: September 30, 2013.
|
iv
|
(APIC) National
Prevalence Study of Clostridium difficile in U.S. Healthcare
Facilities. November 11,
2008.http://hospitalacquiredinfections.blogspot.com/2008/12/november-11-2008-association-for.html
Accessed: September 30, 2013.
|
v
|
Agency for Healthcare
Research and Quality. Healthcare and Cost Utilization Project.
Statistical Brief #125. Clostridium difficile Infections (CDI) in
Hospital Stays, 2009. January 2012.
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf Accessed:
October 1, 2013.
|
vi
|
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.
|
vii
|
Committee to Reduce
Infection Deaths Web site
http://www.hospitalinfection.org/preventing_cdiff.shtml Accessed:
September 30, 2013.
|
Logo -
http://photos.prnewswire.com/prnh/20130522/MM19465LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/synthetic-biologics-announces-allowance-of-key-us-composition-of-matter-patent-for-c-difficile-program-275902307.html
SOURCE Synthetic Biologics, Inc.