Soligenix Awarded BARDA Contract Valued up to $26.3 Million for Advanced Development of OrbeShield™ in GI ARS

   Soligenix Awarded BARDA Contract Valued up to $26.3 Million for Advanced
                     Development of OrbeShield™ in GI ARS

PR Newswire

PRINCETON, N.J., Sept. 19, 2013

PRINCETON, N.J., Sept. 19, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a clinical stage biopharmaceutical company focused
on developing products to treat inflammatory diseases and biodefense medical
countermeasures (MCMs) where there remains an unmet medical need, announced
today that it has been awarded a contract valued at up to $26.3 million by the
US Department of Health and Human Service's Biomedical Advanced Research and
Development Authority (BARDA). The contract is for the advanced preclinical
and manufacturing development of OrbeShield™ (oral beclomethasone
17,21-dipropionate or oral BDP) as a MCM for the treatment of gastrointestinal
acute radiation syndrome (GI ARS).

The potential five year contract contains a two year base period, with two
contract options that would extend the contract an additional three years. The
total award will support the preclinical and manufacturing development
activities necessary to successfully navigate and complete the FDA approval
process for use of OrbeShield™ to treat GI ARS.

"Securing a highly competitive BARDA contract provides important recognition
as to the innovative quality and potential therapeutic impact of our
technology," stated Christopher J. Schaber, PhD, President & Chief Executive
Officer of Soligenix. "This contract award provides the comprehensive funding
necessary to continue development of OrbeShield™ while building upon the
growing body of compelling scientific evidence supporting its use as a
potential MCM for GI ARS. We thank BARDA for their support and look forward
to collaborating closely with them as we advance this technology."

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems,
notably the bone marrow the GI tract and later the lungs. In the event of a
nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed
to >2 Gy are at high risk for development of clinically significant ARS.
Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury
which can result in death in 5-15 days. The GI tract is highly sensitive due
to the requirement for incessant proliferation of crypt stem cells and
production of mucosal epithelium. The extent of injury to the bone marrow and
the GI tract are the principal determinants of survival after exposure to
TBI. Although the hematopoietic syndrome can be rescued by bone marrow
transplantation or growth factor administration, there is no established
treatment or preventive measure for the GI damage that occurs after high-dose
radiation. Therefore, there is an urgent need to develop specific MCMs against
the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™

OrbeShield™ is formulated for oral administration in GI ARS patients as a
single product consisting of two tablets; one tablet releases BDP in the
proximal portions of the GI tract and the other tablet releases BDP in the
distal portions of the GI tract. BDP has been marketed in the US and
worldwide since the early 1970s as the active pharmaceutical ingredient in
inhalation products for the treatment of patients with allergic rhinitis and
asthma. To date, oral BDP has been safely administered to more than 350 human
subjects in multiple clinical studies. Oral BDP is also being developed in
other GI disorders characterized by severe inflammation such as pediatric
Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease
(cGVHD).

The FDA has cleared the Investigational New Drug (IND) application for
OrbeShield™ for the mitigation of morbidity and mortality associated with GI
ARS. OrbeShield™has also been granted Orphan Drug and Fast Track
designations by the FDA for the prevention of death following a potentially
lethal dose of total body irradiation during or after a radiation disaster.

About BARDA

The Biomedical Advanced Research and Development Authority within the Office
of the Assistant Secretary for Preparedness and Response in the US Department
of Health and Human Services, provides an integrated, systematic approach to
the development and procurement of critical products needed for public health
emergencies. In collaboration with the National Institutes of Health,
Department of Homeland Security, and other federal agencies, BARDA plays a key
role in the government's efforts to develop MCMs needed to prevent or mitigate
potential health effects from exposure to chemical, biological, radiological
and nuclear (CBRN) agents and other terrorist threats. Support for OrbeShield™
product development is being provided under a CBRN program to advance
technologies and products to treat acute radiation syndrome (ARS). Funding
for BARDA's MCM development programs is authorized under the Pandemic and All
Hazards Preparedness Act of 2006 (PAHPA) and reauthorized under the Pandemic
and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). Additional
MCM programs are funded by BARDA under the Project BioShield Act of 2004.

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to
treat serious inflammatory diseases where there remains an unmet medical need,
as well as developing several biodefense vaccines and therapeutics. Soligenix
is developing proprietary formulations of oral BDP (beclomethasone
17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders
characterized by severe inflammation, including pediatric Crohn's disease
(SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host
disease (orBec^®), as well as developing its novel innate defense regulator
(IDR) technology SGX942 for the treatment of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures
pursuant to the Biomedical Advanced Research and Development Authority (BARDA)
Strategic Plan of 2011-2016 for inclusion in the US government's Strategic
National Stockpile. Soligenix's lead biodefense products in development are a
recombinant subunit vaccine called RiVax™, which is designed to protect
against the lethal effects of exposure to ricin toxin and VeloThrax™, a
vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated
and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both
RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National
Institute of Allergy and Infectious Diseases (NIAID) grant supporting
development of Soligenix's new vaccine heat stabilization technology known as
ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of
gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID
Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously
demonstrated statistically significant preclinical survival results in two
separate canine GI ARS studies funded by the NIAID. Recently, Soligenix
announced a worldwide exclusive collaboration with Intrexon Corporation that
will focus on the joint development of a treatment for Melioidosis, a high
priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's
website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix,
Inc.'s current expectations about its future results, performance, prospects
and opportunities, including but not limited to, potential market sizes,
patient populations and clinical trial enrollment. Statements that are not
historical facts, such as "anticipates," "estimates," "believes," "intends,"
"potential," or similar expressions, are forward-looking statements. These
statements are subject to a number of risks, uncertainties and other factors
that could cause actual events or results in future periods to differ
materially from what is expressed in, or implied by, these statements.
Soligenix cannot assure you that it will be able to successfully develop,
achieve regulatory approval for or commercialize products based on its
technologies, particularly in light of the significant uncertainty inherent in
developing vaccines against bioterror threats conducting preclinical and
clinical trials of vaccines, obtaining regulatory approvals and manufacturing
vaccines, that product development and commercialization efforts will not be
reduced or discontinued due to difficulties or delays in clinical trials or
due to lack of progress or positive results from research and development
efforts, that it will be able to successfully obtain any further funding to
support product development and commercialization efforts, including grants
and awards, maintain its existing grants which are subject to performance,
enter into any biodefense procurement contracts with the US Government or
other countries, that it will be able to compete with larger and better
financed competitors in the biotechnology industry, that changes in health
care practice, third party reimbursement limitations and Federal and/or state
health care reform initiatives will not negatively affect its business, or
that the US Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. These and other risk
factors are described from time to time in filings with the Securities and
Exchange Commission, including, but not limited to, Soligenix's reports on
Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation
to update or revise any forward-looking statements as a result of new
information or future events.

SOURCE Soligenix, Inc.

Website: http://www.soligenix.com
Contact: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200,
www.soligenix.com
 
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