Soligenix Announces Issuance of US Patent for Topically Active Steroids to Treat Inflammatory Gastrointestinal Disorders Supports Use of SGX203 in Treatment of Pediatric Crohn's Disease, Augmenting existing Orphan Drug Designation

PRINCETON, N.J., Sept. 13, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the company), a development stage biopharmaceutical company announced today that the US Patent Office granted patent 8,263,582 entitled "Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids." The new patent's main claims cover the use of beclomethasone dipropionate (BDP) in orally administered dosage forms that act concurrently in both the upper and lower gastrointestinal tract. These dosage forms include the Company's oral formulation of BDP, a topically active corticosteroid, currently in development for pediatric Crohn's disease, acute radiation enteritis, and gastrointestinal Graft-versus-Host disease (GVHD).

"The granting of this patent marks a key addition to our intellectual property portfolio in the field of topically active steroids," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "It demonstrates the novelty and utility of our two-tablet system comprising an immediate release and a delayed release combination of oral BDP and underpins our approach to treating multiple inflammatory gastrointestinal disorders such as pediatric Crohn's disease."

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, BDP also benefits from several orphan drug designations in the US and abroad, including SGX203 for the treatment of pediatric Crohn's disease, which provides for seven years of post-approval market exclusivity in the US.

About Oral BDP
Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma.  Soligenix is currently developing oral formulations of BDP, including its proprietary two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.   

About Soligenix, Inc.
Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing proprietary formulations of oral BDP for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial.

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 NIH.

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. Statements that are not historical facts, such as "anticipates," "believes," "intends," 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 or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, 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 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, 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.



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