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Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant
Date:8/23/2010

of acute GI GVHD.  Through the award of this grant, the FDA clearly recognizes the need for treatment options in the unmet medical need of GVHD.  As a result, orBec® could become the first FDA-approved therapy to treat and prevent GVHD."

In addition to issued patents and pending worldwide patent applications, orBec® benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, as well as an orphan drug designation in the U.S. for the prevention of acute GVHD and the treatment of chronic GI GVHD.  Orphan drug designations provide for 7 and 10 years of market exclusivity upon approval in the U.S. and Europe, respectively. In the U.S., orphan drug designations also make the Company eligible for research funding provided by OOPD, in addition to receiving tax credits for certain research expenses and a waiver of expensive FDA application user fees.

About the FDA's Orphan Products Development Program

The goal of FDA's OPD Program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. The FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. The OPD grant awards are based on a review of how the proposed study will either help support product approval or provide essential data needed for product development. Applications are reviewed by panels of outside experts and are funded by priority score.

About Soligenix, Inc.

Soligenix, Inc. (Soligenix) is a late-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
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SOURCE Soligenix, Inc.
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