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Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe
Date:7/28/2011

mercialization partner in the second major world market and we are pleased with the robust royalty rates that we have garnered through this strong business relationship.  There will also be significant economies of scale that we will realize through having one partner in both major territories.  This partnership will provide for the launch and commercialization of orBec® in North America and Europe, without any further related expense to Soligenix or its shareholders.  It also provides us with the potential for ongoing development funding across multiple indications for orBec® and oral BDP."  

About orBec®

orBec®, oral beclomethasone dipropionate (oral BDP), is currently the subject of a confirmatory Phase 3 clinical trial in the treatment of acute GI GVHD. This Phase 3 trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec® Randomized Treatment Study), will enroll an estimated 166 patients to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value 0.005) in the Company's previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec® (i.e., 30 days following cessation of treatment). The SUPPORTS trial is being conducted at major transplant centers throughout the US, Europe, and Australia and is expected to complete in the second half of 2011.  The trial is the subject of a Special Protocol Assessment (SPA) agreement that the Company reached with the US Food and Drug Administration (FDA).

orBec® was the subject of two prior randomized, double-blind, placebo-controlled clinical trials in acute GI GVHD. The first study was a 60-patient Phase 2 single-cent
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