Sigma-Tau, Soligenix expand partnership to develop and commercialize orBec in Europe

Soligenix, Inc. (Soligenix or the Company) (OTC BB: SNGX), a late-stage biopharmaceutical company, announces the expansion and amendment of its North American licensing partnership with Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) for the development and commercialization of orBec® (oral beclomethasone dipropionate or Oral BDP) into the European territory.

As part of the amended agreement, Sigma-Tau has made a $5 million upfront payment to Soligenix.  In addition, Sigma-Tau will make additional payments to Soligenix totaling $11 million, subject to the achievement of certain milestones.  The first milestone, a $2 million payment, will be made upon the successful completion of the confirmatory Phase 3 clinical trial of orBec® for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD). Sigma-Tau will also pay Soligenix a 40% royalty on net sales pursuant to which Soligenix will supply the drug product while maintaining worldwide manufacturing rights. All commercialization expense in the European territory, including launch activities, will be borne by Sigma-Tau.

Ugo DiFrancecso, Chief Executive Officer of the Sigma-Tau Group which is headquartered in Rome, Italy, commented, "We are pleased to expand our partnership with Soligenix around orBec®. We remain optimistic about a near-term approval in the European market and the opportunity to bring our considerable expertise in the distribution of rare disease medicines to ensure that all GI GVHD patients throughout Europe will be able to access this important medicine."

"We expect the expanded Sigma-Tau collaboration will help us realize the full potential of orBec® and oral BDP in the treatment of GI GVHD and other inflammatory GI diseases," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "We now have an experienced commercialization 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."