Sigma-Tau Pharmaceuticals is paying $5 million for European development and commercialization rights for Soligenix’ treatment of acute gastrointestinal graft-versus-host disease (GI GvHD), orBec®. Soligenix could receive another $11 million if it meets certain milestones along the development of this Phase III-stage candidate.
The first milestone, a $2 million payment, will be made upon the successful completion of the confirmatory late-stage trial. 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.
The Phase III trial for orBec, oral beclomethasone dipropionate (oral BDP), in acute GI GvHD will enroll an estimated 166 patients. The primary endpoint is the treatment failure rate at study day 80. The study is being conducted at transplant centers in the U.S., Europe, and Australia. OrBec is also in clinical development for the prevention of acute GvHD (Phase II) and treatment of chronic GvHD (Phase I).
Today's agreement builds on the companies’ existing arrangement, which spans North America. "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," states Christopher J. Schaber, Ph.D., 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,” Dr. Schaber adds. “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."