Active Ingredient Manufacturing Transfer to the U.S. Complete
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has successfully completed the transfer of the manufacturing process for its synthetic hypericin active ingredient under its partnership agreement with Sterling Pharma Solutions (Sterling). The transfer from Europe to the United States (U.S.) included the optimization and implementation of a commercially viable, scalable production process for this important active ingredient, which is used in the topical drug product formulations HyBryte™ and SGX302 being developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions. Soligenix and Sterling have enabled cGMP (current good manufacturing practice) manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.
“We are pleased to have successfully produced larger quantities of cGMP synthetic hypericin, and look forward to continuing to work with Sterling to refine the process for process validation while further reducing our cost of goods,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We look forward to building on our already strong relationship to advance our topical hypericin clinical programs, most notably, HyBryte™ for the treatment of early-stage CTCL, toward potential commercialization worldwide.”
“Sterling is pleased to be collaborating with Soligenix on this important program. We believe that Sterling’s expertise in active pharmaceutical ingredient manufacturing, including developing innovative solutions such as continuous flow chemistry for this product, will continue to provide great value to the Soligenix program while we work towards a commercial supply agreement,” stated Adam Kujath, Site Head at Sterling Pharma Solutions’ Germantown, WI facility.
