Soligenix Partners with Sterling for Hypericin Production

On Oct 3, 2024

Soligenix, Inc., the Princeton-based late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, has established a partnership agreement with Sterling Pharma Solutions to optimize and implement a commercially viable, scalable production technology for synthetic hypericin.

Synthetic hypericin, the active ingredient in the topical drug product formulations HyBryte™ and SGX302 being developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively, is a potent photosensitizer that is topically applied to skin lesions. Soligenix and Sterling are currently working to transfer and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.

“We look forward to working with Sterling as we expand our synthetic hypericin manufacturing capabilities with the ultimate goals of scaling up the process 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 and testing will provide great value to the Soligenix program while we work towards a commercial supply agreement. We look forward to working with the Soligenix team to help advance this program through the upcoming HyBryte™ Phase 3 confirmatory clinical study,” stated Adam Kujath, site head at Sterling Pharma Solutions’ Germantown, MD facility.

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