Soligenix completes US manufacturing transfer for synthetic hypericin active ingredient.

Soligenix, a biopharmaceutical company, has completed the transfer of the manufacturing process for its synthetic hypericin active ingredient from Europe to the US. The transfer includes the optimization and implementation of a commercially viable, scalable production process for the active ingredient used in HyBryte and SGX302, treatments for cutaneous T-cell lymphoma and psoriasis.

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases, has successfully completed the transfer of its synthetic hypericin active ingredient manufacturing process from Europe to the United States. The transfer, which includes the optimization and implementation of a commercially viable, scalable production process, is a significant milestone for the company.

The active ingredient, synthetic hypericin, is used in the topical drug product formulations HyBryte™ and SGX302, which are being developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively. Soligenix has partnered with Sterling Pharma Solutions to achieve this transfer, with the goal of establishing a long-term commercial manufacturing collaboration under current good manufacturing practice (cGMP) standards.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, stated, "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. 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."

Adam Kujath, Site Head at Sterling Pharma Solutions' Germantown, WI facility, added, "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."

The transfer of manufacturing to the U.S. is expected to enhance Soligenix's ability to meet the growing demand for its products and potentially reduce costs. The company has already demonstrated the potential of its topical hypericin treatment in clinical trials, with positive results in a Phase 3 study for CTCL.

References:
[1] https://www.streetinsider.com/PRNewswire/Soligenix+Announces+Synthetic+Hypericin+Successfully+Manufactured+at+Sterling+Pharma+Solutions/25001299.html