Enzyvant Announces Plans to Expand Regenerative Medicine Manufacturing Capabilities

Enzyvant recently announced plans to develop a Good Manufacturing Practice (GMP)-compliant regenerative medicine manufacturing facility in Morrisville, NC, part of the Research Triangle Park area.

“Enzyvant is committed to ensuring scalable GMP manufacturing for RETHYMIC (allogeneic processed thymus tissue-agdc), and we’re looking ahead to potential needs in other indications and in support of other advanced regenerative medicine technologies,” said Enzyvant CEO William Symonds. “This new facility, once completed, will give us the size, flexibility, and nimble processing capability to serve both commercial and research needs.”

The development of the 25,972-sq-ft facility is expected to begin this summer and take approximately 2.5 years to complete once construction begins. Enzyvant currently has research and development offices in Durham, NC.

“I am very pleased about the novel capabilities this new manufacturing facility will bring to Enzyvant and look forward to the progress ahead as we look to realize efforts,” said Myrtle Potter, CEO of Sumitovant. “This is a great example of three members of the Sumitomo Pharma family of companies working seamlessly together to address the most pressing issues affecting patients and families with the highest unmet medical needs.”

The new manufacturing facility is being co-developed by and operated with Sumitomo Pharma, which owns Enzyvant’s immediate parent company, Sumitovant Biopharma.

“We’re excited that this new site not only expands the range and scope of our manufacturing offerings, but also builds our presence in Research Triangle Park – leveraging our existing employee base and support the local area with new hires,” said Larry Weiner, VP of Pharmaceutical Development & Manufacturing at Enzyvant.

Enzyvant is a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases. The company’s first commercial product is US FDA-approved RETHYMIC (allogeneic processed thymus tissue-agdc), a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. Enzyvant has distinctive capabilities in expedited development of regenerative therapies for rare diseases. The company has obtained and leveraged multiple regulatory designations including Regenerative Medicine Advanced Therapy, Breakthrough, Fast Track, Rare Pediatric Disease, Orphan Drug, and Advanced Therapies Medicinal Product. Enzyvant is wholly owned by Sumitovant Biopharma Ltd. (wholly owned by Sumitomo Pharma). For more information, visit Enzyvant.com.

Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant, a wholly-owned subsidiary of Sumitomo Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, visit www.sumitovant.com.