Breaking News

ProKidney Purchases Manufacturing Facility in North Carolina

Will support future commercial manufacturing needs for Renal Autologous Cell Therapy.

ProKidney Corp., a late clinical-stage cellular therapeutics company focused on preserving kidney function in patients suffering from chronic kidney disease (CKD), entered into an agreement to purchase a 210,000 square-foot facility and approximately 22 acres of land in Greensboro, N.C.

The move is designed to support the company’s future commercial manufacturing needs for REACT, its Renal Autologous Cell Therapy, currently in Phase 3 development for the treatment of diabetic CKD.

Under the purchase agreement, ProKidney will pay approximately $25.5 million in cash for the facility and property. The transaction is expected to close by the end of June 2023.

In addition, the company plans to make investments in the facility through 2028 to prepare for potential commercial-scale manufacturing.

“This purchase represents an important component of our strategic manufacturing buildout,” said Tim Bertram, CEO of ProKidney. “With a staged investment strategy based on the clinical trial success of REACT, potential regulatory approval, and ultimately commercial demand, if approved, we intend, along with our current Winston-Salem facility, to supply enough REACT to match initial commercial demand. Subject to the outcome of the proact 1 and proact 2 clinical trials, we are targeting a Biological Licensing Agreement submission for Food and Drug Administration approval of REACT in 2026. Approval is projected to be followed by a possible commercial launch in the U.S. later that year. With these timelines in mind, we are developing our infrastructure in preparation for ProKidney’s potential shift to a commercial organization.”

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters