ProKidney to acquire manufacturing facility in North Carolina for REACT commercial production
ProKidney, a late clinical-stage cellular therapeutics company, has announced plans to acquire a 210,000 square foot facility and approximately 22 acres of land in Greensboro, North Carolina.
The move is aimed at meeting the company’s future commercial manufacturing needs for REACT, a renal autologous cell therapy currently in Phase 3 development for treating diabetic chronic kidney disease (CKD).
The transaction, valued at roughly $25.5 million, is set to close by June 2023, given standard closing conditions are met. Further investments are planned in the facility until 2028 in anticipation of potential commercial-scale production.
In alignment with the purchase agreement, ProKidney has been granted an incentive package approved by the city of Greensboro, Guilford County, and the North Carolina State Economic Investment Committee.
The company is eligible to receive up to $13.3 million in tax credits, contingent on the fulfilment of specific milestones. These include creating at least 330 new jobs by the end of December 2028, and an investment of approximately $458 million in real and personal property by the end of December 2027.
Dr Tim Bertram — ProKidney CEO said: “This purchase represents an important component of our strategic manufacturing buildout.
“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.”
Anticipating approval, a subsequent commercial launch in the US by the company is expected later in the same year. With these timelines as a guide, ProKidney is gearing up its infrastructure to potentially transition into a commercial entity, said Dr Tim Bertram.