DSM Fine Chemicals is a business unit of the newly formed DPx Holding which also owns Patheon Pharma Services and Banner Life Sciences.
Relypsa senior vice president of pharmaceutical operations Wilhelm Stahl said the company is pleased to add DSM Fine Chemicals, a well-established contract manufacturer with significant experience in efficiently manufacturing polymers for therapeutic use, as a supplier of API for patiromer.
"Engaging another supplier is an important milestone towards preparing to cover our projected commercial demand and improving our security of supplies," Stahl said.
Apart from DSM Fine Chemicals, Relypsa also has an agreement with Lanxess, a contract manufacturer, for the supply of API.
Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during Relypsa’s clinical development program.
The company expects Lanxess will be the initial sole manufacturer named in its planned new drug application (NDA).
Relypsa intends to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential US approval of patiromer.
Patiromer is a high capacity non-absorbed, non-metal oral potassium binder currently under development for the treatment of hyperkalemia.
It was evaluated in CKD patients with hyperkalemia, including a two part Phase III trial, a 12-month Phase II trial and a 48-hour short-term Phase I onset-of-action trial.