Relypsa, Inc. has announced that it has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient ("API") for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. DSM Fine Chemicals is a business unit of the newly formed DPx Holding B.V. which also owns Patheon Pharma Services and Banner Life Sciences.
"We are very 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," said Wilhelm Stahl, Ph.D., senior vice president pharmaceutical operations at Relypsa. "Engaging another supplier is an important milestone towards preparing to cover our projected commercial demand and improving our security of supplies."
In addition to DSM Fine Chemicals, the company also has an agreement with Lanxess Corporation, also a well-respected contract manufacturer, for the supply of API. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company's clinical development program.
Relypsa expects Lanxess will be the initial sole manufacturer named in its planned New Drug Application, or NDA. The company plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential U.S. approval of patiromer.