Relypsa Enters Into Manufacturing Deal With DSM Fine Chemicals

Relypsa Inc. has announced that it has entered into a manufacturing contract with DSM Fine Chemicals. The multi-year commercial manufacturing and supply contract will be for the production of the active pharmaceutical ingredient, or API, of patiromer, which will be used in the development of hyperkalemia treatment.

Hyperkalemia refers to elevated potassium levels in the blood. The condition is potentially fatal, and those suffering from the condition also have other diseases or illnesses. Hyperkalemia is common in patients who are suffering from hypertension, kidney disease, heart failure, or diabetes.

Wilhelm Stahl, PhD and senior vice president of pharmaceutical operations at Relypsa, spoke about the agreement. “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,” he said. “Engaging another supplier is an important milestone towards preparing to cover our projected commercial demand and improving our security of supplies.”

Patiromer is a high capacity non-absorbed, non-metal oral potassium binder, which is used to treat patients suffering from hyperkalemia. The compound has been tested in a two part Phase 3 trial, a 12 month Phase 2 trial, and a 48 hour short term Phase 1 onset-of-action trial, and has seen success each time that it was tested by researchers. Patiromer met its efficacy endpoints  and was well tolerated in patients.

Relypsa has also entered into an agreement with Lanxess to supply API. Lanxess and DSM were both responsible for providing API to Relypsa during its clinical development program. Relypsa intends to name Lanxess the initial sole manufacturer in its planned New Drug Application (NDA). Once patiromer is approved in the U.S., the company plans to submit an NDA seeking approval to add DSM as an additional manufacturer.

DSM Fine Chemicals is a business unit of DPx Holding B.V., a company which also owns Banner Life Science and Patheon Pharma Services. DPx Holding has more than 20 different facilities around the world, including facilities in North America, Europe, Australia, and Latin America. The company is headquartered in Durham, North Carolina.