Relypsa, Patheon Sign Supply Pact

Relypsa, Inc., a biopharmaceutical company based in Redwood City, California, has entered into a multi-year commercial manufacturing and supply agreement with Patheon for the finished product manufacture of patiromer, a novel polymer in development for treating hyperkalemia, a condition defined as abnormally elevated levels of potassium in the blood. Patheon, the pharmaceutical services business unit of DPx Holdings B.V, is a provider of drug development and commercial manufacturing services.

Relypsa also has agreements with Lanxess Corporation and DSM Fine Chemicals (also part of DPx Holdings) for the supply of the active pharmaceutical ingredient of patiromer. Lanxess, DSM Fine Chemicals, and Patheon manufactured drug supplies that were used during clinical development program. Patheon and Lanxess are planned to be the initial manufacturers named in Relypsa’s new drug application (NDA) for patiromer. Relypsa plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional API manufacturer upon potential US approval of patiromer.

Patiromer is a high capacity non-absorbed, non-metal oral potassium binder and is Relypsa’s lead product. The company’s two-part Phase III trial of patiromer, for the treatment of hyperkalemia, has been completed, and the primary and secondary endpoints were met.

Source: Replysa

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