Relypsa Chooses Patheon As Supply Partner For Patiromer

Biopharmaceutical firm Relypsa announced that it has entered into a multi-year agreement with Patheon for the finished product manufacture and supply of patiromer.

Patiromer (RLY5016 for Oral Suspension) is a high capacity, non-absorbed, non-metal oral potassium binder being developed by Relypsa for the treatment of hyperkalemia. The compound is under investigation in a two-part Phase III study in chronic kidney disease (CKD) patients with hyperkalemia. The drug met its efficacy endpoint and demonstrated tolerability in both trials. In May, Relypsa announced top-line results for patiromer in the Phase I onset-of-action, where it has rapidly lowered potassium in patients within hours of initial dose administration.

Hyperkalemia is a serious condition characterized by abnormally high levels of potassium in the blood. The condition is frequently observed in patients with hypertension, diabetes, chronic kidney disease, and/or heart failure. Hyperkalemia can result in fatal cardiac arrhythmia and sudden death.

During the clinical development of patiromer, Patheon, along with Lanxess and DSM Fine Chemicals, produced drug supplies for Relypsa. Patheon is a pharmaceutical services business unit under DPx Holdings, a development and commercial manufacturing services company for prescription drugs.

Dr. Wilhelm Stahl, SVP of Pharmaceutical Operations at Relypsa, said, “With this Patheon agreement completed as well as our contracts with Lanxess Corporation and DSM Fine Chemicals, we have now solidified the commercial manufacturing commitments for patiromer active pharmaceutical ingredient and finished product that we believe can support our projected launch and commercialization of patiromer.” Dr. Stahl said that its recent forged partnerships will help it meet potential demand for patiromer. 

Relypsa said that it is eyeing both Patheon and Lanxess as the initial manufacturers for patiromer in its New Drug Application (NDA). The company said it plans to file with the U.S. Food and Drug Administration (FDA) in the third quarter of 2014. Relypsa is also currently preparing to file an NDA supplement for DSM Fine Chemicals as another API manufacturer for patiromer once it has received FDA approval.