Relypsa, Inc., has entered into a multi-year commercial manufacturing and supply agreement with Patheon, Inc. for finished product manufacture of patiromer, Relypsa's novel polymer in development for the treatment of hyperkalemia. Patheon, the pharmaceutical services business unit of DPx Holdings B.V., is a global provider of development and commercial manufacturing services for prescription drugs.
"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," said Wilhelm Stahl, Ph.D., senior vice president Pharmaceutical Operations at Relypsa. "Having multiple, well-respected and proven global pharmaceutical suppliers gives us confidence in meeting potential demand and providing a high quality product to patients."
In addition to Patheon for finished product, Relypsa also has agreements with Lanxess Corporation and DSM Fine Chemicals (supplier of DPx Holdings' API business) for the supply of active pharmaceutical ingredient, or API. Lanxess, DSM Fine Chemicals and Patheon manufactured drug supplies that were used during Relypsa's clinical development program. Patheon and Lanxess are planned to be the initial manufacturers named in Relypsa's planned New Drug Application, or NDA. Currently, Relypsa plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional API manufacturer upon potential U.S. approval of patiromer.