Relypsa selects Patheon for finished dose manufacturing of patiromer

14-Sep-2014 - Last updated on 18-Dec-2023 at 15:08 GMT

Relypsa has entered into a multi-year commercial manufacturing and supply agreement with CMO Patheon for the finished product manufacture of patiromer, Relypsa's potential treatment of hyperkalemia.

Sylvia Wheeler, VP of Relypsa, told us that the contract with Patheon will last five years. “DSM Fine Chemicals will provide drug substance manufacturing services and Patheon will manufacture the finished drug product,” she said.

Relypsa also secured CMO Lanxess to manufacture and supply API and the company plans to file its NDA (New Drug Application) for the drug by Q3 of this year.

This is one of the first contracts that Patheon has won since merging with DSM in a $2.65bn deal.

"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, SVP of 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."

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 NDA. Relypsa also plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional API manufacturer upon potential U.S. approval of patiromer.

The contract for Patheon comes as the company recently acquired Gallus BioPharmaceuticals, which added two biologics plants to the company’s arsenal.