CDMO Patheon To Manufacture Novel Polymer For Relypsa
By Cyndi Root
Relypsa, Inc. announced in a press release that it has engaged Patheon, a contract development and manufacturing organization (CDMO), to produce patiromer, a novel polymer. The multi-year commercial manufacturing and supply agreement with Patheon is for the finished product manufacture of the agent to treat hyperkalemia. Relypsa plans to name Patheon as the manufacturer in its New Drug Application (NDA) to the Food and Drug Administration (FDA). Wilhelm Stahl, Ph.D., SVP of Pharmaceutical Operations at Relypsa, said, “Having multiple, well-respected and proven global pharmaceutical suppliers gives us confidence in meeting potential demand and providing a high quality product to patients."
Relypsa and Patheon Agreement
Relyspa completed Phase III trials for patiromer, in which the drug met its primary and secondary endpoints. The company owns global commercialization rights to the agent and Intellectual Property (IP) rights in the U.S. until 2030. The agreement with Patheon allows the company to move forward with its FDA application and commercialization plans. The two companies did not disclose the financial terms.
API Supplier
Previously, Relypsa contracted with Lanxess Corporation and DSM Fine Chemicals for active ingredient supply. Lanxess and DSM supplied the active pharmaceutical ingredient (API) to Relypsa for its clinical development program. Relypsa plans to name Lanxess as the API supplier in the NDA and to contract with DSM for additional API manufacturing if patiromer is approved.
Patiromer
Patiromer, also known as RLY5016 for Oral Suspension, is an oral potassium binder. Patiromer treats hyperkalemia, in which patients have abnormally elevated levels of potassium in the blood. In Phase I, II, and III trials of Chronic Kidney Disease (CKD) patients with hyperkalemia, the agent met its efficacy endpoints, and patients found it tolerable. Current treatments for CKD include RAAS inhibitors in an effort to delay the progression to end stage renal disease. However, RAAS inhibitors can worsen hyperkalemia, thereby limiting their use. Relypsa states that the agent may be indicated for heart failure patients as hyperkalemia also affects those patients.
About Patheon
Patheon is a DPx Holdings B.V. business unit. It employs over 6,000 people at 12 manufacturing facilities and 9 development centers in Europe and North America. The company focuses on solid and sterile dosage forms, high potency drugs, and controlled/sustained release therapeutics.