Date: 2014-09-09
Type of information: Production agreement
Compound: patiromer
Company: Relypsa (USA - CA) Patheon (USA - NC)
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Type agreement:
Action mechanism: Patiromer is a non-absorbed, potassium-binding polymer being developed for the treatment of hyperkalemia. Hyperkalemia is typically defined as a serum potassium, or potassium in the blood, level greater than 5.0 milliequivalents per liter (mEq/L). Patients with serum potassium greater than or equal to 5.5 mEq/L, which we define as moderate-to-severe hyperkalemia, were found in an independent study to have a 10-fold increase in their mortality rate within 24 hours. Causes and risk factors for hyperkalemia include reduced renal function, diabetes, extensive soft tissue injury, age, high dietary potassium intake and the use of medications such as renin-angiotensin-aldosterone system (“RAAS”) inhibitors. Hyperkalemia occurs most frequently in patients with chronic kidney disease (“CKD”) where the ability of the patient’s kidney to excrete potassium has been compromised.
Disease: hyperkalemia
Details: * On September 9, 2014, Relypsa announced that it has entered into a multi-year commercial manufacturing and supply agreement with Patheon, 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. 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. 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 (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.
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