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May 20, 2014
08:14 EDTRLYPRelypsa announces commercial manufacturing agreement with DSM Fine Chemicals
Relypsa announced that it has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. DSM Fine Chemicals is a business unit of the newly formed DPx Holding B.V. which also owns Patheon Pharma Services and Banner Life Sciences. In addition to DSM Fine Chemicals, the company also has an agreement with Lanxess Corporation for the supply of API. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company's clinical development program. Relypsa expects Lanxess will be the initial sole manufacturer named in its planned New Drug Application, or NDA. The company plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential U.S. approval of patiromer.
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November 21, 2014
12:02 EDTRLYPRelypsa says all endpoints met in Phase 3 Patiromer FOS program
Relypsa announced that results from the pivotal Phase 3 program of the company's lead product candidate, Patiromer for Oral Suspension, were published today in New England Journal of Medicine. The program was conducted under Special Protocol Assessment to evaluate the safety and efficacy of Patiromer FOS for the treatment of hyperkalemia in chronic kidney disease patients on renin-angiotensin-aldosterone system inhibitor therapy. All endpoints were met in the two-part Phase 3 program consisting of a treatment phase, which was designed to assess the ability of Patiromer FOS to correct hyperkalemia, and a placebo-controlled randomized maintenance phase designed to evaluate the effect of continued treatment with Patiromer FOS on potassium control and ability of patients to continue RAAS inhibitor therapy compared to placebo. In the treatment phase, among 237 evaluable patients receiving Patiromer FOS, the mean change in the serum potassium level was −1.01 mEq/L (P<0.001). At week 4, 76% of the patients were within the target potassium level. Subsequently, 107 patients were randomly assigned to Patiromer FOS or placebo for the maintenance phase.
November 17, 2014
08:18 EDTRLYPRelypsa reports all endpoints met in Patiromer FOS clinical trials
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