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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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March 15, 2015
13:51 EDTRLYPRelypsa announces Phase 2 Data showing efficacy of Patiromer FOS in HF patients
Relypsa announced that one year data showing the safety and efficacy of Patiromer for Oral Suspension-Patiromer FOS, Relypsa's lead product candidate, in heart failure, HF, patients with hyperkalemia receiving ongoing treatment with renin-angiotensin-aldosterone system, RAAS, inhibitors will be presented today as a poster at the American College of Cardiology 64th Annual Scientific Session. The poster data is a sub-group analysis of a multi-center, randomized, open-label Phase 2 trial, AMETHYST-DN, led by Bertram Pitt, M.D., Professor of Medicine, Emeritus, University of Michigan School of Medicine. In addition, Relypsa is sponsoring an industry panel to review the latest data in the management of hyperkalemia, led by Ileana L. Piņa, MD, Professor of Medicine and Epidemiology & Population Health at Albert Einstein College of Medicine. The U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act, PDUFA, action date of October 21 for completion of the review of the New Drug Application, NDA, for Patiromer FOS.
March 12, 2015
11:50 EDTRLYPRelypsa shares defended at Wedbush

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