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Akebia Therapeutics Announces Amendment of License Agreement with Vifor Pharma in Preparation for Potential Vadadustat Launch
Agreement Leverages Vifor Pharma's Exclusive Distribution Arrangement with Certain Dialysis Organizations Agreement Defines Profit Share Economics of
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Agreement Leverages Vifor Pharma's Exclusive Distribution Arrangement with Certain Dialysis Organizations\n Agreement Defines Profit Share Economics of Potential Vadadustat Revenue if Approved\n - Vifor Pharma to make equity purchase of $20 million\n - $40 million refundable working capital investment to partially fund launch supply\n - $25 million upfront payment\n\n\nCAMBRIDGE, Mass., Feb. 22, 2022 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and Vifor Pharma Group (Vifor Pharma), today announced that the companies have amended and restated the terms of their license agreement, pursuant to which Akebia Therapeutics, Inc. (Akebia) granted Vifor Pharma an exclusive license to sell vadadustat, Akebia's investigational oral therapeutic for the treatment of anemia due to chronic kidney disease (CKD), to Fresenius Medical Care North America and its affiliates (including Fresenius Kidney Care Group LLC) and other entities in the United States, subject to vadadustat's approval by the U.S. Food and Drug Administration (FDA). Vadadustat's Prescription Drug User Fee Act (PDUFA) date is March 29, 2022. \n\n \n \n \n \n \n \n\n \nThe new agreement further supports Akebia's commercialization strategy ahead of a potential first-in-class U.S. launch for vadadustat which, as previously noted, provides access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships. Previous agreements between the companies granted Vifor Pharma an exclusive license to sell vadadustat, if approved by the FDA, to Fresenius Kidney Care Group for use solely within its dialysis facilities and certain other third-party dialysis facilities in the U.S. The new agreement further expands this license to also include additional independent dialysis organizations. \n\"Vifor Pharma shares our commitment to bring innovative treatments to people living with kidney disease, which has been a cornerstone of our longstanding relationship,\" said John P. Butler, Chief Executive Officer of Akebia. \"As we approach vadadustat's PDUFA date and potential launch, we are thrilled to clarify the agreement, which we believe will enable our companies to get vadadustat to dialysis patients more quickly.\" \nIn consideration for the extension of Vifor ...