Akebia Therapeutics Inc. (NASDAQ: AKBA) has announced the amendment and restated terms of its license agreement with Vifor Pharma Group. According to the amendment, Akebia has granted Vifor Pharma exclusive for commercialization of its experimental oral therapy, vadadustat, to treat chronic kidney disease caused by anemia, to Fresenius Medical Care North America its affiliates plus other entities in the U.S.
Agreement subject to FDA receiving FDA approval
The agreement is subject to vadadustat’s FDA approval by the FDA. The Prescription Drug User Fee Act date for vadadustat is March 29, 2022.
The new deal strengthens Akebia’s marketing strategy prior to a possible first-in-class U.S. debut for vadadustat, which, as stated previously, has access to around 60% of dialysis patients in the United States thanks to existing Vifor Pharma ties. Vifor Pharma previously had an exclusive license to commercialize vadadustat to Fresenius Kidney Care Group to be used exclusively within its dialysis institutions as well as certain third-party dialysis centers in the United States if the FDA authorized it. The new arrangement broadens the scope of the license to cover additional independent dialysis providers.
Akebia CEO John Butler said, “Vifor Pharma shares our commitment to bring innovative treatments to people living with kidney disease, which has been a cornerstone of our longstanding relationship. 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.”
Vifor commits to $20 million share purchase
In exchange for the expansion of Vifor Pharma’s customer base, the company agreed to a $20 million further share purchase. Vifor Pharma will also contribute $40 million in working capital to partially pay Akebia’s manufacturing costs for vadadustat in order to enable commercialization in the United States.
Vifor Pharma will pay Akebia the previously agreed amount of $25 million milestones under the modified and restated arrangement provisions. In addition, after deducting certain pre-specified charges, Akebia will keep around 66 percent of the profit.