Vifor Pharma Group has obtained exclusive rights to sell vadadustat to Fresenius Medical Care North America dialysis clinics upon approval by the U.S. Food and Drug Administration.
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently being developed by Akebia Therapeutics Inc. to treat anemia related to chronic kidney disease. The drug is currently undergoing phase three trials. The agreement will make vadadustat the HIF of choice for FMCNA dialysis patients.
Vifor Pharma will make a $50 million equity investment in Akebia at $14 per share.
The agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma and is subject to the drug’s FDA approval and inclusion in the bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Akebia’s revenue from the profit share and the milestone payment will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia’s U.S. collaborator.
If vadadustat is not included in the bundle, the Vifor rights will not apply and Otsuka will distribute to the entire U.S. market.
This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch,” said John P. Butler, President and Chief Executive Officer of Akebia. “We believe that this commitment provides significant further validation of vadadustat’s potential.”
Akebia and Otsuka plans to commercialize vadadustat in other dialysis organizations and centers and in the non-dialysis market in the U.S.