Vifor Pharma Group and Akebia Therapeutics announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the United States upon approval by the U.S. Food and Drug Administration (FDA).
Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia associated with chronic kidney disease (CKD).
“Vadadustat could represent a significant advancement in the treatment of renal anemia with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease. We believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents,” stated Stefan Schulze, President of the Executive Committee and Chief Operating Officer of Vifor Pharma. “This transaction strengthens the nephrology product portfolio of Vifor Pharma and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease.”
Under the terms of the agreement, Vifor Pharma will exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its dialysis facilities in the U.S. to meet their need for an HIF-based treatment for anemia associated with CKD. Fresenius Medical Care is the largest kidney dialysis provider in the U.S. and, in 2016, treated over 185,000 dialysis patients, or nearly 40% of the U.S. dialysis patients. This agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma. It is subject to the approval of vadadustat by the FDA and to the inclusion of vadadustat in a 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. Akebia, in collaboration with Otsuka, plans to commercialize vadadustat in other dialysis organizations and centers and in the non-dialysis market in the U.S.
“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 are pleased that Vifor Pharma has selected vadadustat as its exclusive HIF product for distribution to Fresenius Medical Care, one of the largest dialysis providers. We believe that this commitment provides significant further validation of vadadustat’s potential.”
Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat has not been approved by the FDA or any other regulatory authority.
Filed Under: Drug Discovery