Akebia and Vifor Pharma Announce Exclusive License Agreement to sell Vadadustat in US clinics
Upon the approval from the FDA to sell vadadustat to Fresenius Medical Care dialysis clinics in the US, Akebia Therapeutics and Vifor Pharma Group entered into an exclusive license agreement. 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). Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share.
Vifor Pharma’s President of the Executive Committee and COO, Stefan Schulze said that 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. They believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents. This transaction strengthens the nephrology product portfolio of Vifor Pharma, and is consistent with their 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 a 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 approval of vadadustat by the FDA and 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.
Akebia President and CEO, John P. Butler said that this agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch. They 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. They believe that this commitment provides significant further validation of vadadustat’s potential.