Date: 2017-05-15

Type of information: Licensing agreement

Compound: vadadustat

Company: Akebia Therapeutics (USA - MA) Vifor Pharma (Switzerland) Fresenius Medical Care (Germany)

Therapeutic area: Kidney diseases - Renal diseases

Type agreement: licensing

Action mechanism: hypoxia inducible factor (HIF) inhibitor. Vadadustat (AKB-6548) is a potent Hypoxia-inducible factor-proline dioxygenase inhibitor. It works by inhibiting hypoxia inducible factor-prolyl hydroxylase (HIP-PH), leading to stabilization and increased levels of HIF?. In turn HIF? improves production of hemoglobin and red blood cells (RBCs), while maintaining normal levels of erythropoietin (EPO) in patients.

Disease: anemia associated with chronic kidney disease

Details: • On May 15, 2017, Akebia Therapeutics and Vifor Pharma 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 FDA. Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is currently in Phase 3 development for the treatment of anemia associated 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 chronic kidney disease.    

Financial terms: 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.

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