Dive Brief:
- Akebia Therapeutics, Inc. announced a licensing deal with Vifor Pharma Group, giving Vifor exclusive U.S. distribution rights to vadadustat — after approval from the Food and Drug Administration — to treat anemia associated with chronic kidney disease.
- The collaboration will give Akebia exclusive access to distribute vadadustat, an oral hypoxia-inducible factor (HIF), to Vifor’s Fresenius Medical Care dialysis units, which serve 40% of U.S. dialysis patients.
- Vifor invested $50 million in Akebia as part of the deal through the purchase of 3.6 million shares, and its use of vadadustat is expected to expand market share for Akebia as it seeks to rapidly bring the drug to nephrology patients.
Dive Insight:
The collaboration will give Akebia exclusive access to the 185,000 dialysis patients treated each year through Fresenius Medical Care.
As part of the collaboration, Vifor will provide a $20 million payment to Akebia upon FDA approval of vadadustat, which is currently in Phase 3. The deal is structured as a profit sharing agreement, and Akebia’s revenue from the collaboration will be shared with Otsuka Pharmaceutical Co. Ltd, Akebia’s U.S. collaborator. Akebia and Otsuka plan to commercialize vadadustat through other dialysis centers, in addition to those owned by Vifor, as well as non-dialysis U.S. markets.
"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 CEO of Akebia.
Valdosta treats anemia by increasing the production of HIF, which boosts red cell production and increases oxygen levels. Current anemia treatments for people with chronic kidney disease are limited to injectable recombinant erythropoiesis stimulating agents (ESAs), which are associated with inconsistent responses and safety risks. Two phase 3 studies of vadadustat in dialysis and non-dialysis patents are underway.
Vadadustat is being marketed as a treatment that could potentially change the standard of care for patients with anemia from chronic kidney disease. Anemia associated with chronic kidney disease affects approximately 1.8 million patients in the U.S.