Vifor Pharma Group has obtained exclusive rights to sell Akebia Therapeutics‘ kidney-disease-related anti-anemia treatment vadadustat (AKB-6548) to Fresenius Medical Care dialysis clinics in the United States.
The licensing agreement will kick in when the Federal Drug Administration approves vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer, as a treatment for anemia associated with chronic kidney disease (CKD).
Key terms of the deal are Akebia receiving $20 million from Vifor, and its new partner buying $50 million worth of Akebia stock at $14 per share.
Anemia occurs when the body is unable to produce enough red blood cells because a progressive loss of kidney function has lowered oxygen levels. Deficient kidneys generate inadequate levels of erythropoietin, a hormone involved in red blood cell production.
Vadadustat uses the same mechanism to respond to lower oxygen levels that our bodies do when they adapt to less oxygen at higher altitudes. The body generates more HIF, which helps mobilize iron, and more erythropoietin to increase red blood cell production. Increased production improves oxygen delivery.
A Phase 2 clinical trial (NCT01381094) showed that vadadustat significantly increased levels of hemoglobin, an oxygen-carrying molecule in red blood cells. It also improved biomarkers of iron mobilization and use in patients with moderate and advanced CKD who have anemia.
Akebia is starting Phrase 3 trials of vadadustat in both non-dialysis-dependent and dialysis-dependent kidney patients.
“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,” Stefan Schulze, Vifor’s chief operating officer, said in a press release. “We believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents.”
The licensing agreement “strengthens the nephrology [kidney] 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,” Schulze said.
“This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch,” said John P. Butler, Akebia’s president and chief executive officer. “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.”