Vifor Pharma Group and Akebia Therapeutics have entered an exclusive license agreement to sell Vadadustat to Fresenius Medical Care dialysis clinics located in the US after securing approval from the US Food and Drug Administration (FDA).
The deal also states that Vifor Pharma will make a $50m equity investment in Akebia at $14 per share.
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Currently in Phase III development, Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabiliser designed to treat anaemia related to chronic kidney disease (CKD).
The drug is yet to receive approval from the FDA and other regulatory authorities.
Vifor Pharma executive committee president and chief operating officer Stefan Schulze said: “Vadadustat could represent a significant advancement in the treatment of renal anaemia, with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease.
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“We believe that Vadadustat may also be a potential solution for hypo-responder patients who do not respond well to erythropoiesis-stimulating agents.
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By GlobalData“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 agreement, Vifor Pharma will exclusively distribute Vadadustat to Fresenius Medical Care North America to be used only for dialysis in the US, which will fulfil the need for an HIF-based treatment for anaemia associated with CKD.
The deal will see Akebia receive $20m from Vifor Pharma, subject to the FDA’s approval of Vadadustat and its inclusion in a bundled reimbursement model.
Akebia, along with its US collaborator Otsuka, intends to commercialise Vadadustat in other dialysis organisations within the country.
Anaemia occurs when the body is unable to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production.
People above the age of 60 affected with CKD are at high risk of becoming affected with anaemia.
