Akebia Therapeutics has found a new partner in Europe for oral anemia drug Vafseo in chronic kidney disease. But the deal is smaller than the company's prior pact with Otsuka.
Medice Arzneimittel Pütter has agreed to pay Akebia $10 million upfront and up to $100 million in commercial milestones for rights to Vafseo in Europe and Australia, Akebia said Thursday.
Vafseo, or vadadustat, recently gained approvals in the EU and the U.K., but only for dialysis-dependent patients with CKD-related anemia.
The scope of the Medice partnership is significantly smaller than Akebia’s prior deal with Otsuka. Back in 2016, Otsuka inked an agreement worth up to $1 billion for rights to the drug in the U.S. In 2017, the partners added Europe, China and other territories for a total value of up to $865 million.
But Otsuka bowed out of the deal last year after the FDA hit Vafseo with a complete response letter.
Akebia is now appealing the FDA’s decision and is asking the agency for an approval in dialysis-dependent patients. During its first-quarter report earlier this month, Akebia said it expects a response from the FDA within 30 days.
In the U.S., Akebia has said it intends to market Vafseo under a partnership with dialysis expert CSL Vifor—if the FDA changes its mind.
Medice also brings “extensive expertise in nephrology and an established European dialysis business,” Akebia said in its release. While Akebia retains rights to other potential indications, Medice has the right of first refusal for an expanded collaboration.
Vafseo is an oral HIF-PHI, a drug class that also includes AstraZeneca, Astellas and FibroGen’s Evrenzo, plus GSK’s Jesduvroq. The drugs hold the potential to offer a more convenient option for anemia patients than traditional erythropoietin stimulating agents. But the FDA rejected both Evrenzo and Vafseo over concerns about their cardiovascular side effects, among other safety problems.
For its part, Jesduvroq in February got a narrow approval in dialysis-dependent patients. As for Evrenzo, FibroGen and AZ have failed to find a pathway forward in the U.S., and their partnership looks in danger after the drug flopped in another indication.
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