Ahead of an FDA decision for its potential first-in-class anemia drug vadadustat, Akebia Therapeutics has expanded a licensing deal with Vifor Pharma. The deal puts Akebia in a better commercial situation before its possible rivalry against GlaxoSmithKline.
An updated agreement now allows Vifor to sell vadadustat at additional independent dialysis organizations, Akebia said Tuesday. Under their prior deal, Vifor could market the med at its semi-affiliated Fresenius Kidney Care Group’s dialysis clinics and other third-party facilities in the U.S.
With the revision, Vifor has agreed to make an additional equity investment of $20 million in Akebia. The Swiss company will also contribute $40 million as “working capital”—which will be returned over time—to help fund the manufacturing costs of vadadustat. That’s on top of a $25 million payment the two have previously agreed on that’s payable upon FDA approval and reimbursement coverage from the Centers for Medicare & Medicaid Services.
The deal upgrade is “confidence-inspiring” for vadadustat as the FDA is scheduled to decide on its use for anemia caused by chronic kidney disease in both dialysis-dependent and nondialysis-dependent patients by March 29, BTIG analyst Robert Hazlett wrote in a note to clients. If approved, vada could be the first in the novel oral drug class of HIF-PH inhibitors to land on the U.S. market. The drug has already been cleared in those indications in Japan and sold under the brand name Vafseo by Akebia’s local partner Mitsubishi Tanabe Pharma.
The first-in-class title could have belonged to FibroGen and AstraZeneca’s roxadustat, but cardiovascular safety signals triggered worries at the FDA, leading to a rejection in August.
Vada’s data at least look solid in the dialysis-dependent population, which represents a billion-dollar market opportunity in itself, Hazlett noted. In the dialysis group, vada matched up to Amgen’s Aranesp in a phase 3 trial on the major adverse cardiovascular event (MACE) marker without any safety signals that have cropped up in roxa’s trial.
In an interview with Fierce Pharma last year, Akebia CEO John Butler expressed confidence in vada’s chance of approval in the dialysis population.
The Vifor deal could cover 60% of U.S. dialysis patients through the Swiss company’s existing relationships. Akebia and partner Otsuka are still responsible for the remainder of the U.S. dialysis market and the nondialysis population. The two partnerships “provide a solid commercial footprint” for vada, especially for dialysis patients, Hazlett said.
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But in the nondialysis group, vada missed its cardio safety endpoint against Aranesp, a failure that Akebia has attributed to imbalances in ex-U.S. trial sites.
Vada’s nondialysis flop appears to give GSK’s daprodustat an edge. That rival HIF-PH inhibitor has succeeded in both dialysis and nondialysis patients, and GSK now plans filings in the U.S. and EU in the first half of this year.
Besides GSK’s dapro, AstraZeneca and FibroGen are also exploring the possibility of an additional clinical trial to enable a regulatory path for roxa with the FDA.