Akebia Therapeutics, Vifor Pharma Expand License Agreement For Vadadustat

(RTTNews) - Akebia Therapeutics, Inc. (AKBA) and Switzerland-based Vifor Pharma Group announced Tuesday that the companies have amended the terms of their license agreement to sell vadadustat to Fresenius Medical Care (FMS) North America dialysis clinics in the United States, subject to its approval by the U.S. Food and Drug Administration.

Vadadustat is an oral hypoxia-inducible factor or HIF prolyl hydroxylase inhibitor currently in global Phase III development for the treatment of anemia due to chronic kidney disease or CKD.

Under the terms of the agreement signed in May 2017, Akebia granted Vifor Pharma a license to sell vadadustat to Fresenius Medical Care North America for use solely within its dialysis clinics in the U.S., subject to FDA approval. The license has now been amended to allow Vifor Pharma to also sell vadadustat to certain third-party dialysis organizations, for use in the U.S., thereby expanding the potential opportunity for vadadustat under the agreement to up to 60% of U.S. dialysis patients.

Under the terms of the amended agreement, Akebia is eligible to receive an additional $5 million payment, which means Akebia is eligible to receive a total payment of $25 million from Vifor Pharma upon approval of vadadustat by the FDA and the earlier of CMS's determination that vadadustat will be reimbursed under the TDAPA or included in the ESRD bundle.

The license, which is subject to vadadustat's approval by the FDA and inclusion in the Centres for Medicare & Medicaid (CMS) End Stage Renal Disease Prospective Payment System, will now also be effective during the Transitional Drug Add-on Payment Adjustment (TDAPA) two-year period that is expected to precede the ESRD bundle period.