Vifor Pharma and Akebia Therapeutics Announce Expansion of Licence Agreement

The Vifor Pharma Group and Akebia Therapeutics announced that the companies have amended the terms of their licence agreement to sell vadadustat to Fresenius Medical Care North America dialysis clinics in the United States, subject to its approval by the U.S. Food and Drug Administration (FDA).

Under the terms of the agreement signed in May 2017, Akebia granted Vifor Pharma a licence 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 licence has now been amended to allow Vifor Pharma to also sell vadadustat to certain third-party dialysis organisations, 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.

The licence, 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 (ESRD PPS), also referred to as the ESRD bundle, 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.

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.

Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor currently in phase-III development for the treatment of anaemia due to chronic kidney disease (CKD). Vifor Pharma and Akebia believe that vadadustat has the potential to set a new oral standard of care for patients with anaemia due to CKD.

Stefan Schulze, President of the Executive Committee and COO at Vifor Pharma said “We are very pleased to have amended our licence agreement with Akebia. We believe that vadadustat has the potential to play an important role in the future treatment of anaemia due to CKD and we will work closely with our strategic partner Fresenius Medical Care to maximise this opportunity.”

“We believe the expansion of this agreement reflects enthusiasm about our development program and the potential for vadadustat to treat anaemia due to CKD,” stated John P. Butler, President and Chief Executive Officer of Akebia Therapeutics, Inc. “We are excited to be building on our relationship with Vifor Pharma to facilitate access to vadadustat to a larger group of dialysis patients, subject to its approval by the FDA.”