The company is entitled to receive a settlement fee of $55m and will assume responsibility for the marketing authorisation application (MAA) with the European Medicines Agency (EMA), initiated by Otsuka
Akebia Therapeutics has terminated its collaboration and license deal with Otsuka Pharmaceutical to retain its rights to vadadustat in the US and beyond.
Under the terms of the termination agreement, the US-based biopharmaceutical company is expected to receive a settlement fee of $55m from Otsuka.
In addition, it will regain the rights to vadadustat in the US, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories.
Vadadustat is a potential oral hypoxia-inducible factor prolyl hydroxylase inhibitor, designed to imitate the physiologic effect of altitude on oxygen availability.
Akebia chief executive officer John Butler said: “We continue to believe in the potential of vadadustat as an oral treatment for patients with anaemia due to chronic kidney disease, and we are pleased to be regaining the full rights to the product in these important markets.
“Otsuka has been a strong partner for many years, and we appreciate their desire to have an efficient transfer of the responsibilities back to Akebia.
“We plan to continue to pursue approval for vadadustat to make it available to patients in these territories, and we are excited about the potential additional value this brings to Akebia, as we continue to work to build the company into the future.”
Otsuka filed an initial marketing authorisation application (MAA) with the European Medicines Agency (EMA) for vadadustat to treat anaemia related to chronic kidney disease (CKD), in October last year.
In relation to the termination of collaboration, Otsuka and Akebia have agreed to transfer the MAA to Akebia through processes outlined by the EMA.
In addition, the drug is currently being reviewed by the regulatory authorities in the UK, Switzerland, and Australia through the Access Consortium.
Akebia has received a Complete Response Letter from the US Food & Drug Administration (FDA) for vadadustat, and intends to pursue the next regulatory steps in the US.
The company has signed a separate distribution agreement with Vifor Pharma, which is said to provide access to up to 60% of US dialysis patients.
Furthermore, Mitsubishi Tanabe Pharma has obtained development and commercialisation rights to vadadustat in Japan and certain other Asian counties.