US-based Akebia Therapeutics has entered into a development and commercialisation agreement with Mitsubishi Tanabe Pharma (MTPC) for vadadustat (formerly AKB-6548), an oral therapy that treats anaemia related to chronic kidney disease (CKD) in Japan and other countries in Asia.
As part of the deal, MTPC will pay a total of $100m for costs associated with the global Phase III programme for vadadustat, including $40m upon signing.
Akebia is also eligible to receive $250m in additional milestone payments, based upon achievement of certain development and sales milestones.
MTPC will also make tiered royalty payments, from low teens up to 20%, on sales of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and other Asian countries.
Akebia president and CEO John Butler said: "Vadadustat offers a new paradigm for the treatment of anaemia for CKD patients. This partnership with MTPC validates vadadustat’s therapeutic potential and helps ensure that its potential is realised in Asia.
"MTPC is one of the largest, most successful pharmaceutical companies in Japan with a substantial presence in these Asian markets.
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"They are committed to the development and commercialisation of innovative products, with a strategic focus on products for renal disease and diabetes, making them an ideal partner for Akebia."
The drug is designed to stabilise HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme.
Mitsubishi Tanabe Pharma CEO, president and representative director Masayuki Mitsuka said: "A safer treatment for managing anaemia related to chronic kidney disease remains a significant unmet need globally.
"We see great potential in vadadustat to advance the care of chronic kidney disease patients. We look forward to our collaboration with Akebia."
The company noted that the drug exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude.
The body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilisation and erythropoietin (EPO) production to increase RBC production and improve oxygen delivery.