GSK and Kyowa Hakko Kirin will together commercialize in Japan the treatment of chronic kidney disease related anaemina, which GKS is currently developing in phase 3.
According to the financially undisclosed agreement announced on Thursday, GSK will finalize th eclinical programme of Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. GSK will also be responsible and regulatory submissions for marketing authorisation in Japan.
Kyowa Hakko Kirin will have exclusive distribution rights in Japan, while the companies will share launch activities.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “We anticipate making a regulatory submission to the Japanese Ministry of Health, Labour and Welfare in 2019 and if approved, we believe daprodustat would be an important new oral treatment option for Japanese patients with anaemia associated with CKD. We look forward to working with Kyowa Hakko Kirin, given their extensive experience in this area, to successfully launch and commercialise daprodustat in Japan.”
Wataru Murata, Executive Officer, Director of Corporate Strategy & Planning Department of Kyowa Hakko Kirin, said: “With this collaboration, we look to expand our existing product portfolio in Nephrology and meet medical needs by providing more treatment options for patients suffering with anaemia associated with CKD.”