LONDON (Alliance News) - GlaxoSmithKline PLC said Thursday it has signed a strategic commercialisation deal for its anaemia drug Daprodustat with Japanese firm Hakko Kirin Co Ltd.
Financial details of the Japanese commercialisation deal have not been disclosed.
Pharma heavyweight GSK will be responsible for completing the ongoing phase three clinical programme and regulatory submissions required to achieve marketing authorisation in Japan
Life sciences company Hakko Kirin will then distribute Daprodustat to the Japanese market on an exclusive basis.
Hakko Kirin and GSK will jointly conduct launch activities, such as healthcare professional engagement.
Daprodustat is used to treat anaemia in patients with chronic kidney disease, who are more prone to anaemia. Symptoms of patients with anaemia associated with chronic kidney disease include palpitation, dizziness, fatigue, and shortness of breath.
Daprodustat is not currently approved as an anaemia treatment in chronic kidney disease patients or for any other indication. However, positive results from two phase three studies in kidney dialysis patients were recently announced.
In addition, results from a final phase three Japanese study of patients who are not dependent on dialysis are expected in the first half of 2019.
A global phase three registration programme for Daprodustat in anaemic kidney disease patients is ongoing. This includes the Ascend-D trial, which will enrol roughly 3,000 dialysis-dependent patients, and Ascend-ND trial which will enrol approximately 4,500 non-dialysis patients.
Shares in GSK were up 0.5% at 1,583.60 pence on Thursday morning.
Glaxosmithkline (GSK)