giant GlaxoSmithKline (GSK 40.63, +0.12, +0.3%) posts a modest
advance after announcing a strategic collaboration with Kyowa Hakko Kirin Co.,
Ltd. for the future commercialization of daprodustat in Japan.
Daprodustat is an emerging treatment alternative for anemia associated with chronic kidney disease. In late October the company announced phase III results for daprodustat and the treatment met its primary endpoint of “of non-inferiority to darbepoetin alfa IV injection, as measured by mean haemoglobin levels over Weeks 40 to 52." Daprodustat is not approved as a treatment for anaemia associated with CKD or any other indication anywhere in the world. Results from the final Japanese phase 3 study in non-dialysis dependent patients are anticipated in 1H2019, with filing anticipated in 2H2019.
GSK has an ongoing global phase 3 registration programme in two branches: ASCEND-D and ASCEND-ND; for the D study, recruitment has completed, and results are anticipated in 2020. For the ND study recruitment remains ongoing and results are anticipated in 2020. Both studies, the co-primary endpoints are “time to first occurrence of major adverse cardiovascular events (MACE)” and “mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52).”
The studies will assess whether daprodustat is non-inferior to recombinant human erythropoietin and its analogues on these endpoints as the primary analysis. If non-inferiority of the primary analysis is met, superiority will be assessed for the MACE endpoint. Basically, if daprodustat is shown to be a viable alternative to existing treatments, or even better than them, the endpoint will be met.
Under the terms of the agreement, GlaxoSmithKline will be responsible for completion of the ongoing phase 3 clinical program and regulatory submissions for marketing authorization in Japan. Distribution of daprodustat will be exclusively conducted by Kyowa Hakko Kirin in the Japan market. Launch activities, including engagement of healthcare professionals and commercial activities, are expected to be conducted jointly by Kyowa Hakko Kirin and GSK.
The financial details of the Kyowa Hakko Kirin Co., Ltd. deal were not being disclosed.
GSK now boasts gains of 14.5% on the year as a strong start to the year has set up well for summer and fall consolidation. Shares still trade above both the 50-day (39.98) and 200-day (39.80) simple moving averages.