Otsuka Pharmaceutical Co., Ltd.

May 13, 2022

Announcement of Termination of Global License Agreements for Renal Anemia
Treatment with Akebia Therapeutics, Inc.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has decided to terminate its global license agreements with Akebia Therapeutics, Inc. (Akebia) for vadadustat (generic name), under development as an oral treatment for anemia associated with chronic kidney disease (renal anemia). These licenses were signed in in December 2016 for the U.S. and April 2017 for Europe and other regions.

Otsuka and Akebia had been co-developing vadadustat for renal anemia, however in March this year, Akebia received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). As a result, Otsuka has decided to terminate its co-development of vadadustat and has notified Akebia of the termination of its global license agreements.

Otsuka is expanding globally in the cardiovascular and renal therapeutic areas as one of its priority therapeutic areas. Otsuka will continue its vigorous research programs on new treatments for patients with unfulfilled medical needs who eagerly await new treatment choices.