Top-line Results from Global Phase 3 Program of Vadadustat, a Drug Candidate for Treatment of Renal Anemia due to Chronic Kidney Disease in Non-Dialysis Patients

Vadadustat achieved primary and secondary efficacy endpoints of the PROTECT trial in patients with renal anemia who were not receiving dialysis2 The PROTECT did not meet primary safety endpoint of major adverse cardiovascular events (MACE) in patients with renal anemia who were not receiving dialysis2 Totality of data from this global PROTECT trial and recently completed INNOVATE trial are anticipated to support submission and regulatory approvals, first with the U.S. FDA in 202122 Otsuka Pharmaceutical Co., Ltd. announces that its collaborator, Akebia Therapeutics, Inc., today announced topline data from the global, phase 3 clinical trials of Akebia`s vadadustat in non-dialysis-dependent, adult patients with renal anemia. Akebia Therapeutics is a fully integrated biopharmaceuticals company with nephrology-focused commercial and development capabilities and is headquartered in Cambridge, Massachusetts, U.S. Its investigational candidate vadadustat is an oral, hypoxia-inducible factor prolyl hydroxylase inhibitor. Vadadustat achieved the primary and key secondary efficacy endpoints in both of the two PROTECT studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36), and between baseline and the secondary evaluation period (weeks 40 to 52). Vadadustat did not meet the primary safety endpoint, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PROTECT studies.22 The efficacy and safety of vadadustat have been studied in four global, phase 3 efficacy and safety trials. The PROTECT program evaluated the efficacy and safety of vadadustat in non-dialysis-dependent patients with anemia, and the INNOVATE program, for which positive result were announced in May, evaluated vadadustat in dialysis-dependent patients. The control arm comparator for these non-inferiority studies was darbepoetin alfa, an injectable erythropoiesis stimulating agent (ESA).22 Akebia noted in its announcement that vadadustat's cardiovascular safety within non-dialysis patients is supported by the totality of data from its global Phase 3 program (PROTECT and INNOVATE), including additional analyses in key regions and specific patient sub-populations. Akebia plans to submit a New Drug Application to the U.S. Food and Drug Administration, for both dialysis and non-dialysis indications, as early as possible in 2021. Otsuka, in close collaboration with Akebia, is preparing to submit a Marketing Authorization Application to the European Medicines Agency, after the U.S. submission.22 The full dataset from Akebia's global Phase 3 program for vadadustat is expected to be communicated at an upcoming medical congress and in medical journals. About the collaboration between Otsuka and Akebia In 2016, the two companies signed a Collaboration and License Agreement for vadadustat in the U.S. The companies subsequently signed a Collaboration and License Agreement in 2017 for vadadustat in certain other areas. Otsuka has exclusive rights to market this drug in Europe, Canada, Australia, China and certain other areas, but excluding Japan and Latin America.* *Countries other than Japan and specific other Asian countries licensed by Akebia to Mitsubishi Tanabe Pharma Corporation

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