November 1, 2017

Notice of the Start of Japanese Phase 3 Clinical Studiesof the HIF-PH Inhibitor MT-6548 in Renal Anemia
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; President &Representative Director: Masayuki Mitsuka) has initiated a Japanese phase 3 clinicalstudy of the hypoxia inducible factor prolyl hydroxylase (HIF-PH) inhibitor MT-6548(generic name: vadadustat) in patients with renal anemia secondary to chronic
kidney disease (CKD) who are either not dependent on dialysis (NDD-CKD) or
receiving peritoneal dialysis (PD-CKD).
The study in patients with NDD-CKD is a randomized, open-label, comparative study
to demonstrate the efficacy and safety of MT-6548 using as a control drug theerythropoiesis-stimulating agent (ESA) darbepoetin alfa (genetical recombination),
which is the standard therapeutic medication. The therapeutic efficacy of MT-6548
in renal anemia will be evaluated by demonstrating the noninferiority of MT-6548 todarbepoetin alfa in the hemoglobin level improvement effect/switching from ESAand maintenance efficacy.
MT-6548 is an HIF-PH inhibitor that has been in-licensed from Akebia Therapeutics, aUS biopharmaceutical company located in the state of Massachusetts. In December
2015, Mitsubishi Tanabe Pharma signed an agreement with Akebia giving Mitsubishi
Tanabe Pharma exclusive development and marketing rights for MT-6548 in Japanand other countries in Asia. Akebia is currently conducting global phase 3 clinicalstudies of vadadustat in patients with anemia associated with CKD.
In Japan, it is an oral estimated that around 11 million people are afflicted with Stage
3 or higher CKD (CKD Treatment Guidelines), meaning that a great many persons
are suffering from anemia, including all the people who are receiving dialysis(around 320 thousand people, according to the Japanese Society for Dialysis
Therapy). These cases of anemia are caused by the progressive loss of kidney
function in patients with kidney disease, and the associated hypoxia results in a lossof the physiologic functions that regulate erythrocyte production. It is also believedthat if the anemia is left untreated, this results in progression of the CKD, and in aworsening of the patient’s overall health.
Mitsubishi Tanabe Pharma is proceeding to develop MT-6548 as a therapeutic
medication for renal anemia in order to be able to offer this treatment to patients inJapan by the end of FY2020.
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110
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About Vadadustat
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Global
Phase 3 development for the treatment of anemia related to chronic kidney disease.
Vadadustat exploits the same mechanism of action used by the body to adapt
naturally to lower oxygen availability associated with a moderate increase in altitude.
At higher altitudes, the body responds to lower oxygen availability with increased
production of HIF, which coordinates the interdependent processes of ironmobilization and erythropoietin production to increase red blood cell production and,ultimately, improve oxygen delivery.
About Akebia Therapeutics Inc.
Akebia Therapeutics is a biopharmaceutical company headquartered in Cambridge,
Massachusetts that is focused on providing innovative therapies to patients withCKD via the biology of HIF. Phase 2 clinical studies of an oral formulation ofvadadustat in the US, Akebia’s leading product, have been completed in both
NDD-CKD and DD-CKD, and global phase 3 studies are underway.
http://akebia.com/2/2