May 18th, 2020

Co-marketing agreement concerning Vadadustat (MT-6548)
for renal anemia in Japan with Fuso Pharmaceuticalin hemodialysis and peritoneal dialysis patients
Mitsubishi Tanabe Pharma Corporation (MTPC, Head Office: Chuo-ku, Osaka;
President & Representative Director: Hiroaki Ueno) today announced that MTPC
and Fuso Pharmaceutical Industries Ltd. (Fuso Pharmaceutical, Head Office: Chuoku, Osaka; President & Representative Director: Mikio Toda) concluded a comarketing agreement concerning vadadustat (MT-6548) which is an oral hypoxiainducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of renal
anemia currently has submitted to the Ministry of Health, Labour and Welfare in
Japan in hemodialysis and peritoneal dialysis patients on May 7th, 2020.
In Japan, it is estimated that around 13 million people are suffering from chronic
kidney disease (CKD)*. It is reported that renal anemia develops from an earlystage of CKD and its frequency increases as CKD progresses**.
Symptoms associated with anemia include fatigue, shortness of breath, insomnia,
headache, and decreased energy, which may decrease a patient's quality of life
(QOL). Renal anemia can present prior to dialysis and at any time during
hemodialysis or peritoneal dialysis.
Injectable erythropoiesis stimulating agent (ESA) is currently the standard of care.
Vadadustat would provide patients with a once-daily treatment option and has thepotential to set a new oral standard of care for the treatment of renal anemia.
MTPC are confident that by partnering with Fuso Pharmaceutical, which has
strength in the dialysis field, we can provide appropriate information to more
healthcare professionals.
MTPC has been providing antidiabetic drugs with different mechanisms of action
to patients with diabetes and having a track record in the field of diabetes. As partof strengthening this area, MTPC newly established the Diabetes and Renal
Product Marketing Department in April this year.
Through this collaboration, the two companies will contribute to the pre-dialysis
storage period, peritoneal dialysis, and treatment of renal anemia for hemodialysis
patients.
Mitsubishi Tanabe Pharma will continue providing appropriate pharmaceuticalinformation and strive to add new value to medical practice by bridging thediabetes area with the renal area.
1/2

*Japanese Society of Nephrology, Evidence-based Clinical Practice Guideline for CKD
2018**Kohagura K, et al. Prevalence of anemia according to stage of chronic kidney disease
in a large screening cohort of Japanese. Clin Exp Nephrol. 2009

Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119

◆Reference◆
About Vadadustat
Vadadustat, in-licensed from Akebia Therapeutics, Inc., is an oral hypoxiainducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3
development for the treatment of renal anemia. Vadadustat’s proposedmechanism of action is designed to mimic the physiologic effect of altitude on
oxygen availability. At higher altitudes, the body responds to lower oxygen
availability with increased production of HIF, which induces endogenous
erythropoietin production to increase red blood cell production and, ultimately,improve oxygen delivery. Vadadustat is an investigational therapy and is not
approved by the U.S. Food and Drug Administration or any other regulatory
authority.

2/2