Press Release
Tokyo, March 23, 2021

JT Receives Approval for Additional Indication forIron Deficiency Anemia for Riona® and Promotion to Start in Japan

Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii)(TSE:4551) announced today that JT received approval for an additional indication ofiron deficiency anemia (IDA) (hereinafter the "New Indication") for Riona® Tablets
250mg (generic name in Japan: ferric citrate hydrate, development code: JTT-751,
hereinafter "Riona®"). JT already has obtained manufacturing and marketing approvalfor Riona® which is being distributed by Torii as a treatment for improvement ofhyperphosphatemia in patients with chronic kidney disease in Japan.
Starting today, Torii and ASKA Pharmaceutical Co., Ltd. (ASKA) (TSE:4514) jointly
engage in the marketing of Riona®’s New Indication under the co-promotion agreement,
dated June 1, 2020, concerning the New Indication for Riona®. Torii will mainly focus onpromoting toward medical institutions with chronic kidney disease-related departments,
such as nephrology and dialysis, while ASKA will mainly focus on medical institutions
with obstetrics and gynecology.
JT, Torii and ASKA expect Riona® to be a new option to help patients with IDA in Japan.

Outline of approval(The additional indication related to this approval is as underlined below.)
Product Name:
Indications:

Riona® Tablets 250mg Generic Name:
Ferric Citrate Hydrate
Improvement of hyperphosphatemia in patients with chronic kidneydisease, Iron Deficiency Anemia
Dosage and Administration:
For improvement of hyperphosphatemia in patients with chronic kidney disease;
The recommended starting dose for adult patients starts at 500 mg offerric citrate taken orally three times daily immediately after meals.
Thereafter, the dose should be adjusted as appropriate depending on
the degree of symptoms and serum phosphorus concentration. Themaximum daily dosage is 6,000 mg.

For patients with iron deficiency anemia;
The usual adult dosage for oral use begins at 500 mg of ferric citrate
once daily immediately after meals. Thereafter, the dosage should beadjusted based on the degree of symptoms. The maximum dosage is
500 mg twice daily.

ABOUT Riona® Tablets 250mg“Riona® Tablets 250mg” is approved and marketed for the treatment ofhyperphosphatemia in adult patients with chronic kidney disease (CKD) both ondialysis and not on dialysis in Japan. JT and Torii acquired the exclusive rights in Japanfor its development and commercialization of Riona® under the agreement dated
September 26, 2007 with Keryx Biopharmaceuticals, Inc., a wholly owned subsidiary ofAkebia Therapeutics, Inc. JT received approval for Riona® on January 17, 2014 andTorii has been promoting and distributing products Riona® since May 12, 2014.
In the United States, ferric citrate is approved and marketed by Akebia Therapeutics,
Inc. under the trade name Auryxia® for the control of serum phosphorus levels in adultpatients with CKD on dialysis and for the treatment of IDA in adult patients with CKD
not on dialysis.

ABOUT Iron Deficiency Anemia (IDA)
IDA is the most frequent anemia, which is caused by decreasing hemoglobin
production due to iron deficiency. IDA involves symptoms of anemia with palpitations
and shortness of breath, as well as pica, fatigability, etc., which can lead to thedecrease in the patient's quality of life. Treatments for IDA include the ironsupplementation and the correction of underlying cause..

Contact for Japan Tobacco Inc.
Media and Investor Relations Division
Japan Tobacco Inc. Tokyo
E-mail: jt.media.relations@jt.com
Tokyo: +81-3-6636-2026
Contact for Torii Pharmaceutical Co., Ltd.
Corporate Planning Department (Public Relations)
Torii Pharmaceutical Co., Ltd
E-mail: webmaster@torii.co.jp
Tokyo: +81-3-3231-6814

Contact for ASKA Pharmaceutical Co., Ltd.
Corporate Planning Department
ASKA Pharmaceutical Co., Ltd.
E-mail: kouhou@aska-pharma.co.jp
Tokyo: +81-3-5484-8366