July 3, 2017
Press release
Mitsubishi Tanabe Pharma Corporation
Daiichi Sankyo Co., Ltd.

Japan’s First DPP-4 Inhibitor / SGLT2 Inhibitor Combination Drug
Application approved in Japan for CANALIA® Combination Tablets, atype 2 diabetes mellitus treatment agent-Combination of selective DPP-4 inhibitor TENELIA® Tablets andSGLT2 inhibitor CANAGLU® TabletsOsaka and Tokyo, Japan (July 3, 2017) - Mitsubishi Tanabe Pharma Corporation(hereafter Mitsubishi Tanabe Pharma; Head Office: Chuo-ku, Osaka; President &Representative Director, CEO: Masayuki Mitsuka) and Daiichi Sankyo Co., Ltd.
(hereafter Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; Representative Director,
President & COO: Sunao Manabe) announced today that on July 3, 2017, Mitsubishi
Tanabe Pharma received manufacturing and sales approval for CANALIA®
Combination Tablets, a type 2 diabetes mellitus treatment agent that combines
selective DPP-4 inhibitor TENELIA® Tablets (generic name: teneligliptin) and SGLT2inhibitor CANAGLU® Tablets (generic name: canagliflozin), from the Japanese
Ministry of Health, Labour and Welfare. The approval is for an indication of type 2
diabetes mellitus.
Approved for the first time in Japan, CANALIA® Combination Tablets is a combination
drug that contains two ingredients, a DPP-4 inhibitor and a SGLT2 inhibitor. BothTENELIA® Tablets and CANAGLU® Tablets are type 2 diabetes mellitus treatment
agents originally discovered by Mitsubishi Tanabe Pharma in Japan. CANALIA®
Combination Tablets, a combination drug incorporating the above two constituents, isan orally-administered (once daily) agent that lowers blood-glucose levels based ontwo different mechanisms of action: inhibiting DPP-4 and thereby increasing insulin
release according to blood glucose levels; and inhibiting SGLT2 and thereby
promoting excretion of glucose into urine. Results of clinical trials conducted inJapanese T2DM patients who have inadequate glycemic control to TENELIA® Tablets
or CANAGLU® Tablets demonstrated efficacy, safety and good tolerability.
Use of CANALIA® Combination Tablets by patients with type 2 diabetes mellitus
whose blood glucose levels are stably controlled by concomitant treatment withTENELIA® Tablets and CANAGLU® Tablets will enhance convenience and improvemedication adherence. Use of CANALIA® Combination Tablets by type 2 diabetes
mellitus patients who have inadequate glycemic control to monotherapy withTENELIA® Tablets or CANAGLU® Tablets is also expected to result in improved
blood glucose control.
Currently, marketing of TENELIA® Tablets is conducted by Daiichi Sankyo, whereas
marketing of CANAGLU® Tablets is carried out by Mitsubishi Tanabe Pharma.
-1-Marketing of CANALIA® Combination Tablets will be conducted by Daiichi Sankyo,
and both companies will co-promote the product, as is the case with TENELIA®
Tablets and CANAGLU® Tablets.
Mitsubishi Tanabe Pharma and Daiichi Sankyo aim to contribute to the treatmentof patients with diabetes by maximizing the product values of the above three
agents in the diabetes treatment drug markets as well as by engaging in prompt
and appropriate promotion activities through the alliance between bothcompanies.

For further information, please contact:
Mitsubishi Tanabe Pharma Corporation

Daiichi Sankyo Co., Ltd.

Corporate Communications Department

Corporate Communications Department

TEL: +81-6-6205-5211

TEL: +81-3-6225-1126-2-