March 24, 2014
To Whom It May Concern
Company Name: Taisho Pharmaceutical Holdings Co., Ltd. Head Office: 3-24-1, Takada, Toshima-ku, Tokyo Representative: Akira Uehara, President and CEO
(First Section of the TSE: Code 4581)
Contact: Masaki Tsuboi, General Manager
Public Relations Section
(Tel: +81-3-3985-1115)

Acquisition of Manufacturing and Marketing Approval in Japan for SGLT2 Inhibitor Lusefi® Tablets 2.5 mg and Lusefi® Tablets 5 mg

Taisho Pharmaceutical Holdings Co., Ltd. has announced that its consolidated subsidiary Taisho Pharmaceutical Co., Ltd. ("Taisho Pharmaceutical") [Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara] today received manufacturing and marketing approval of the SGLT2 inhibitor Lusefi® tablets 2.5 mg and Lusefi®
tablets 5 mg (Development Code: TS-071; generic name: "luseogliflozin hydrate"; hereinafter "Lusefi®") from
the Ministry of Health, Labour and Welfare for the indication of Type 2 diabetes mellitus. Lusefi® was created by
Taisho Pharmaceutical.
Lusefi® is a drug with a new mechanism of action that selectively inhibits sodium-glucose cotransporter 2 (SGLT2). It lowers blood glucose levels by inhibiting reabsorption of glucose in the renal tubule, thus increasing urinary glucose excretion.
As a result of Phase 3 clinical trials conducted in respect of Type 2 diabetes patients in Japan, these trials confirmed that Lusefi® demonstrates an excellent effect of blood glucose improvement in monotherapy and in combined administration with the six existing types of oral hypoglycemic agents, and that the effect was maintained for 52 weeks without attenuation. At the same time, the studies confirmed Lusefi®'s excellent safety profile. Furthermore, as a result of analysis of the secondary endpoints of both studies, Lusefi® was found to significantly improve the blood glucose levels when fasting and also lower body weight.
The number of people strongly suspected to have diabetes in Japan is currently estimated to be around 9 million. Since Lusefi® has a different mechanism of action than existing oral hypoglycemic agents, there are high hopes for Lusefi® to become a novel Type 2 diabetes mellitus treatment that can be administered in monotherapy as well as in combination with a broad range of other drugs.
Through the marketing of Lusefi®, an oral hypoglycemic agent with a new mechanism of action, Taisho
Pharmaceutical hopes to provide a new diabetes treatment option to many more patients. Outline of Approval Details

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