May 23, 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: Makoto Funahashi, General Manager
Corporate Communications
(Tel: +81-3-3985-1115)

Launch of Selective 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 launched the selective SGLT2 inhibitor Lusefi® tablets 2.5 mg and Lusefi® tablets 5 mg
(hereinafter "Lusefi®") for the indication of Type 2 diabetes mellitus.
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 studies conducted in Japanese patients with Type 2 diabetes, these studies confirmed that Lusefi® demonstrated an excellent effect of blood glucose improvement in monotherapy and in combination with the six types of oral antidiabetic drugs. Glycemic control effect was sustained for up to 52 weeks. Throughout the studies, Lusefi® also demonstrated excellent safety profile.
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 antidiabetic drugs, 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 antidiabetic drugs.
Taisho Pharmaceutical discovered and developed Lusefi® and acquired manufacturing and marketing approval for the drug. Lusefi® will be marketed by Taisho Pharmaceutical Holdings Co., Ltd.'s consolidated subsidiary Taisho Toyama Pharmaceutical Co., Ltd. [Head Office: Toshima-ku, Tokyo; President: Akira Ohira] and Novartis Pharma K.K. [Head Office: Minato-ku, Tokyo; President: Dirk Kosche].
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Through the marketing of Lusefi®, a Type 2 diabetes mellitus treatment with a new mechanism of action, Taisho Pharmaceutical hopes to provide a new treatment option of Type 2 diabetes mellitus to many more patients.
[Reference]

Product name:

Lusefi® tablets 2.5 mg, Lusefi® tablets 5 mg

Generic name:

Luseogliflozin Hydrate

Indication:

Type 2 diabetes mellitus

Dosage and administration:

Ordinarily, the dosage for adults is 2.5 mg, taken orally once a day before or after breakfast. If the effect is insufficient, the dosage may be

increased to 5 mg, taken once a day, with close follow-up observation.

Package:

Lusefi® tablets 2.5 mg

100 tablets (10 tablets × 10 sheets)

Package:

Lusefi® tablets 2.5 mg

140 tablets (14 tablets × 10 sheets)

Package:

Lusefi® tablets 2.5 mg

500 tablets (10 tablets × 50 sheets)

Package:

Lusefi® tablets 2.5 mg

500 tablets (bottle)

Package:

Lusefi® tablets 5 mg

100 tablets (10 tablets × 10 sheets)

Package:

Lusefi® tablets 5 mg

140 tablets (14 tablets × 10 sheets)

Package:

Lusefi® tablets 5 mg

500 tablets (bottle)

Drug price:

Lusefi® tablets 2.5 mg

JPY 205.50 / tablet

Drug price:

Lusefi® tablets 5 mg

JPY 308.30 / tablet

Date of approval:

March 24, 2014

Date of drug price

listing:

May 23, 2014

Date of launch:

May 23, 2014


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