Takeda Launches Phase III Clinical Trial in Asia for "TAK-875", a Potential Diabetic Treatment

- It is a Multi-National Clinical Trial Joined by Five Countries/Territories in Asia -- The First Time Takeda has Developed Medicines in Asia in Parallel with the Rest of the World

- The Trial Hopes to Show that TAK-875 Can Provide Excellent Blood Sugar Control but with a Very Low Risk of Hypoglycaemia

Takeda Global Research & Development Center (Asia) Pte. Ltd. (TGRD Asia) today announced the initiation of a phase III clinical trial for TAK-875, a class of potential treatment for type-2 diabetes, in five countries/territories in the Asia Pacific region, including South Korea, mainland China, Taiwan, Australia and New Zealand. For Takeda in Asia, this is the first time a phase III clinical trial has started in parallel with the rest of the world.

The phase III clinical trial will be conducted for 24 weeks by administering TAK-875 25mg and 50mg to patients with type-2 diabetes in a comparison with placebo. The total planned number of patients in Asia in this study is 750. TAK-875 is a new treatment for type-2 diabetes that works on GPR40, a G-protein-coupled receptor (GPCR) that appears in insulin-secreting cells in the pancreas. It is hoped that TAK-875 will provide the benefit of reducing blood sugar levels, while reducing the risk of hypoglycemia. Hypoglycaemia (low blood sugar) is a serious and sometime life-threatening side effect of many standard diabetes medications.

Including this particular study above, other Asian countries/territories will also participate in global studies involving more than 2,500 patients. These countries/territories include Malaysia, Thailand, the Philippines and Hong Kong SAR.

According to results of a Phase II clinical trial published in The Lancet (Note 1), a research team at University of Michigan Medical College administered TAK-875 to 303 patients among 426 adult patients with diabetes whose blood sugar was neither controlled by metformin nor dietary therapy. The remaining patients were given placebo (61 patients) and another diabetes treatment (glimepiride, 62 patients). An observation after 12 weeks found that blood sugar in patients who received TAK-875 was significantly reduced by a similar amount to those in the glimepiride group. However, significant difference was observed in the rate of hypoglycemia, which was 19% in patients who received glimepiride and 2% in patients who received TAK-875.

Dr James Garner, General Manager for TGRD Asia said, "We are very pleased and excited that the TAK-875 study has entered Phase III trials in this region. The data published in The Lancet is very encouraging and TAK-875 is a potential therapy for the treatment of type 2 diabetes in the future. Patients are central to our focus and Takeda remains committed to developing new therapies and working to improve medical care in this very challenging area."

Note:

1. The Lancet, Volume 379, Issue 9824, Pages 1403 - 1411, 14 April 2012

About Takeda Global Research & Development Center (Asia) Pte. Ltd.

Headquartered in Singapore, Takeda Global Research & Development Center (Asia) Pte. Ltd. (TGRD Asia) is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. Fully integrated into the global development organisation, TGRD Asia serves as a regional hub for non-oncology clinical development. TGRD Asia seeks to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular diseases, respiratory and immunology, central nervous system diseases and other therapeutic areas. For more information on Takeda, visit www.takeda.com .

Contact:

Sheo S. Rai

Takeda Global Research & Development Center (Asia) Pte. Ltd.

Tel: +65-6521-2241

Email: [email protected]

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