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Takeda Submits a New Drug Application for Trelagliptin Succinate (SYR-472) in Japan for the Treatment of Type 2 Diabetes

March 7, 2014

Osaka, Japan, March 7, 2014 –Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has submitted a New Drug Application ("NDA") to the Japanese Ministry of Health, Labour and Welfare fortrelagliptin succinate (development code: SYR-472), a treatment for type 2 diabetes.

Trelagliptin succinate, discovered by Takeda California, Inc., Takeda's wholly-owned subsidiary located in San Diego, California, is a once-weekly dipeptidyl peptidase-IV (DPP-4) inhibitor. It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones* that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.

This application is based on the safety and efficacy results of multiple clinical phase III studies in patients with type 2 diabetes in Japan. The efficacy of once-weekly trelagliptin succinate was confirmed in all studies, in addition to a good safety and tolerability profile. Trelagliptin succinate controls blood glucose levels effectively with single weekly dosing, and is expected to contribute to improvement in drug adherence of patients.

We will continue to collaborate closely with the health authorities so that we can provide this new treatment option to meet a variety of needs of patients with type 2 diabetes as well as healthcare providers as soon as possible.                                                                          
* An insulinotropic gastrointestinal hormone