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Takeda Submits a New Drug Application for the Fixed-Dose Combination of Nesina® and Metformin Hydrochloride for the Treatment of Type 2 Diabetes in Japan

September 28, 2015

Osaka, Japan, September 28, 2015 – Takeda Pharmaceutical Company Limited ("Takeda") (TSE: 4502) announced today that it has submitted a New Drug Application ("NDA") to the Ministry of Health, Labor and Welfare in Japan for the fixed-dose combination of Nesina® (generic name: alogliptin benzoate) and metformin hydrochloride (hereafter “metformin”) for the treatment of type 2 diabetes. Type 2 diabetes is the most common form of diabetes, affecting millions of people globally. Worldwide, there are 382 million people living with diabetes, and the International Diabetes Federation (IDF) predicts there will be 592 million people with the condition by 2035.

Nesina is a once-daily dipeptidyl peptidase-IV (DPP-4) inhibitor. It controls blood glucose levels by selectively 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. Metformin is a widely used as biguanide that controls blood glucose level primarily by inhibition of glucose production in the liver.

Prior to filing this application, Takeda had conducted a phase III multicenter, randomized, double-blind comparative trial in Japan involving a total of 374 type 2 diabetic patients with inadequate control with Nesina alone, where the combination of Nesina and metformin as once-daily dosing was evaluated for its efficacy and safety. In this study, the combination of Nesina and metformin as once-daily dosing was shown to be superior to Nesina alone in regard to the changes in HbA1c from baseline (primary endpoint) and to offer a comparable safety and tolerability profile to Nesina alone. The fixed dose combination of Nesina and metformin is the only combination of a DPP-4 inhibitor and metformin to offer once-daily dosing.

Toshio Heya, head of Takeda Development Center Japan, said “diabetes is a complex and highly progressive disease, and many patients fail to meet glycemic targets despite the variety of treatment options available. Flexibility of treatment based on the individual’s disease progression is the cornerstone of successful management of type 2 diabetes.

The introduction of Takeda’s multiple Type 2 diabetes therapies enables health care professionals to tailor a more customized treatment approach to meet their patients’ individual needs.”

*An insulinotropic gastrointestinal hormone

About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone. Takeda launched alogliptin benzoate, a DPP-4 inhibitor, in Japan in 2010. Since that time alogliptin benzoate has been launched in a variety of markets across the globe including the U.S., Italy, the United Kingdom, China, Mexico and South Korea. As diabetes becomes increasingly prevalent, Takeda remains focused on expanding access of alogliptin benzoate, especially in emerging markets like Brazil, Russia, and the Middle East. In 2015, Takeda launched Zafatek, a DPP-4 inhibitor for the treatment of Type 2 diabetes, in Japan. The company’s diverse diabetes portfolio of medications represent Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About Takeda
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.



Tsuyoshi Tada
Takeda Pharmaceutical Company Limited
E-mail: [email protected]