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Takeda Receives FDA Approval For Three New Type 2 Diabetes Therapies, NESINA (alogliptin) And Fixed-Dose Combinations OSENI (alogliptin And Pioglitazone) And KAZANO (alogliptin And Metformin HCl)

Takeda is committed to providing type 2 diabetes patients with treatment options that help address their needs, and is planning to commercially launch NESINA, OSENI and KAZANO in the summer of 2013.

Takeda's consolidated financial statements for the 2012 fiscal year will not be impacted by the FDA approvals.

Clinical Trial ProgramU.S.-based Takeda Global Research & Development Center, Inc. conducted worldwide placebo- and active-controlled clinical trials of NESINA involving more than 13,000 patients. The safety and efficacy of NESINA was studied as a once-daily monotherapy and in combination with several other classes of anti-diabetic medications, including biguanides, TZDs, insulin and sulfonylureas. In these studies, NESINA 25 mg, taken once daily, demonstrated clinically meaningful and statistically significant improvements in hemoglobin A1C compared to placebo.

Of the total number of patients included in the NESINA clinical trial program, more than 3,000 were included in the studies used to support the FDA approval of OSENI, and more than 4,000 were included in those to support the FDA approval of KAZANO. Study results indicated that alogliptin co-administered with either pioglitazone or metformin HCl produced significant improvements in glycemic control as compared to the respective monotherapies.

About Type 2 DiabetesType 2 diabetes is the most common form of diabetes affecting millions of people globally. In fact, more than 23 million people in the U.S. alone currently live with the disease. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. According to the International Diabetes Federation, the global health care expenditures for diabetes (both type 1 and 2) were estimated at $471.6 billion in 2012. By 2030, this number is projected to exceed $595 billion.

About NESINA, OSENI and KAZANONESINA is a DPP-4i for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4is slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application (NDA) for NESINA was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is available under the same brand name in Japan.

OSENI is an FDC therapy which combines alogliptin and pioglitazone in a single tablet, for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. Pioglitazone is a TZD that decreases insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for alogliptin and pioglitazone was approved in July 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name LIOVEL in Japan.

KAZANO is an FDC therapy for the treatment of type 2 diabetes, which combines alogliptin and metformin HCl in a single tablet. Metformin HCl is a biguanide, a widely used anti-diabetes medication that acts primarily by reducing the amount of glucose produced by the liver.

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