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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)
Date:1/25/2013

ported with KAZANO include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.

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 Program
U.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 Diabetes
Type 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
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SOURCE Takeda Pharmaceutical Company Limited
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