Takeda Receives Simultaneous European Marketing Authorization for Three New Type 2 Diabetes Therapies, Vipidia[TM] ▼ (al

        
        - as an adjunct to diet and exercise to improve glycemic control in adult
          patients, inadequately controlled on their maximal tolerated dose of metformin alone,
          or those already being treated with the combination of alogliptin and metformin
        - in combination with pioglitazone (i.e. triple combination therapy) as an
          adjunct to diet and exercise in adult patients inadequately controlled on their
          maximal tolerated dose of metformin and pioglitazone
        - in combination with insulin (i.e. triple combination therapy) as an adjunct to
          diet and exercise to improve glycemic control in patients when insulin at a stable
          dose and metformin alone do not provide adequate glycemic control

The alogliptin and metformin fixed-dose combination is currently available in the US under the brand name Kazano.

About Incresync (alogliptin and pioglitazone) fixed dose combination[3]

Alogliptin and pioglitazone is a FDC therapy for the treatment of type 2 diabetes, which combines 25 mg alogliptin and 45 mg pioglitazone in a single tablet, taken once daily. Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:

        
        - as an adjunct to diet and exercise to improve glycemic control in adult
          patients (particularly overweight patients) inadequately controlled on pioglitazone
          alone, and for whom metformin is inappropriate due to contraindications or intolerance
        - in combination with metformin (i.e. triple combination therapy) as an adjunct
          to diet and exercise to improve glycemic control in adult patients (particularly
          overweight patients) inadequately controlled on their maximal tolerated dose of
          metformin and pioglitazone

The alogliptin and pioglitazone fixed-dose combination is currently available in Japan under the brand name Liovel and in the US as Oseni.

About type 2 diabetes

        
        - In 2012, 371 million people were living with type 2 diabetes worldwide.
          That number continues to grow and by 2030 it is estimated to rise to 552 million[15]
        - In 2011, the number of people with diabetes in Europe was estimated to be 55
          million[15]
        - The number of type 2 diabetes patients is increasing in every country[15]
        - In 2011, one in 10 deaths in adults in the Europe are attributed to diabetes,
          representing close to 600,000 people[15]
        - Estimates indicate that more than EUR 99 billion* was spent on healthcare due
          to diabetes in the European region in 2011, accounting for almost one-third of global
          healthcare expenditures due to diabetes[15]
        - Because of the chronic nature of this disease, combination therapy is almost
          uniformly required to maintain diabetic control over many years of therapy[16]

*Based on conversion of USD 131 billion,[15] where 1 EUR = 1.32942 USD as at 12 August 2013

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda 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, http://www.takeda.com.

References

        
        1) Summary of product characteristics for Vipidia. Takeda Pharmaceuticals
          GmBH.
        2) Summary of product characteristics for Vipdomet. Takeda Pharmaceuticals GmBH.
        3) Summary of product characteristics for Incresync. Takeda Pharmaceuticals
          GmBH.
        4) White, W.B. et al. (2013) Alogliptin after Acute Coronary Syndrome in
          Patients with Type 2 Diabetes. The New England Journal of Medicine. [online] nejm.org.
          Available from: http://www.nejm.org/doi/full/10.1056/NEJ...
        5) Del Prato S, Camisasca R et al. Durability of the Efficacy and safety of
          Alogliptin Compared to Glipizide over 2 Years When Used in Combination with Metformin.
          Poster #66-LB presented at the 73rd Scientific Sessions of the American Diabetes
          Association (ADA), Chicago, Illinois, June 21-25, 2013.
        6) DeFronzo RA, Fleck PR, Wilson CA, et al. Efficacy and safety of dipeptidyl
          peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate
          glycemic control. Diabetes Care 2008;31(12):2315-2317.
        7) Nauck MA, Ellis GC, Fleck PR, et al. Efficacy and safety of adding the
          dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type
          2 diabetes and inadequately controlled with metformin monotherapy: a multicentre,
          randomised, double blind, placebo-controlled study. Int J Clin Pract 2009;63(1):46-55.
        8) Pratley RE, Reusch JE-B, Fleck PR, et al. Efficacy and safety of the
          dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with
          type 2 diabetes: a randomised, double blind, placebo-controlled study. Curr Med Res
          Opin 2009;25(10):2361-2371.
        9) Rosenstock J, Rendell MS, Gross JL, et al. Alogliptin added to insulin
          therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or
          increased hypoglycaemia. Diabetes Obes Metab 2009;11:1145-1152.
          10) Pratley RE, Kipnes MS, Fleck PR, et al. Efficacy and safety of dipeptidyl
          peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately
          controlled by glyburide monotherapy. Diabetes, Obesity and Metabolism 2009;11:167-176.
          11) Pratley RE, Wilson CA and Fleck PR. Alogliptin plus metformin combination
          therapy vs alogliptin or metformin monotherapy for type 2 diabetes mellitus. Presented
          at the 48th Annual Meeting of the European Association for the Study of Diabetes,
          Berlin 2012. Poster 841-P.
          12) DeFronzo RA, Burant CF, Fleck PR, et al. Efficacy and tolerability of the
          DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin treated patients
          with type 2 diabetes. J Clin Endocrinol Metab 2012; 97(5):1615-1622.
          13) Bosi E, Ellis GC, Wilson CA, et al. Alogliptin as a third oral antidiabetic
          drug in patients with type 2 diabetes and inadequate glycaemic control on metformin
          and pioglitazone: a 52 week, randomized, double-blind, active-controlled,
          parallel-group study. Diabetes, Obes and Metab 2011;13(12): 1088-1096.
          14) Christopher R and Karim A. Clinical pharmacology of alogliptin, a dipeptidyl
          peptidase-4 inhibitor, for the treatment of type 2 diabetes. Expert Rev Clin Parmacol
          2009;2(6):589-600.
          15) International Diabetes Federation. IDF Diabetes Atlas, 5th edition.
          Brussels, Belgium. Last accessed August 2013, available at:
          http://www.idf.org/diabetesatlas.
          16) Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in
          type 2 diabetes: a patient centred approach. Position statement of the American
          Diabetes Association and the European Association for the Study of Diabetes. Diabetes
          Care 2012;35(6):1364-1379.

Date of preparation: September 2013

EUCAN/ALO/2013-10090

UK/VIP/1309/0052

CONTACT: Contacts: Investor relations and media enquiries: TakedaPharmaceuticals Company Limited, Corporate Communications Department,Telephone: +81-3-3278-2037; Takeda Pharmaceuticals International, Inc.,Elissa J. Johnsen, Telephone: +1-224-554-3185,Email:elissa.johnsen@takeda.com