Takeda Receives Positive CHMP Opinions for Label Updates to Vipidia™ (alogliptin) and Fixed-Dose Combinations Vipdomet™ (alogliptin and metformin) and Incresync™ (alogliptin and pioglitazone)

"We're encouraged by the positive opinions for Vipidia, Vipdomet and Incresync as cardiovascular disease is the leading cause of morbidity and mortality in patients with Type 2 diabetes," said Elisabeth Genestin, MD, cardiometabolic medical affairs director, Europe & Canada, Takeda. "Having a robust data set demonstrating that alogliptin does not increase the risk of cardiovascular outcomes is important for the healthcare professionals who are treating people with Type 2 diabetes."

The most substantive change proposals include:

The CHMP/EMA opinions for Vipidia, Vipdomet, and Incresync will now be sent to the European Commission to update the respective product Commission Decisions.² The European Commission first granted Marketing Authorization for Vipidia, Vipdomet, and Incresync in September 2013.

About Vipidia (alogliptin)

About Vipdomet (alogliptin and metformin) fixed dose combination

Alogliptin and metformin is a FDC therapy for the treatment of Type 2 diabetes, which combines 12.5 mg alogliptin and 1000 mg metformin in a single tablet, taken twice daily.⁴ Vipdomet is indicated in the treatment of adult patients aged 18 years and older with Type 2 diabetes mellitus:

About Incresync (alogliptin and pioglitazone) fixed dose combination

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.⁵ Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with Type 2 diabetes mellitus:

About Type 2 diabetes

*Based on conversion of USD 147 billion,¹ where 1 EUR = 1.36035 USD as of 10 July 2014

About Takeda Pharmaceuticals International GmbH

Headquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the Company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus include cardiovascular and metabolic, oncology, respiratory and immunology, central nervous system, general medicine, and vaccines.

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. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

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

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, the more recent developments of alogliptin and the fixed-dose combinations (FDC) alogliptin and pioglitazone, and alogliptin and metformin HCl. The company's strong, diverse diabetes portfolio and available medications mark important milestones in Takeda's ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

References

¹ International Diabetes Federation. IDF Atlas, sixth edition. Last accessed July 10, 2014. Available at: http://www.idf.org/diabetesatlas.

² European Medicines Agency. Available at: http://www.ema.europa.eu/ema/.

³ Vipidia Summary of Product Characteristics. Last accessed July 10, 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002182/WC500152271.pdf.

⁴ Vipdomet Summary of Product Characteristics. Last accessed July 10, 2014, available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002654/WC500152141.pdf.

⁵ Incresync Summary of Product Characteristics. Last accessed July 10, 2014, available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002178/WC500152197.pdf.

⁶ International Diabetes Federation. Diabetes: Facts and figures. Last accessed July 10, 2014. Available at: http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures.

⁷ Inzucchi SE, Bergenstal RM et al. Management of Hyperglycaemia in Type 2 Diabetes: A Patient-Centred Approach. Diabetes Care. 2012:35: (6):1364-1379.