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OSAKA, Japan

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it will feature 7 presentations, including one oral presentation, at the upcoming European Congress of Endocrinology (ECE) Annual Meeting from May 18-21, 2019 in Lyon, France. The data presentations include findings from new research into the long-term risks of cardiovascular, renal and infection complications that patients with chronic hypoparathyroidism may experience as well as the latest findings from on-going real world and clinical studies, including the Global Burden of Illness Survey and the 6-year RACE study.

Takeda will also sponsor two satellite symposia. The first will focus on the burden of illness in chronic hypoparathyroidism patients with impaired biochemical control and comorbidities associated with the disease (Forum 1 on May 19, 13.45–14.45). The second symposium will present new perspectives in managing not adequately controlled hypoparathyroidism patients (Forum 3 on May 20, 13.45–14.35). Takeda will also have an exhibition booth throughout the congress (Booth #B02).

“The new research we are presenting at ECE 2019 continues to further our understanding of chronic hypoparathyroidism, especially about how long-term complications and symptoms may impact patients living with this rare disease,” explained John Germak M.D., Global Medical Team Lead at Takeda. “The clinical and real-world studies reflect our commitment to advancing our knowledge of chronic hypoparathyroidism and to improving patient care,” he added.

Hypoparathyroidism is a rare endocrine disease that occurs when inadequate levels of parathyroid hormone (PTH) are secreted by the parathyroid glands, resulting in a mineral imbalance in the body expressed by a low concentration of calcium (hypocalcemia) and a high concentration of phosphate (hyperphosphatemia) in the blood.¹ Studies have shown that a range of approximately 24–37 in 100,000 patients are affected by hypoparathyroidism.² In patients who are not adequately controlled, this disease can have a significant impact on patient well-being through a range of physical, cognitive and emotional symptoms, and comorbidities.^3,4

Takeda’s presence at this year’s ECE meeting includes the following presentations, which are intended for scientific discussion only:

• Risk of sepsis, respiratory infections, and kidney or other genitourinary (GU) infections in patients with chronic hypoparathyroidism (HypoPT)⁴ OC1.4, May 19, 2019, Salle Gratte-Ciel 1+2+3, 12.00 – 13.00
• Risk of myocardial infarction, stroke and other cardiovascular conditions in patients with chronic hypoparathyroidism: A retrospective cohort⁵ GP148, May 20, 2019, Exhibition area, 13.00 – 14.00
• Risk of chronic kidney disease (CKD) and CKD progression in patients with chronic hypoparathyroidism (HypoPT)⁶ GP149, May 20, 2019, Exhibition area, 13.00 – 14.00
• Risk of nephrolithiasis and nephrocalcinosis in patients with chronic hypoparathyroidism (HypoPT)⁷ GP147, May 20, 2019, Exhibition area, 13.00 – 14.00
• Impact of chronic hypoparathyroidism on Health-Related Quality of Life: Findings from a 13-country patient survey⁸ GP25, May 19, 2019, Exhibition area, 13.00 – 14.00
• Risk of Type 2 diabetes (T2D) in patients with chronic hypoparathyroidism. (HypoPT)⁹ P1038, May 21, 2019, Exhibition area, 12.30 – 14.30
• Recombinant human parathyroid hormone 1-84 for the treatment of adults with chronic hypoparathyroidism: Six-year safety and efficacy results of the RACE study¹⁰ GP15, May 19, 2019, Exhibition area, 13.00 – 14.00

All abstracts will be available on the ECE website following the meeting.

About Hypoparathyroidism

Chronic hypoparathyroidism is diagnosed in patients with a low concentration of calcium in the blood and inappropriately low PTH levels; for postsurgical hypoparathyroidism, the features of hypoparathyroidism must persist for at least 6 months after surgery to be considered chronic.^11,12

About NATPAR^®▼(parathyroid hormone) for Injection in Europe

In Europe, the recombinant human parathyroid hormone 1-84 for treatment of adults with chronic HypoPT is approved under the tradename NATPAR^®. NATPAR is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.¹³ Takeda is authorised to market NATPAR in the 28 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. NATPAR is currently commercially available in Germany, Greece, Austria, Denmark and Norway.

Click here for the full European Product Information: https://www.ema.europa.eu/en/documents/product-information/natpar-epar-product-information_en.pdf

For US Full Prescribing Information, including approved indication and important safety information, please visit: http://www.shirecontent.com/PI/PDFs/Natpara_USA_ENG.pdf

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience, and Rare Diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com

References

1) Shoback D, Bilezikian JP, Costa AG, et al. Presentation of Hypoparathyroidism: Etiologies and Clinical Features. J Clin Endocrinol Metab. 2016;101(6):2300–12.

2) Abate EG and Clarke BL. Review of Hypoparathyroidism. Front. Endocrinol. 2016;7:172.

3) Hadker N, Egan J, Sanders J, et al. Understanding the burden of illness associated with hypoparathyroidism reported among patients in the PARADOX study. Endocr Pract. 2014;20(7):671–9.

4) Chen K, Kaul S, Curhan G, et al. Risk of sepsis, respiratory infections, and kidney or other genitourinary (GU) infections in patients with chronic hypoparathyroidism (HypoPT) Oral presentation [OC1.4].

5) Chen K, Kaul S, Curhan G, et al. Risk of Myocardial Infarction (MI), Stroke, and Other Cardiovascular (CV) Conditions in Patients with Chronic Hypoparathyroidism (HypoPT): A Retrospective Cohort Study.

6) Chen K, Gosmanova EO, Curhan G, et al. Risk of chronic kidney disease (CKD) and CKD progression in patients with chronic hypoparathyroidism (HypoPT).

7) Chen K, Curhan G, Gosmanova EO, et al. Risk of Nephrolithiasis and Nephrocalcinosis in Patients with Chronic Hypoparathyroidism (HypoPT): A Retrospective Cohort Study

8) Bollerslev J, Ennakhil NB, Chen K, et al. Impact of chronic hypoparathyroidism on Health-Related Quality of Life: Findings from a 13-country patient survey.

9) Chen K, Gosmanova EO, Curhan G, et al. Risk of Type 2 diabetes (T2D) in patients with chronic hypoparathyroidism. (HypoPT).

10) Bilezikian JP, Bone H, Clarke BL, et al. Recombinant human parathyroid hormone 1-84 for the treatment of adults with chronic hypoparathyroidism: Six-year safety and efficacy results of the RACE study.

11) Brandi ML, Bilezikian JP, Shoback D, et al. Management of Hypoparathyroidism: Summary Statement and Guidelines. J Clin Endocrinol Metab. 2016;101(6):2273–83.

12) Bollerslev J, Rejnmark L, Marcocci C, et al. European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults. Eur J Endocrinol. 2015;173:G1–G20.

13) Natpar^® Summary of Product Characteristics.

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