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Takeda to Highlight New Research into the Long-term Complications of Chronic Hypoparathyroidism at the European Congress of Endocrinology 2019 Annual Meeting

May 15, 2019 Off By BusinessWire

– Seven presentations will be shared, including new data on
the risks of long-term cardiovascular, renal and infection
complications, underlining Takeda’s commitment to further understanding
of this rare disease

OSAKA, Japan–(BUSINESS WIRE)–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.¹Studies
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)⁶GP149, 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.