ZUG, Switzerland, May 19, 2017 /PRNewswire/ --
New clinical and real-life data
in chronic hypoparathyroidism, to advance
understanding of this rare disease and improve patients'
lives
Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare
diseases, announced today new research to be presented on
rhPTH(1-84) and on the treatment and management of chronic
hypoparathyroidism at the upcoming 19th Annual Meeting
of the European Congress of Endocrinology (ECE), 20-23 May,
Lisbon, Portugal. The data being
shared provides valuable new insights into chronic
hypoparathyroidism, including the long term treatment effect of
rhPTH(1-84),[1] extensive global
registry data on a number of disease related
variables,[2] and patient-reported
outcome (PRO) data on symptoms related to the disease from the
Hypoparathyroidism Symptom Diary
(HPT-SD).[3] These data
demonstrate Shire's long term commitment to improving our
understanding of this rare condition in order to further improve
the lives of people living with chronic hypoparathyroidism.
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.[4] Not adequately
controlled hypoparathyroidism has a significant impact on patient
well-being through physical, cognitive, and emotional
symptoms.[5],[6]
Chronic hypoparathyroidism is diagnosed in patients with a low
concentration of calcium in the blood and inappropriately low PTH
levels; for postsurgical chronic hypoparathyroidism, the features
of hypoparathyroidism must persist for at least 6 months after
surgery.[5],[7]
''Diseases like hypoparathyroidism are poorly understood because
they are rare and lack both clinical and real-life data. We are
absolutely committed to advancing the knowledge and understanding
of the science of chronic hypoparathyroidism, and of patients'
needs," said Dr John Germak, Global
Medical Lead, Internal Medicine. "At ECE we will share new,
important research about this rare condition with the scientific
community. These new data are an important step forward for Shire
to further our understanding of the disease so that we can continue
to pursue better outcomes for people living with chronic
hypoparathyroidism and other endocrine disorders."
At the congress, there will be three poster presentations on
chronic hypoparathyroidism and two satellite symposia. Abstracts
will be available on the ECE website at http://www.ece2017.org/
following the meeting.
- Recombinant human parathyroid hormone (rhPTH[1-84]): 3 year
analysis from RACE study[1]
Poster #GP47
- Disease profiles of chronic hypoparathyroidism patients from
PARADIGHM™ natural history global
registry[2]
Poster #EP291
- Psychometric evaluation of the newly
developed hypoparathyroidism symptom
diary[3]
Poster #EP1263
Shire is dedicated to addressing challenges in chronic
hypoparathyroidism, and will be sponsoring several symposia at the
meeting:
Shire-sponsored symposia
- Perspectives on chronic hypoparathyroidism - the
patient experience
Sunday 21st May, 14:00 - 15:15
- rhPTH(1-84) for patients with chronic
hypoparathyroidism
Monday 22nd May, 14:00 - 15:15
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on
serving people with rare diseases. We strive to develop
best-in-class products, many of which are available in more than
100 countries, across core therapeutic areas including Hematology,
Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders,
Gastrointestinal / Internal Medicine / Endocrine and Hereditary
Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to
develop and deliver breakthrough therapies for the hundreds of
millions of people in the world affected by rare diseases and other
high-need conditions, and who lack effective therapies to live
their lives to the fullest.
http://www.shire.com
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could be materially adversely affected. The risks and uncertainties
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things, significant delays, an increase in operating costs, lost
product sales, an interruption of research activities or the delay
of new product launches;
- certain of Shire's therapies involve lengthy and complex
processes, which may prevent Shire from timely responding to market
forces and effectively managing its production capacity;
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and development. The successful development of these products is
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and there is no guarantee that these products will receive
regulatory approval;
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to sell or market products profitably. Fluctuations in buying or
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and other intellectual property rights required for its business,
could have a material adverse effect on the Company's revenues,
financial condition or results of operations;
- inability to successfully compete for highly qualified
personnel from other companies and organizations;
- failure to achieve the strategic objectives, including expected
operating efficiencies, cost savings, revenue enhancements,
synergies or other benefits at the time anticipated or at all with
respect to Shire's acquisitions, including NPS Pharmaceuticals
Inc., Dyax Corp., or Baxalta Incorporated may adversely affect
Shire's financial condition and results of operations;
- Shire's growth strategy depends in part upon its ability to
expand its product portfolio through external collaborations,
which, if unsuccessful, may adversely affect the development and
sale of its products;
- a slowdown of global economic growth, or economic instability
of countries in which Shire does business, as well as changes in
foreign currency exchange rates and interest rates, that adversely
impact the availability and cost of credit and customer purchasing
and payment patterns, including the collectability of customer
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to Shire's reputation, the withdrawal of the product and legal
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highly regulated markets in which it operates may result in
significant legal costs and the payment of substantial compensation
or fines;
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and infrastructure face certain risks, including from service
disruptions, the loss of sensitive or confidential information,
cyber-attacks and other security breaches or data leakages that
could have a material adverse effect on Shire's revenues, financial
condition or results of operations;
- Shire incurred substantial additional indebtedness to finance
the Baxalta acquisition, which may decrease its business
flexibility and increase borrowing costs; and
- a further list and description of risks, uncertainties and
other matters can be found in Shire's most recent Annual Report on
Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-Q,
in each case including those risks outlined in "ITEM 1A: Risk
Factors", and in Shire's subsequent reports on Form 8-K and other
Securities and Exchange Commission filings, all of which are
available on Shire's website.
All forward-looking statements attributable to us or any person
acting on our behalf are expressly qualified in their entirety by
this cautionary statement. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date hereof. Except to the extent otherwise required by
applicable law, we do not undertake any obligation to update or
revise forward-looking statements, whether as a result of new
information, future events or otherwise.
References
- European Society of Endocrinology, May
2017. Available at
http://www.endocrine-abstracts.org/ea/0049/ea0049gp47.htm.
- European Society of Endocrinology, May
2017. Available at
http://www.endocrine-abstracts.org/ea/0049/ea0049ep291.htm.
- European Society of Endocrinology, May
2017. Available at
http://www.endocrine-abstracts.org/ea/0049/ea0049ep1263.htm.
- Shoback D. N Engl J Med. 2008;359:391-403.
- Bollerslev J, et al. Eur J Endocrinol. 2015;173:G1-G20.
- Hadker N, et al. Endocr Pract. 2014;20(7):671-9.
- Brandi ML, et al. J Clin Endocrinol Metab.
2016;101:2273-83.
©2017 Shire. All rights reserved.
SHIRE and the Shire Logo are registered trademarks of Shire
Pharmaceutical Holdings Ireland Limited or its affiliates.
For further information, please
contact:
Investor Relations
Ian Karp
ikarp@shire.com
+1-781-482-9018
Robert Coates
rcoates@shire.com
+44-1256-894874
Media
Annabel Cowper
annabel.cowper@shire.com
+41-44-878-6638
Debbi Ford
debbi.ford@shire.com
+1-617-949-9083
SOURCE Shire plc