Shire to Highlight New Research Into Chronic Hypoparathyroidism at the European Congress of Endocrinology

Geschrieben am 19-05-2017

Zug, Switzerland (ots/PRNewswire) -

New clinical and real-life data in chronic hypoparathyroidism, to
advance understanding of this rare disease and improve patients'

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 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(TM) 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

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


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.


Forward-Looking Statements

Statements included herein that are not historical facts,
including without limitation statements concerning future strategy,
plans, objectives, expectations and intentions, the anticipated
timing of clinical trials and approvals for, and the commercial
potential of, inline or pipeline products, are forward-looking
statements. Such forward-looking statements involve a number of risks
and uncertainties and are subject to change at any time. In the event
such risks or uncertainties materialize, Shire's results could be
materially adversely affected. The risks and uncertainties include,
but are not limited to, the following:

- Shire's products may not be a commercial success;
- increased pricing pressures and limits on patient access as a
result of governmental regulations and market developments may
affect Shire's future revenues, financial condition and results of
- Shire conducts its own manufacturing operations for certain of its
products and is reliant on third party contract manufacturers to
manufacture other products and to provide goods and services. Some
of Shire's products or ingredients are only available from a single
approved source for manufacture. Any disruption to the supply chain
for any of Shire's products may result in Shire being unable to
continue marketing or developing a product or may result in Shire
being unable to do so on a commercially viable basis for some
period of time;
- the manufacture of Shire's products is subject to extensive
oversight by various regulatory agencies. Regulatory approvals or
interventions associated with changes to manufacturing sites,
ingredients or manufacturing processes could lead to, among other
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;
- Shire has a portfolio of products in various stages of research and
development. The successful development of these products is highly
uncertain and requires significant expenditures and time, and there
is no guarantee that these products will receive regulatory
- the actions of certain customers could affect Shire's ability to
sell or market products profitably. Fluctuations in buying or
distribution patterns by such customers can adversely affect
Shire's revenues, financial conditions or results of operations;
- Shire's products and product candidates face substantial
competition in the product markets in which it operates, including
competition from generics;
- adverse outcomes in legal matters, tax audits and other disputes,
including Shire's ability to enforce and defend patents 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
- 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
accounts receivable;
- failure of a marketed product to work effectively or if such a
product is the cause of adverse side effects could result in damage
to Shire's reputation, the withdrawal of the product and legal
action against Shire;
- investigations or enforcement action by regulatory authorities or
law enforcement agencies relating to Shire's activities in the
highly regulated markets in which it operates may result in
significant legal costs and the payment of substantial compensation
or fines;
- Shire is dependent on information technology and its systems 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.


1. European Society of Endocrinology, May 2017. Available at
2. European Society of Endocrinology, May 2017. Available at
3. European Society of Endocrinology, May 2017. Available at
4. Shoback D. N Engl J Med. 2008;359:391-403.
5. Bollerslev J, et al. Eur J Endocrinol. 2015;173:G1-G20.
6. Hadker N, et al. Endocr Pract. 2014;20(7):671-9.
7. 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.

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de

, please contact:
Investor Relations
Ian Karp
Robert Coates
Annabel Cowper
Debbi Ford

Original-Content von: Shire Pharmaceuticals Group Plc, übermittelt durch news aktuell


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