New clinical and real-life data in chronic hypoparathyroidism, to advance understanding of
this rare disease and improve patients’ lives
Zug, Switzerland – May 19, 2017 – 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 study1
- Disease profiles of chronic hypoparathyroidism patients from PARADIGHM™ natural history global registry2
- Psychometric evaluation of the newly developed hypoparathyroidism symptom diary3
Shire is dedicated to addressing challenges in chronic hypoparathyroidism, and will be sponsoring several symposia at the meeting:
- 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
For further information, please contact:
NOTES TO EDITORS
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.
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 operations;
- 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 approval;
- 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 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 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.
- 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.
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