NPS Pharmaceuticals to Present Data from Natpara™ REPLACE Study and PARADOX Study at ENDO 2013, The
NPS Pharmaceuticals to Present Data from Natpara™ REPLACE Study and PARADOX Study at ENDO 2013, The Endocrine Society's 95thAnnual Meeting
BEDMINSTER, N.J.--(BUSINESS WIRE)-- NPS Pharmaceuticals, Inc., a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today reported that two abstracts related to the Phase 3 REPLACE study of Natpara™ in hypoparathyroidism and one abstract related to PARADOX, a 374-patient epidemiology study that assessed the clinical, social, and economic implications of hypoparathyroidism will be presented at ENDO 2013, The Endocrine Society's 95th Annual Meeting in San Francisco, June 15-18, 2013.
Summarized below are the poster titles and presentation times.
Abstract Title: The Effect of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) on Vitamin D Metabolism: Results from Phase III REPLACE and Phase I Clinical Studies
Presenter: Dolores M Shoback, MD
Abstract Number: SUN-234
Date: Sunday, June 16, 2013
Session Information: Bone & Calcium Metabolism: Clinical Trials & Case Series
Presentation Time: 1:45 PM - 3:45 PM
Abstract Title: The Effect of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) on Phosphate Homeostasis in Patients with Hypoparathyroidism
Presenter: Bart Clarke, MD, Mayo Clinic Rochester, Rochester, MN
Abstract Number: SUN-246
Date: Sunday, June 16, 2013
Session: Bone & Calcium Metabolism: Clinical Trials & Case Series
Presentation Time: 1:45 PM-3:45 PM
Abstract Title: Clinical Symptoms and Morbidities Reported among Patients with Hypoparathyroidism: Patients' Attitudes and Responses About hypoparathyroiDism tOleration eXplored (PARADOX Study)
Presenter: Bart Clarke, MD, Mayo Clinic Rochester, Rochester, MN
Abstract Number: SUN-249
Date: Sunday, June 16, 2013
Session: Bone & Calcium Metabolism: Clinical Trials & Case Series
Presentation Time: 1:45 PM-3:45 PM
The ENDO abstracts are available online at the conference website at https://endo.confex.com/endo/2013endo/webprogram/COP.html.
About Hypoparathyroidism
Hypoparathyroidism is a rare endocrine disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus. When the body has too little parathyroid hormone, blood calcium levels drop and phosphorus levels increase, which can cause a number of physical and mental symptoms, including uncontrollable muscle spasms and cramps, tetany, seizures, fatigue, anxiety, and depression. There is currently no FDA-approved replacement therapy for hypoparathyroidism, which is currently managed with large doses of calcium supplementation and active vitamin D therapy to raise the calcium levels in the blood and reduce the severity of symptoms. Over time, calcium may build up in the body and result in serious health risks, including calcifications in the kidneys, heart or brain. Hypoparathyroidism is believed to affect as many as 100,000 Americans.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide. The company's lead product, Gattex® (teduglutide [rDNA origin]) for injection (Revestive® (EU)) is approved in the U.S. for adult Short Bowel Syndrome (SBS) patients who are dependent on parenteral support. NPS is also developing Natpara® (rhPTH[1-84]) for the treatment of adult hypoparathyroidism and, subject to the resolution of certain manufacturing issues, expects to submit its Biologic License Application (BLA) to the FDA in 2013.
NPS's earlier stage pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Janssen Pharmaceuticals and Kyowa Hakko Kirin. Additional information about NPS is available through its corporate website, http://www.npsp.com.
"NPS," "NPS Pharmaceuticals," "Gattex," "Natpara", "Preotact", and "Revestive" are the company's trademarks.
Disclosure notice
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward looking statements include, but are not limited to, statements concerning the company's future financial performance. Risks associated to the company's business include, but are not limited to, the risks associated with any failure by the company to successfully commercialize Gattex (teduglutide [rDNA origin])for injection, including the risk that physicians and patients may not see the advantages of Gattex and may therefore be reluctant to utilize the product, the risk that private and public payers may be reluctant to cover or provide reimbursement for Gattex, the risk that the company may be unable to resolve the manufacturing issue in order to submit its BLA for Natpara, the risks associated with the company's strategy, global macroeconomic conditions, the impact of changes in management or staff levels, the effect of legislation effecting healthcare reform in the United States, as well as other risk factors described in the company's periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information, whether as a result of new information, future events or otherwise.
NPS Pharmaceuticals, Inc.
Susan M. Mesco
(908) 450-5516
smesco@npsp.com
KEYWORDS: United States North America California New Jersey
INDUSTRY KEYWORDS:
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