BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported that three abstracts related to the Phase 3 REPLACE study of Natpara™ in hypoparathyroidism will be presented at ENDO 2012, the annual meeting of The Endocrine Society in Houston, TX, June 23-26, 2012.
In addition, NPS will webcast an analyst and investor briefing on Natpara beginning at 4:30 PM ET on Monday, June 25, 2012.
Dr. John P. Bilezikian, Professor of Medicine and Pharmacology at Columbia University and Principal Investigator of the company’s REPLACE study of Natpara, will discuss the data presented at ENDO 2012. The meeting will also include presentations by members of the company’s management on Natpara and hypoparathyroidism.
To access the live webcast, please visit the Calendar of Events page in the Investors section of the NPS website at http://www.npsp.com. A replay will be available approximately three hours after the event has concluded.
Natpara Presentations at ENDO 2012
Identified below are the abstract titles and presentation times.
Oral Presentation:
Abstract title: Efficacy of Recombinant Human Parathyroid Hormone (rhPTH
[1-84]) for the Treatment of Adults with Hypoparathyroidism: A
Randomized, Double-Blind, Placebo-Controlled Study
Lead author:
John Bilezikian, MD
Abstract Number: S18-3
Date: Saturday,
June 23, 2012
Session Information: Oral Session: Clinical Trial
Symposium (3:45 PM-5:15 PM)
Presentation Time: 4:15 PM
Poster Presentations:
Abstract title: Safety and Tolerability of Recombinant Human Parathyroid
Hormone (rhPTH [1-84]) in a Randomized, Double-Blind, Placebo-Controlled
Study for the Treatment of Adults with Hypoparathyroidism
Lead
author: Dolores Shoback, MD
Abstract Number: SUN-325
Date:
Sunday, June 24, 2012
Session Information: Poster Session:
Parathyroid Hormone Disorders
Presentation Time: 1:30 PM- 3:30 PM
Abstract title: A Randomized, Double-Blind, Placebo-Controlled Study to
Investigate Use of Recombinant Human Parathyroid Hormone (rhPTH [1-84])
for the Treatment of 134 Adults with Hypoparathyroidism: Baseline
Demographics and Subject Characteristics
Lead author: Michael
Mannstadt, MD
Abstract Number: SUN-341
Date: Sunday, June 24,
2012
Session Information: Poster Session: Parathyroid Hormone
Disorders
Presentation Time: 1:30 PM- 3:30 PM
The ENDO 2012 program and abstracts are available online and can be accessed at http://www.abstracts2view.com/endo/.
About Hypoparathyroidism
Hypoparathyroidism is a rare 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 physical and neurological symptoms, as well as bone impairments. There is no approved treatment for hypoparathyroidism. It is currently managed with large doses of oral calcium and active vitamin D supplementation to raise the calcium levels in the body 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.
The estimated U.S. prevalence of hypoparathyroidism is 80,000 to 100,000.
About Natpara™ (recombinant human parathyroid hormone 1-84 [rDNA origin] injection)
Natpara™ is a bioengineered replica of human parathyroid hormone 1-84 that is being developed as the first hormone replacement therapy for the underlying cause of hypoparathyroidism. NPS reported positive findings from a Phase 3 registration study, known as REPLACE, which met the primary efficacy endpoint with a statistically higher responder rate versus placebo. A responder was defined as a 50 percent or greater reduction in oral calcium supplementation and active vitamin D therapy and a total serum calcium concentration that was maintained compared to baseline.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a biopharmaceutical company focused on bringing orphan products to patients with rare disorders and few, if any, therapeutic options. NPS is advancing two late-stage registration programs. A New Drug Application is undergoing regulatory review for Gattex® (teduglutide) as a treatment for adult short bowel syndrome (SBS) and the company plans to submit a Biologic License Application for Natpara™ (recombinant human parathyroid hormone (rhPTH [1-84]) in adult hypoparathyroidism later this year. NPS’ 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, Kyowa Hakko Kirin, Nycomed (recently acquired by Takeda Pharmaceutical Company Limited), and Janssen Pharmaceuticals. Additional information about NPS is available through its corporate website, http://www.npsp.com.
“NPS,” “NPS Pharmaceuticals,” “Gattex,” and “Natpara” are the company’s trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.
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. Risks associated to the company’s business include, but are not limited to, the risks associated with any failure by the company to successfully complete its preclinical and clinical studies within the projected time frames or not at all, the risk of not gaining marketing approvals for Gattex and Natpara, the risks associated with the company’s strategy, 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.