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 four abstracts supporting the efficacy of GATTEX® (teduglutide) in patients with short bowel syndrome (SBS) were accepted for presentation at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in Washington, DC, October 28-November 2, 2011.
Identified below are the abstract titles and presentation times.
Oral Presentation:
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Abstract title: Teduglutide, A Novel Analog of Glucagon-like Peptide 2 (GLP-2), is Effective and Well Tolerated in Reducing Parenteral Support (PS) Volume in Short Bowel Syndrome-Intestinal Failure (SBS-IF) Subjects: Results From a 24-week, Placebo-Controlled Phase 3 Trial |
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Lead author: Stephen J. O’Keefe, MD, MSc, University of Pittsburgh |
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Simultaneous Plenary Session: Stomach/Small Bowel |
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Abstract number: 50 |
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Date: November 1, 2011; 2:45 pm to 2:55 pm |
Poster Presentations:
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Abstract title: The Fluid Composite Effect (FCE): A Clinically Important Surrogate Measure of Intestinal Absorption in Adult Subjects with Short Bowel Syndrome (SBS)-Intestinal Failure (IF) Dependent on Parenteral Support (PS) Being Treated with Teduglutide |
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Lead author: Palle B. Jeppesen, MD, Rigshospitalet, Copenhagen, Denmark |
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Abstract number: P109 |
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Date: October 30, 2011; 3:30 pm to 7:00 pm |
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Abstract title: Teduglutide (TED) for the Treatment of Short Bowel Syndrome-Intestinal Failure (SBS-IF) Subjects Yields Further Reductions in Parenteral Support (PS): An Interim Assessment of a 2-Year, Open-label, Phase 3 Trial (STEPS2) |
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Lead author: Lauren K. Schwartz, MD, The Mount Sinai Medical Center |
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Abstract number: P535 |
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Date: October 31, 2011; 10:30 am to 4:00 pm |
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Abstract title: Teduglutide, A Glucagon-like Peptide-2 (GLP-2) Analog, Enhances the Structure of the Small Intestinal Mucosa in Parenteral Support-dependent Short Bowel Syndrome-intestinal Failure (SBS-IF) Subjects without Inducing Dysplasia |
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Lead author: Kelly A. Tappenden, PhD, RD, University of Illinois at Urbana-Champaign |
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Abstract number: P949 |
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Date: November 1, 2011; 10:30 am to 4:00 pm |
The ACG 2011 program and abstracts are available online and can be accessed at http://www.eventscribe.com/2011/acg/index.asp by clicking on the Oral & Posters page and searching abstracts for the keyword “teduglutide.”
About GATTEX® (teduglutide)
GATTEX (teduglutide) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. The lead indication for GATTEX is treatment of adults with short bowel syndrome. NPS has reported findings from completed studies in which GATTEX was well tolerated and effectively reduced parenteral nutrition and intravenous fluid volume requirements in subjects with adult short bowel syndrome.
Teduglutide has received orphan drug designation for the treatment of SBS from the U.S. Food and Drug Administration and the European Medicines Agency.
In March 2011, Nycomed submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for clearance to market teduglutide (Revestive(R)) as a once-daily subcutaneous treatment for short bowel syndrome. In 2007, NPS granted Nycomed the rights to develop and commercialize teduglutide outside the United States, Canada and Mexico. NPS retains all rights to teduglutide in North America.
About Short Bowel Syndrome
Short bowel syndrome, or SBS, is a highly disabling condition that can impair a patient's quality-of-life and lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel due to Crohn's disease, ischemia or other conditions. SBS patients often suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to the reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment for short bowel syndrome is nutritional support, including parenteral nutrition or intravenous fluids (parenteral support) to supplement and stabilize nutritional needs.
Although parenteral support can meet basic nutrition and fluid requirements by delivering them intravenously, it does not improve the body's own ability to absorb nutrients. Parenteral support is also associated with serious complications, such as infections, blood clots or liver damage, and the risks increase the longer patients are on it. Patients on parenteral support often experience a poor quality-of-life with difficulty sleeping, frequent urination and loss of independence.
There are an estimated 10,000 to 15,000 SBS patients in the U.S. who are dependent on parenteral support, the direct cost of which can exceed $100,000 annually per patient.
About NPS Pharmaceuticals
NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, GATTEX® (teduglutide) in short bowel syndrome (SBS) and NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) in hypoparathyroidism. 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, and Ortho-McNeil Pharmaceutical.
“NPS”, “NPS Pharmaceuticals”, and “GATTEX” are the company’s registered trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.