NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that it has established a patient-centric distribution and clinical service network for Gattex® (Teduglutide [rDNA origin]) for Injection, for subcutaneous use. The network is comprised of leading specialty home infusion providers, including Accredo Health Group, Inc.; BioScrip; Inc.; Coram, LLC; ThriveRx; and Walgreens Infusion Services. In addition to dispensing Gattex, the company’s contracted providers will provide clinical services to support the use of Gattex in reducing dependence on parenteral nutrition (PN) and intravenous fluids (IV) for patients with short bowel syndrome (SBS). Gattex was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2012 as a treatment for adults with SBS who are dependent on parenteral support. Gattex is the first-and-only FDA-approved therapy for the long-term treatment of SBS and the first major treatment advance for SBS in nearly 40 years.

By adding Gattex to their product offering the company’s contracted home infusion providers will offer a wide range of personalized services to PN-dependent patients with short bowel syndrome through an interdisciplinary team of experienced infusion professionals, including nurses, pharmacists, dietitians, and support professionals.

“The formation of this distribution and clinical care service network of key providers is critical in accelerating education and market access for Gattex,” commented Eric Pauwels, senior vice president and chief commercial officer of NPS Pharmaceuticals. “These relationships provide important strategic benefits as we leverage our contracted providers’ national and local presence to enhance clinical services and improve the medical outcomes of patients on Gattex, as well as expand our knowledge of key prescribers and patients more rapidly.”

About Short Bowel Syndrome

Short bowel syndrome (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 SBS is nutritional support, including parenteral nutrition (PN) and/or intravenous (IV) fluids to supplement and stabilize nutritional needs.

Although PN can provide nutritional support for SBS patients, it does not improve the body's own ability to absorb nutrients. PN is associated with serious complications, such as infections, blood clots or liver damage, and the risks increase the longer patients are on PN. Patients on PN often experience poor quality of life with difficulty sleeping, and frequent urination, and patients receiving chronic PN often experience a loss of independence.

Gattex Clinical Trials

NPS’ clinical development program for Gattex is the largest and most comprehensive conducted in SBS patients to date, consisting of 15 clinical studies. Across all clinical studies, 566 subjects were exposed to at least one dose of Gattex, of whom 134 had SBS and were treated with 0.05 mg/kg/day Gattex. The FDA’s approval of Gattex was based on an international, 24-week, double-blind, placebo-controlled, pivotal Phase 3 trial, known as STEPS. The primary endpoint of STEPS was defined as a 20 percent or greater PN/IV volume reduction demonstrated at week 20 and sustained at week 24. The study's secondary endpoints included reductions in PN/IV volume and additional days off therapy. Key findings from the STEPS trial include:

  • In an intent-to-treat analysis at weeks 20 and 24, 63 percent of patients treated with Gattex achieved at least a 20 percent reduction in weekly PN/IV volume when compared to baseline, versus 30 percent for placebo (p=0.002).
  • After 24 weeks of treatment, PN volume declined by 32 percent (4.4 L/wk) in Gattex-treated patients, versus 21 percent (2.3 L/wk) in the placebo group (p
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