NPS Pharmaceuticals Signs Agreements with Leading Specialty Home Infusion Providers to Support Distribution & Home-based Clin...
December 27 2012 - 8:00AM
Business Wire
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
Nps (NASDAQ:NPSP)
Historical Stock Chart
From Jul 2024 to Aug 2024
Nps (NASDAQ:NPSP)
Historical Stock Chart
From Aug 2023 to Aug 2024