NPS Pharmaceuticals Provides Update on GATTEX(TM) Clinical Development in Short Bowel Syndrome



    BEDMINSTER, N.J., Jan. 28 /CNW/ -- NPS Pharmaceuticals, Inc. (Nasdaq:  
NPSP) today announced it expects to begin a confirmatory Phase 3 clinical
study to evaluate GATTEX(TM) (teduglutide, recombinant GLP-2) in patients with
short bowel syndrome (SBS) who are dependent on parenteral nutrition (PN).  At
a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss
the regulatory requirements for the development of GATTEX for SBS, the FDA
recommended that NPS conduct a confirmatory Phase 3 study prior to submitting
a new drug application.  NPS is finalizing a protocol for the confirmatory
Phase 3 study to address the FDA's comments and incorporate results from the
ongoing Phase 3 extension study that will be available later this quarter.
    Tony Coles, M.D., president and chief executive officer of NPS, stated:
"We expect GATTEX to be a first-in-class therapy with the potential to create
a new standard of care for patients suffering from short bowel syndrome and we
greatly appreciate the FDA's guidance as we work to complete the drug's
development for this indication.  We look forward to concluding our
discussions with the agency, as well as, working with our partner Nycomed to
finalize the protocol for this confirmatory study.  NPS expects to begin
patient enrollment in the third quarter of this year."
    NPS expects the confirmatory study to be a placebo-controlled,
multi-center study for the evaluation of GATTEX versus placebo in patients
with PN-dependent SBS with an initial PN optimization and stabilization period
followed by a dosing period of 24 weeks.
    The Phase 3-extension study currently underway is evaluating GATTEX for
PN-dependent SBS patients.  Sixty-five patients (91%) who completed the
pivotal Phase 3 study elected to enroll in the 28-week extension study.
Patients already on GATTEX in the pivotal Phase 3 study continued to receive
the dose to which they were randomized.  Patients who received placebo in the
earlier pivotal study were randomized to receive either a low dose of GATTEX
(0.05 mg/kg/day) or a high dose of GATTEX (0.10 mg/kg/day).
    
    Phase 3 Results
    
    In October 2007, NPS reported positive top-line results from the
company's Phase 3 study of GATTEX in which 83 patients with short bowel
syndrome (SBS) received either a low dose of GATTEX, (0.05
milligrams/kilogram/day), a higher dose (0.10 mg/kg/day) or placebo.  The
clinical efficacy endpoint of the study was a reduction in PN of at least 20%
comparing baseline to weeks 16 to 24, measured as a graded response to capture
reductions up to 100%. In an intent-to-treat analysis, forty-six percent (46%)
of patients receiving the lower dose of GATTEX (N=35) responded and achieved a
highly statistically significant reduction in PN compared to placebo
(p=0.007).  Twenty-five percent (25%) of patients receiving the higher dose of
GATTEX (N=32) responded and showed a trend in the difference between the
treatment group and placebo, but this did not reach statistical significance
(p=0.161).  Two low-dose patients gained independence from and discontinued PN
by week 16 and a third high-dose patient discontinued PN at the end of
treatment.  The study's criteria for conducting the statistical analysis of
the primary endpoint required that the results for the high-dose group show
statistical significance before the results of the low-dose group could be
considered. Given the drug's orphan designation in SBS and the statistically
strong (p=0.007) and clinically meaningful findings in the low-dose group, the
company met with the FDA to discuss the regulatory pathway for GATTEX.
    
    About Short Bowel Syndrome (SBS)
    
    SBS is a condition resulting from the surgical removal of significant
portions of the bowel following injury or illness.  There are 16,000 to 20,000
adult patients with SBS in the United States.  Regulatory authorities in the
U.S. and European Union have granted orphan drug status to teduglutide for its
potential use, if approved, in treating SBS.  Symptoms of SBS include
diarrhea, dehydration, malnourishment, and weight loss caused by an inadequate
absorption of nutrients and fluids from the diet.  Long-term complications of
the condition may include an increased risk of systemic infections due to the
presence of an intravenous feeding line, degenerative changes in the bones and
nerves due to vitamin and mineral deficiencies, and liver failure.  Potential
benefits derived from reduced dependence on intravenous feeding may include
improved nutrition, lower rates of infections, and improved quality of life
due to more time away from intravenous feeding, which may provide greater
mobility and improved sleep.  More information about SBS is available on the
website, http://www.shortbowel.com and http://www.glucagon.com.
    
    About GATTEX(TM)
    
    A potential first-in-class drug, GATTEX is a proprietary analog of
naturally occurring human glucagon-like peptide 2 (GLP-2), a peptide secreted
primarily in the distal intestine and involved in the regeneration and repair
of the intestinal epithelium.  NPS is also pursuing development of GATTEX as a
possible treatment for chemotherapy-induced gastrointestinal mucositis in
cancer patients and necrotizing enterocolitis in preterm infants.
    
    About NPS Pharmaceuticals
    
    NPS Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of small molecules and recombinant proteins
as drugs, primarily for the treatment of metabolic, bone and mineral, and
central nervous system disorders.  The Company has drug candidates in various
stages of clinical development.  Additional information is available on the
NPS website, http://www.npsp.com.
    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 NPS's business include, but are not limited
to, the risk of obtaining the necessary regulatory approvals for GATTEX, as
well as other factors expressed in NPS'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.




For further information:

For further information: Susan Mesco of NPS Pharmaceuticals, Inc., 
+1-908-450-5516 Web Site: http://www.npsp.com                 
http://www.shortbowel.com                  http://www.glucagon.com

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NPS PHARMACEUTICALS, INC.

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