08.05.2008 12:40:00
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GATTEX(TM) Abstracts Accepted for Presentation at DDW Conference; Phase 3 Short Bowel Syndrome Results Scheduled for Oral Plenary Session
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced that three
abstracts related to the company’s development
program for GATTEX™ (teduglutide) for
intestinal failure associated with short bowel syndrome (SBS) were
accepted for presentation at the 2008 Digestive Disease Week (DDW)
conference in San Diego May 17-22, 2008. The results from a Phase 3
study of GATTEX for SBS patients who are dependent upon parenteral
nutrition will be presented in an American Gastroenterological
Association (AGA) Institute clinical science plenary session. A second
oral presentation will review improvements in fluid balance in the Phase
3 SBS study in an AGA Institute SBS research forum. The date, time, and
location for the two oral sessions, as well as for a poster presentation
are listed below.
Francois Nader, M.D., president and chief executive officer stated: "The
acceptance of the GATTEX abstracts for presentation at DDW demonstrate
the importance of finding new treatments for patients with intestinal
failure who have limited treatment options. We are particularly pleased
that our Phase 3 study evaluating GATTEX for short bowel syndrome will
be presented at an AGA clinical science plenary session. Short bowel
syndrome can be a highly debilitating condition and the results of our
Phase 3 study suggest that GATTEX has the potential to be a major
treatment advance for this orphan indication.”
The abstracts accepted for presentation are summarized as follows:
Session:
AGA Institute: Clinical Science Plenary
Abstract title: 212:
"Teduglutide, a Novel GLP-2 Analog, in the Management of Short Bowel
Syndrome (SBS) Patients Dependent On Parenteral Nutrition: a
Multicenter, Multinational Placebo-Controlled Clinical Trial" by
Stephen J O'Keefe, Richard Gilroy, Palle B Jeppesen, Bernard
Messing, Johane P Allard, Douglas L Seidner, Marek Pertkiewicz,
Roxanne Kapikian, Nancy McGraw, John Caminis.
Type:
Plenary Session
Date/Time:
5/19/2008 8:00 AM - 10:00 AM
Location:
Room 20BCD San Diego Convention Center
Session:
AGA Institute Short Bowel Syndrome
Abstract title: 757:
"Teduglutide, a Glucagon-Like Peptide-2 (GLP-2) Analog, Improves
Fluid Balance in Short Bowel Syndrome (SBS) Patients Depending On
Parenteral Support (PN)" by Palle B Jeppesen, Bernard Messing, Marek
Pertkiewicz, Jane Cyran, Lidia L Demchyshyn, Ronald Kershner
Type:
Research Forum
Date/Time:
5/20/2008 2:15 PM - 3:45 PM
Location:
Room 30D San Diego Convention Center
Session:
AGA Institute: Novel Diagnostics and Therapeutics in Intestinal
Disease
Abstract title:
W1291: "Plasma citrulline acts as a biological marker of
intestinal adaptation in a monkey model of short bowel syndrome"
by Lidia L. Demchyshyn, Kerri L. Trendler, Clynn Wilker.
Type:
Poster Session
Date/Time:
5/21/2008 8:00 AM - 5:00 PM
Location:
Sails Pavilion San Diego Convention Center
The DDW program and abstracts are available online at the DDW website
and can be accessed at http://www.ddw.org
by clicking on the "accepted abstracts”
link, creating a MyDDW account, and searching for teduglutide or the
abstract author. Accepted abstracts will also be published in the
supplements to the April issues of either Gastroenterology or GIE:
Gastrointestinal Endoscopy.
About DDW
DDW is the largest international gathering of physicians, researchers
and academics in the fields of gastroenterology, hepatology, endoscopy
and gastrointestinal surgery. Jointly sponsored by the American
Association for the Study of Liver Diseases, the American
Gastroenterological Association (AGA) Institute, the American Society
for Gastrointestinal Endoscopy and the Society for Surgery of the
Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego
Convention Center, San Diego, CA. The meeting showcases approximately
5,000 abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. For more information, visit www.ddw.org.
About Short Bowel Syndrome (SBS)
SBS is a highly disabling condition that impairs quality of life and can
lead to serious life-threatening complications. SBS typically arises
after extensive resection of the small bowel. There are an estimated
10,000 to 15,000 SBS patients in North America who are PN-dependent, the
cost of which can exceed $100,000 annually per patient. SBS patients
suffer from malnutrition, severe diarrhea, dehydration, fatigue,
osteopenia, and weight loss due to a loss in the ability to absorb
adequate amounts of nutrients and water. The goals of current treatment
are to maintain fluid electrolyte, and nutrient balances through dietary
management, including the use of PN. 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™
GATTEX (teduglutide) is a proprietary analog of human glucagon-like
peptide 2 that stimulates the repair and regeneration of cells lining
the small intestine. GATTEX is in Phase 3 clinical development to reduce
dependence on parenteral nutrition (PN) in patients with short bowel
syndrome (SBS). NPS has reported positive findings from recently
completed studies in which GATTEX demonstrated a favorable safety
profile and significant reductions in mean PN volume from pretreatment
baseline were observed. NPS is also advancing preclinical studies to
evaluate teduglutide as a possible treatment for gastrointestinal
mucositis, a complication of certain cancer treatments, and necrotizing
enterocolitis, a serious gastrointestinal disorder that primarily
affects premature infants.
About NPS Pharmaceuticals
NPS Pharmaceuticals is developing specialty therapeutics for
gastrointestinal and endocrine disorders with high unmet medical need.
The company is currently advancing two late-stage programs. Teduglutide,
a proprietary analog of GLP-2, is in Phase 3 clinical development for
intestinal failure associated with short bowel syndrome as GATTEX™
and in preclinical development for gastrointestinal mucositis and
necrotizing enterocolitis. NPSP558 (parathyroid hormone 1-84 [rDNA
origin] injection) is in Phase 2 clinical
development as a hormone therapy for hypoparathyroidism. NPS complements
its proprietary programs with a royalty-based portfolio of products and
product candidates that includes strategic partnerships with Amgen,
GlaxoSmithKline, Janssen, Kirin, and Nycomed. Additional information is
available at 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 not successfully
executing its preclinical and clinical studies with respect to GATTEX
and not gaining marketing 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.
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