Press Release
GATTEX(TM) Abstracts Accepted for Presentation at DDW Conference; Phase 3 Short Bowel Syndrome Results Scheduled for Oral Plenary Session
BEDMINSTER, N.J.--(BUSINESS WIRE)--May 8, 2008--NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced that three abstracts related to the company's development program for GATTEX(TM) (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(TM)
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(TM) 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.
CONTACT: NPS Pharmaceuticals, Inc.
Susan Mesco, 908-450-5516
SOURCE: NPS Pharmaceuticals, Inc.
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