NPS Reports Three Teduglutide Abstracts Accepted for Presentation at Digestive Disease Week Conference

Update: Gattex (teduglutide) Now FDA Approved - December 21, 2012

BEDMINSTER, N.J.--(BUSINESS WIRE)--May 28, 2009 - NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today reported that three abstracts addressing sub-study data from the company's completed Phase 3 study of GATTEX™ (teduglutide) in patients with short bowel syndrome (SBS) were accepted for presentation at the 2009 Digestive Disease Week (DDW) conference. The DDW conference is being held from May 30 through June 4, 2009 at McCormick Place in Chicago, Illinois. The abstract titles and presentation times for two oral presentations and one poster presentation are summarized below.

Oral Presentations:
           
          Abstract 897: “Teduglutide, a Novel GLP-2 Analogue, Decreases Fecal Wet Weight, Sodium and Potassium Excretion in Short Bowel Syndrome (SBS) Patients Dependent on Parenteral Nutrition (PN)” by B. Jeppesen et al. will be presented on June 2, 2009 from 4:00 – 4:15 pm, Central Daylight Time.
           
          Abstract 898: “Citrulline: a Potential Predictor of Reductions in Parenteral Nutrition Achieved in Chronic Parenteral Nutrition Dependant Patients with Short Bowel Syndrome (SBS) Treated with Teduglutide” by R. Gilroy et al. will be presented on June 2, 2009 from 4:15 – 4:30 pm, Central Daylight Time.
           
Poster Session:
           
          Abstract T1281: “The Influence of Teduglutide, a Novel GLP-2 Analogue, on Energy Absorption in Short Bowel Syndrome (SBS) Patients Dependent on Parenteral Nutrition (PN)” by B. Jeppesen et al. will be presented on June 2, 2009 from 8:00 am – 5:00 pm, Central Daylight Time.

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 program page and accepted abstracts link, creating a MyDDW account, and searching for teduglutide or the abstract author. Accepted abstracts will be published in a supplement to either the May 2009 issue of GIE: Gastrointestinal Endoscopy (ASGE abstracts) or the May 2009 issue of Gastroenterology (AASLD, AGA Institute and SSAT abstracts).

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 bowel. There are an estimated 10,000 to 15,000 SBS patients in North America who are dependent on parenteral nutrition (PN), 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 an inability to absorb adequate amounts of nutrients, fluid, and electrolytes. The goals of current treatment are to maintain fluid, electrolytes 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 PN may include improved nutrition and hydration, lower rates of infections, and improved quality of life due to more time away from PN, which may provide greater mobility and improved sleep.

About GATTEX™ (teduglutide)

GATTEX (teduglutide) is a proprietary analog of human glucagon-like peptide 2 that stimulates the repair and regeneration of cells lining the 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 in additional intestinal failure related conditions.

Teduglutide has received orphan drug designation for the treatment of SBS from the U.S. Food and Drug Administration and the European Medicines Agency.

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 30 – June 4, 2009, at the McCormick Place, Chicago, IL. 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 NPS Pharmaceuticals

NPS Pharmaceuticals is developing new treatment options for patients with rare gastrointestinal and endocrine disorders. The company is currently conducting two Phase 3 registration studies. Teduglutide, a proprietary analog of GLP-2, is being evaluated as GATTEX™ in a Phase 3 registration study known as STEPS for intestinal failure associated with short bowel syndrome and in preclinical development for gastrointestinal mucositis and other pediatric indications. NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) is being evaluated in a Phase 3 registration study known as REPLACE as a hormone replacement therapy for hypoparathyroidism. NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Kirin, Nycomed, and Ortho-McNeil. Additional information is available at http://www.npsp.com.

“NPS” and “NPS Pharmaceuticals” are the company's registered trademarks. Preotact® is the company's registered trademark in the U.S. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.

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 the company's business include, but are not limited to, the risks associated with any failure by the company to successfully complete its preclinical and clinical studies within the projected time frames or not at all, the risk of not gaining marketing approvals for GATTEX and NPSP558, the risks associated with the company's strategy, the risks associated with the company's auction-rate securities, as well as other risk factors described in the company'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: Investors: NPS Pharmaceuticals, Inc. Susan M. Mesco, 908-450-5516 smesco@npsp.com or Media: WeissComm Partners Edie DeVine, 209-814-9564 edevine@wcpglobal.com

 

Posted: May 2009

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