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Phase 3 GATTEX results presented at DDW highlight potential new treatment in short bowel syndrome
Date:5/19/2008

San Diego, California, May 19, 2008 NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today reported the presentation of Phase 3 data at the annual Digestive Disease Week (DDW) Congress on GATTEX (teduglutide), a novel investigational compound that may reduce dependence upon parenteral nutrition (PN) in patients with intestinal failure associated with short bowel syndrome (SBS).

The Phase 3 study evaluated two doses of GATTEX versus placebo. Results indicate that GATTEX was generally well-tolerated and effective in reducing the PN requirements of SBS patients, with the lower dose findings showing statistical significance versus placebo. The company is finalizing a protocol for a Phase 3 confirmatory study, which it expects will begin in the third quarter of 2008. Stephen OKeefe, M.D., professor of medicine, University of Pittsburgh, presented the Phase 3 results today at an American Gastroenterological Association (AGA) Institute clinical science plenary session.

Data from this study show that GATTEX has the potential to reduce or eliminate the need for parenteral nutrition, thereby reducing the complications associated with PN therapy and improving quality of life for patients with intestinal failure due to surgical resection (SBS), said Dr. OKeefe. These latest findings provide further support for the development of GATTEX as a potential first-in-class compound to reduce the dependency of SBS patients on IV fluids and nutrition without adverse side effects.

The pivotal Phase 3 study evaluated 83 SBS patients who are dependent on PN. After a PN stabilization and optimization period, patients were randomized to receive low-dose of GATTEX (0.05 mg/kg/day), high-dose GATTEX (0.10 mg/kg/day) or placebo for 24 weeks. A clinically significant PN response was defined as a weekly reduction of PN requirements of more than 20% at dosing week 20 and maintained through dosing week 24.

Key findings were as follows:


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Contact: Stephen Bingham
609-514-5117
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Source:Eurekalert

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