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Clinical Benefits Demonstrated with Low-Dose GATTEX(TM) in Phase 3 Short Bowel Syndrome Study
Date:10/11/2007

sor of medicine and director of the Center for Intestinal Health & Nutrition Support, University of Pittsburgh Medical Center, said, "Judging from these top-line results, teduglutide is an exciting new treatment option for our patients with intestinal failure due to massive intestinal loss. We eagerly await the peer review and publication of the full results of this international, multi-center clinical trial to determine the specific indications for this new therapeutic advance."

In this Phase 3 study, there were no statistical differences in the incidence rates of adverse events or serious adverse events among the treatment groups when compared to placebo.

The study's Data Safety Monitoring Board (DSMB) found that GATTEX was generally well tolerated and demonstrated clinical benefits. Additionally, the DSMB supported the company's recommendation to continue the ongoing extension study. Ninety-two percent (92%) of the 71 patients who completed the Phase 3 trial enrolled in the extension study.

Dr. Tony Coles, president and CEO of NPS, stated: "The results of the study underline the importance of GATTEX as a potential new standard of care for SBS. We are particularly encouraged to see a reduction in PN over six months in patients with SBS who received the lower dose of GATTEX. Patients who responded to this dose were able to reduce their reliance on parenteral nutrition by over 20%, which represents a clinically meaningful benefit, and we are very excited that two of the 35 patients on the lower dose were able to eliminate their PN entirely by week 20, and a third patient was also able to stop PN altogether at week 24. We look forward to presenting these findings at an upcoming medical meeting and further exploring the full range of clinical benefits of GATTEX. We remain committed to making GATTEX available to patients as soon as possible and intend to meet with regulatory agencies to discuss next steps for regulatory approval. We also plan to conti
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SOURCE NPS Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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