NPS Reports Successful GATTEX(TM) Exten...( Top-Line Data Confirm...),Health

Top-Line Data Confirm Pivotal Study Findings

BEDMINSTER, N.J., March 17 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today reported positive top-line results from a 28-week blinded Phase 3-extension study of GATTEX(TM) (teduglutide) for short bowel syndrome (SBS) patients who are dependent upon parenteral nutrition (PN). The extension study enrolled 65 of the 71 patients (91%) who had completed a 24-week randomized Phase 3 study that evaluated low-dose GATTEX (0.05 mg/kg/day) and high-dose GATTEX (0.10 mg/kg/day) versus placebo.

The primary objective of the Phase 3 extension study was to evaluate the long-term safety and tolerability of daily GATTEX dosing for up to 52 weeks (24-week Phase 3 study and 28-week extension study). Overall, both doses of GATTEX were safe and generally well-tolerated, with no statistical differences in the incidence rate of adverse events or serious adverse events among the treatment groups when compared to placebo-treated patients in the Phase 3 study, with the exception of injection site reactions, which were higher in the high-dose GATTEX dose. A number of efficacy measures were also included as a secondary endpoint of the extension study. The company expects full results from the Phase 3-extension study to be presented at a future medical meeting.

Key efficacy findings included:

-- Sixty-eight percent (68%) of the 25 patients who had received low-dose

GATTEX therapy and continued on low-dose GATTEX, and fifty-two percent

(52%) of the 27 patients who had received high-dose GATTEX therapy and

continued on high-dose GATTEX achieved a 20% or greater reduction in PN

after a total of 52 weeks of therapy.