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2012 FDA Submission to Follow Pivotal Trial Findings

NPS Pharmaceuticals Seeks Bounce from Natpara Phase III

By Marie Powers
Staff Writer

Tuesday, November 8, 2011

One week after shares of NPS Pharmaceuticals Inc. were drubbed over safety concerns about the GLP-2 analogue Gattex (teduglutide) in short bowel syndrome, the company sought a ray of sunshine with positive top-line results from its pivotal Phase III REPLACE study of Natpara (NPSP558), a bioengineered replica of human parathyroid hormone (rhPTH 1-84), in adult hypoparathyroidism patients. (See BioWorld Today, Nov. 1, 2011.)

In an intent-to-treat analysis, NPS reported that 53 percent (48/90) of Natpara-treated patients achieved the primary endpoint vs.

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