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NPS Estimates Gattex Initial Market At $150 Million To $250 Million

This article was originally published in The Pink Sheet Daily

Executive Summary

Company is seeking a pre-NDA meeting with FDA to discuss mixed top-line results from a Phase III study of the agent in short bowel syndrome.

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NPS Pharma’s REMS For Gattex Will Face FDA Panel Scrutiny

In briefing documents released ahead of the Oct. 16 Gastrointestinal Drugs Advisory Committee review, FDA suggests there is room for improvement in NPS’ communication plan for the short bowel syndrome treatment teduglutide to convey serious risks about malignancy and polyp growth and GI obstruction.

Gattex Goes To Advisory Panel With Positive Confirmatory Trial Data

Clinical data for teduglutide, which goes before the Gastrointestinal Drugs Advisory Committee Oct. 16 as the first drug for treating short bowel syndrome, includes positive results from a confirmatory trial and mixed results from the initial study.

Swiss Pharma Nycomed Agrees To Market NPS’ Gattex Ex-U.S.

NPS gets $35 million upfront, potential $150 million in milestones and double-digit royalties from Nycomed for Gattex.

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