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NPS Looks To Repeat Success At FDA AdCom With Second Orphan Drug

This article was originally published in The Pink Sheet Daily

Executive Summary

Endocrinoloigc and Metabolic Drugs Advisory Committee will weigh in on Natpara for hypoparathryodism Sept. 12.

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NPS Moves Toward Status As Global Orphan Drug Firm With Takeda Agreement

In a deal that moves a $50 million equity stake to Takeda, NPS reacquires ex-U.S. rights to teduglutide and PTH 1-84, enabling the New Jersey firm to position itself as a worldwide orphan drug specialist. Takeda also can earn a $30 million one-time, sales-dependent milestone under the deal.

With Gattex Approval, NPS Joins Pharma’s Commercial Ranks

NPS Pharmaceuticals will launch Gattex for the long-term treatment of short bowel syndrome, an ultra-orphan indication, with an ultra-orphan price tag to match: $295,000 per year.

FDA Panel Backs NPS Pharma’s Gattex But Questions Registry Plans

A post-approval registry for the short bowel syndrome drug needs to be rigorously designed and enroll a large proportion of patients in the orphan indication if it is to provide useful information about the drug’s long-term risks, members of FDA Gastrointestinal Drugs Advisory Committee said.


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