Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


NPS Gattex Launch Preparations Focus On Clinical Care Coordinators

This article was originally published in The Pink Sheet Daily

Executive Summary

The rare-disease focused company is putting commercial plans in place for its first drug, Gattex, which could launch early next year, and is preparing to file a second NDA in mid-2013, later than expected due to requirements from FDA.

You may also be interested in...

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.

NPS Pharmaceuticals Stages A Second Act

Five years ago, NPS Pharmaceuticals received an FDA "approvable" letter for its osteoporosis candidate Preos (parathyroid hormone), a regulatory action that sent the company into a tailspin of cost cuts and downsizing. Now the Parsippany, NJ-based specialty pharma is gearing up for a second shot at the commercial market. Unlike in 2006, when NPS was focused on therapies for big primary care indications, however, the company believes success will come from a focus on niche gastrointestinal and endocrine disorders.


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts