NPS Pharmaceuticals, Inc. (NPSP) announced that it has started a 12 week global registration study (n~36) on its sole marketed product Gattex (teduglutide) in pediatrics suffering from short bowel syndrome (SBS). The patients are dependent on parenteral support.
The open-label study will be conducted in the U.S. and Europe. NPS Pharma intends to present top-line data from the study in 2014/2015. The initiation of the study is a step by NPS Pharma towards making Gattex available for treating children with SBS.
Currently, Gattex is available in the U.S. (since Feb 2013) for treating adults with SBS, dependent on parenteral support. The drug was cleared in the EU in 2012 (European trade name: Revestive). The company expects to launch the drug in the EU in the first half of 2014.
The lead pipeline candidate at NPS Pharma is Natpara (rhPTH [1-84]) for the treatment of adult hypoparathyroidism. The company submitted a Biologic License Application to the U.S. Food and Drug Administration (FDA). European approval for Natpara in the same indication is expected to be sought during the course of 2014. Management at NPS Pharma is highly bullish on the prospects of the candidate.
Another interesting candidate in NPS Pharma’s pipeline is NPSP795 (autosomal dominant hypocalcemia). NPS Pharma intends to throw more light on the development of the candidate during the course of the year. The successful development and subsequent commercialization of the pipeline would reduce the company’s dependence on Gattex. We expect investor focus to remain on the company’s pipeline going forward.
NPS Pharma carries a Zacks Rank #3 (Hold). Better ranked stocks include Jazz Pharmaceuticals (JAZZ), Forest Laboratories Inc. (FRX) and WuXi PharmaTech (Cayman) Inc. (WX). All 3 stocks carry a Zacks Rank #1 (Strong Buy).
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment