FDA Accepts NPS Pharma's sNDA


NPS Pharmaceuticals, Inc. (NPSP) announced that the U.S. Food and Drug Administration (:FDA) has accepted its supplemental new drug application (sNDA) on Gattex for review. The company is looking to expand the label to include data from the 2 year phase III STEPS 2 extension study (n=88). The FDA’s decision regarding the label expansion should be out by Jun 28, 2014.

We note that Gattex, NPS Pharma’s sole marketed product, is available in the U.S. since Feb 2013 for treating adults with short bowel syndrome (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.

We note that Gattex has proved to be effective for long-term use according to data from the STEPS 2 study. Data from the study, presented by NPS Pharma, at the American College of gastroenterology annual scientific meeting and postgraduate course earlier in the year revealed that Gattex treatment resulted in additional, clinically meaningful reductions in the volume and days/week of parenteral support requirements. Moreover, long-term Gattex treatment did not result in any new unexpected safety issues.

NPS Pharma is also developing Natpara (rhPTH [1-84]) for the treatment of adult hypoparathyroidism. The company submitted a Biologic License Application to the FDA for the drug last month.

NPS Pharma carries a Zacks Rank #3 (Hold). Companies such as Actelion Ltd. (ALIOF), Jazz Pharmaceuticals (JAZZ) and AMAG Pharmaceuticals, Inc. (AMAG) currently look attractive. All 3 stocks carry a Zacks Rank #1 (Strong Buy).

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