NPS Pharmaceuticals, Inc.
) 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.
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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
AMAG Pharmaceuticals, Inc.
) currently look attractive. All 3 stocks carry a Zacks Rank #1