) announced that the label of its sole marketed product, Gattex,
has been updated by the FDA. The U.S. label of the drug now
includes long-term data from STEPS 2 (n=88) - the two-year
open-label extension of the 24-week phase III international STEPS
Gattex is available in the U.S. since Feb 2013 for treating adults
with short bowel syndrome, dependent on parenteral support. The
STEPS 2 study proved the effectiveness of Gattex for long-term use.
Data from the study revealed additional and clinically meaningful
reductions in the volume and days/week of parenteral support
requirements in patients who continued treatment with the drug
beyond two years. In addition, data from the extension study showed
that 13 patients achieved complete independence from parenteral
support. Moreover, long-term Gattex treatment did not result in any
new unexpected safety issues.
We remind investors that the FDA accepted NPS Pharma's marketing
application seeking to update Gattex's label in Nov 2013. The
favorable FDA decision should augment the drug's sales potential.
NPS Pharma expects to add another product - Natpara (rhPTH [1-84])
- to its portfolio later in the year. The company is looking to get
Natpara, which has been granted orphan drug status in the U.S. and
EU, approved for treating hypoparathyroidism. The candidate is
currently under review in the U.S. A decision from the FDA on
Natpara is expected by Oct 24, 2014. Approval of Natpara would
reduce the company's dependence on Gattex for growth.
NPS Pharma carries a Zacks Rank #5 (Strong Sell). Better-ranked
stocks in the healthcare sector include
The Medicines Company
). All three stocks sport a Zacks Rank #1 (Strong Buy).
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