NPS Pharmaceuticals, Inc.
) announced that its pipeline candidate Natpara (rhPTH [1-84])
has been granted orphan drug status in the EU. Conatus is
developing Natpara for the treatment of hypoparathyroidism. The
production of parathyroid hormone is not sufficient in patients
affected by this disorder. The hormone is a prime regulator of
mineral homeostasis in the human body.
The designation is granted by the European Commission to
candidates being developed to treat rare (affecting a maximum of
five in 10,000 people in the EU) life-threatening or chronically
debilitating diseases. The positive news from the EU affected the
company's shares positively.
Natpara also enjoys similar status in the U.S. The U.S. Food
and Drug Administration granted orphan status to the candidate in
2007. By virtue of this status, NPS Pharma is eligible for some
benefits in developing the candidate.
We note that NPS Pharma submitted a Biologic License
Application to the FDA in Oct 2013 for treating
hypoparathyroidism. 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
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. Successful development and subsequent
commercialization of the pipeline would reduce the company's
dependence on its sole marketed product Gattex (teduglutide). We
expect investor focus to remain on the company's pipeline going
We note that Gattex 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). SBS patients should be stable
following a period of intestinal adaptation post operation.
NPS Pharma expects to launch the drug in the EU in the
first half of 2014.
NPS Pharma carries a Zacks Rank #3 (Hold). Better ranked
Forest Laboratories Inc.
PharmaTech (Cayman) Inc.
). All 3 stocks carry a Zacks Rank #1 (Strong Buy).
FOREST LABS A (FRX): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
NPS PHARMA INC (NPSP): Free Stock Analysis
WUXI PHARMATECH (WX): Free Stock Analysis
To read this article on Zacks.com click here.