) sole marketed product. NPS Pharma launched Gattex in the U.S.
in Feb 2013, following approval by the U.S. Food and Drug
Administration (FDA) in Dec 2012. The drug was cleared 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).
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The company expects to launch the drug in the EU in the first
half of 2014. NPS Pharma expects peak sales of the drug to be
higher in international markets than in the U.S. While announcing
its second-quarter results in August this year, NPS Pharma stated
that it expects 2013 global sales of Gattex/Revestive in the
range of $25- $30 million. The company expects 275-325 patients
to be under the treatment of its SBS therapy by Dec 31, 2013.
Gattex has also proved to be effective for long-term use
according to the new data presented by NPS Pharma from the 2 year
phase III extension study (STEPS 2: n=88). Data presented at the
American College of Gastroenterology annual scientific meeting
and postgraduate course 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
Following the encouraging long-term data, NPS Pharma has
submitted a Supplemental New Drug Application to the U.S. Food
and Drug Administration (FDA) to amend Gattex's label to include
STEPS 2 data.
NPS Pharma is also developing Natpara (rhPTH [1-84]) for the
treatment of adult hypoparathyroidism. The company expects to
submit a Biologic License Application to the FDA for the drug by
NPS Pharma carries a Zacks Rank #3 (Hold). Companies such as
Alexion Pharmaceuticals, Inc.
Endo Health Solutions Inc.
) currently look attractive. All 3 stocks carry a Zacks Rank #1