Gattex is NPS Pharma’s (NPSP) 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).
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 issues.
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 year end.
NPS Pharma carries a Zacks Rank #3 (Hold). Companies such as Actelion Ltd. (ALIOF), Alexion Pharmaceuticals, Inc. (ALXN) and Endo Health Solutions Inc. (ENDP) currently look attractive. All 3 stocks carry a Zacks Rank #1 (Strong Buy).