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NPS Pharma’s 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. In keeping with its focus on Gattex, NPS Pharma announced data on the drug from two-year open-label extension study (STEPS II: n=88) in adults suffering from SBS. NPS Pharma also announced the submission of a supplemental new drug application to the FDA for revising Gattex’s label so as to include the long-term data from STEPS II.
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.
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 expects the drug to be approved in the U.S. before 2014 ends.
NPS Pharma carries a Zacks Rank #3 (Hold). Companies such as Actelion Ltd. ( ALIOF - Snapshot Report) , Jazz Pharmaceuticals Public Limited Company ( JAZZ - Analyst Report) and Bayer ( BAYRY - Analyst Report) currently look attractive. While Actelion carries a Zacks Rank #1 (Strong Buy), Jazz Pharma and Bayer are Zacks #2 Ranked (Buy) stocks.