NPS Pharmaceuticals 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 study.
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 Regeneron Pharmaceuticals (REGN - Free Report) , Biogen Idec (BIIB - Free Report) and The Medicines Company (MDCO - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).