NPS Pharmaceuticals (NPSP) received encouraging news when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of the company’s hormone replacement therapy Natpara (rhPTH [1-84]).

NPS Pharma’s candidate was recommended for long-term use to treat patients suffering from hypoparathyroidism, a rare disease caused by the deficiency/absence of parathyroid hormone, by 8 of the 13 panel members. The positive opinion rendered by the panel was widely expected following the upbeat briefing materials released by the FDA prior to the panel meeting Shoots Up Ahead of FDA Panel).

The favorable panel opinion was based on encouraging data from one pharmacology study in addition to four efficacy and safety studies on Natpara. The pivotal phase III randomized, double-blind, placebo controlled study (REPLACE) was the largest clinical trial conducted on hypoparathyroidism patients so far. The FDA panel’s positive opinion brightens the chances of Natpara gaining FDA approval next month (target date: Oct 24). The candidate enjoys orphan drug status in the U.S. as well as in the EU.

We expect investor focus to remain on its regulatory status. Natpara approval will augment the company’s top line and reduce its dependence on Gattex, currently NPS Pharma’s sole marketed product. Focus will also remain on the development of NPSP795 (autosomal dominant hypocalcemia: phase IIa).

NPS Pharma carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Gilead Sciences (GILD), Mallinckrodt (MNK) and Allergan (AGN). All three stocks sport a Zacks Rank #1 (Strong Buy).

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