Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of investigational new drug applications and marketing applications, acceptance of these applications for review by regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Late last week, good news came NPS Pharmaceuticals, Inc.’s way (NPSP) with the FDA approving Natpara (EU trade name: Natpar) as an adjunct to calcium and vitamin D to control hypocalcemia in patients suffering from hypoparathyroidism (caused by the deficiency of parathyroid hormone/PTH). This makes Natpara the first and only bioengineered replica of human PTH to be approved by the FDA for this indication.
FDA approval was largely expected as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) had issued a favorable opinion in Sep 2014.
However, Natpara’s approval in the U.S. comes with a boxed warning regarding the potential risk of osteosarcoma (bone cancer). This warning was also anticipated at the EMDAC discussions held during the September meeting. The drug will be available under a Risk Evaluation and Mitigation Strategy.
We note that Natpara is currently under review in the EU for the same indication. Natpara enjoys orphan drug status both in the U.S. and EU.
Meanwhile, NPS Pharma is set to be acquired by Shire (SHPG) for $46 per share or approximately $5.2 billion (read more: Shire to Acquire NPS Pharmaceuticals for $5.2B). Shire stated in its press release that following the closure of the acquisition in the first quarter of 2015, Natpara will be launched in the U.S. in the second quarter.
NPS Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Endo International plc (ENDP) and Biodel Inc. (BIOD). Both carry a Zacks Rank #1 (Strong Buy).
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