NPS drops 17% on Natpara vote
NPS Pharmaceuticals Inc. (NASDAQ:NPSP) lost $5.42 (17%) to $27.29 on Monday after FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of Natpara for hypoparathyroidism by an 8-5 vote Friday. Trading of NPS was halted on Friday.
In briefing documents released ahead of the meeting, FDA reviewers concluded that once-daily subcutaneous injections of Natpara reduced the need for calcium and vitamin D supplements. However, reviewers raised concerns about both hypocalcemia and hypercalcemia associated with Natpara's use, and noted that osteosarcoma rates in Natpara-treated rats were similar to those seen with Forteo teriparatide, a PTH fragment from Eli Lilly and Co. (NYSE:LLY) approved for osteoporosis that has a black-box warning about osteosarcoma risk and is not indicated for use beyond two years (see BioCentury Extra, Sept. 10). ...