NPS Pharmaceuticals (NASDAQ: NPSP) finally scored today with its first FDA drug approval since its founding 26 years ago. The agency said it approved teduglutide (Gattex) for adults with short bowel syndrome who do not receive enough nutrition from intravenous feeding, which is standard treatment for this rare and often fatal disease.
The approval wasn’t a surprise for the Bedminster, NJ-based company, given that the drug won a unanimous vote of support from an FDA panel of outside advisors in October. The company’s stock inched down by 14 cents cents, to $8.93, by midafternoon today.
Short bowel syndrome occurs after the partial or complete surgical removal of the intestine, usually as a result of trauma, cancer, or Crohn’s disease. It affects about 10,000 people in the U.S., and most of them must be fed intravenously for up to 10-12 hours a day. Teduglutide is an injection administered once a day that helps to rehabilitate the intestinal lining so that patients can eat food normally, reducing or even eliminating the need for intravenous feeding,
NPS went through a radical restructuring six years ago when Xconomist Francois Nader arrived as CEO, turning it from a fully integrated pharmaceutical company developing drugs for osteoporosis to a virtual company with a focus on rare diseases. The company has been surviving all this time on the royalties from four drugs it licensed to other companies in the 1990s. Those royalties brought in a total of $96.5 million last year.
The company plans to market teduglutide on its own in the U.S. and shares the rights to the drug overseas with Japan’s Takeda Pharmaceutical. NPS issued a statement saying it will hold a conference call to discuss its commercialization plans, and the cost of the therapy, on January 2.