Businessweek

NPS Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on the development of orphan products for patients with rare gastrointestinal and endocrine disorders and high unmet medical needs. The company’s primary clinical programs involve two proprietary therapeutic peptides to restore or replace biological function: Gattex (planned brand name for teduglutide) and Natpara (planned brand name for recombinant human parathyroid hormone 1-84). The company also has two earlier stage calcilytic compounds, NPSP790 and NPSP795 with potential application in rare endocrine disorders, as well as a valuable royalty-based portfolio of marketed products and products in development. Proprietary Product Candidates Teduglutide: Teduglutide is its proprietary analog of naturally occurring human glucagon-like peptide 2 (GLP-2), a peptide secreted primarily in the distal intestine and involved in the regeneration and repair of the intestinal epithelium. The company is developing teduglutide for commercialization in North America and it has licensed to Nycomed the right to develop and commercialize it outside of North America. It has completed a Phase 3 registration study of Gattex for adult patients with short bowel syndrome (SBS) who are dependent on PN/IV fluids. The company has also completed a Phase 2a proof-of-concept clinical study with teduglutide in patients with Crohn's disease. Natpara: Natpara is its proprietary recombinant, full-length (1-84), human parathyroid hormone (PTH 1-84) that the company is developing in the U.S. as a potential treatment for hypoparathyroidism. In 2010, the company has completed a randomized, double-blind, dose-escalating, placebo-controlled Phase 3 registration study that investigated the use of Natpara for the treatment of adults with hypoparathyroidism at approximately 30 sites in North America and Europe. NPSP790 and NPSP795: In 2011, the company entered into a new agreement with GlaxoSmithKline (GSK). As part of the agreement, GSK assigned to the company the investigational new drug filings for two calcilytic compounds, NPSP790 and NPSP795. Both compounds have been evaluated in preclinical animal studies and Phase 1 human studies. Calcilytics may have clinical application in treating rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). Royalty-Based Products and Product Candidates The company complements its proprietary clinical programs with collaborative research, development or commercial agreements with Amgen, Inc., Janssen Pharmaceutical (Janssen), GSK, Kyowa Hakko Kirin, and Nycomed. Amgen, Inc. and Kyowa Hakko Kirin (Cinacalcet HCl): Cinacalcet HCl is a small molecule compound used in treating hyperparathyroidism in patients with chronic kidney disease on dialysis and hypercalcemia in patients with parathyroid cancer. Cinacalcet HCl is a calcimimetic compound that interacts with the calcium receptor on parathyroid cells and thereby decreases the production of parathyroid hormone in such cells. The company licensed cinacalcet HCl to Kyowa Hakko Kirin Pharma, a wholly-owned subsidiary of Kyowa Hakko Kirin Holdings, for the drug's development and commercial sale in China, Japan, North and South Korea, and Taiwan. It also licensed worldwide rights (with the exception of the previously licensed Asian territories) to Amgen, Inc. to develop and commercialize cinacalcet HCl for the treatment of hyperparathyroidism. Nycomed (Preotact (parathyroid hormone 1-84 (rDNA origin) injection)): The company has entered into a license agreement with Nycomed in which it granted Nycomed license to sell, market, and commercialize Preotact in all non-U.S. territories, excluding Japan and Israel. The company also granted Nycomed a non-exclusive license to manufacture and develop Preotact. Nycomed (Teduglutide, ex-North American Development): The company has signed a license agreement with Nycomed in which it granted Nycomed the right to develop and commercialize teduglutide outside of North America. Ronacaleret (751689): Ronacaleret (751689) is a calcilytic compound developed under a collaborative research and worldwide exclusive license agreement with GSK for the research, development and commercialization of calcium receptor active compounds for the treatment of osteoporosis and other bone metabolism disorders, excluding hyperparathyroidism. In August 2011, the company formed a new agreement with GSK that expanded the licensed field of research for ronacaleret. The new agreement allows GSK to pursue stem cell transplants, in addition to osteoporosis and other bone disorders. Other Royalty Agreements The company has an agreement with Janssen Pharmaceuticals, Inc. (Janssen) pertaining to certain of its patents. Under this agreement, Janssen is required to pay the company royalties on any product sales of tapentadol hydrochloride and other related compounds in all countries in which the company has patents whose claims cover such sales. The company has an agreement with Hoffman-La Roche Inc. and F. Hoffmann-La Roche Ltd. (Roche), under which it granted Roche a non-exclusive license (with the right to grant sublicenses) to develop, make, import, use for sale or sell products covered by patents relating to the modulation of NMDA receptor activity using glycine uptake antagonists. History NPS Pharmaceuticals, Inc. was founded in 1986.