GSK, NPS enter agreement to evaluate ronacaleret in new indications

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NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today reported that it has entered into a new agreement with GlaxoSmithKline (GSK), that terminates and replaces a prior collaborative research and license agreement between NPS and GSK from 1993, which focused on the discovery and development of small molecule antagonists of the calcium receptor that increase secretion of parathyroid hormone (calcilytics).

As part of the new agreement, GSK will assign to NPS the investigational new drug filings for two calcilytic compounds, SB-423557 and SB-423562 (NPSP790 and NPSP795). Both compounds have been evaluated in preclinical animal studies and Phase 1 human studies. NPS believes calcilytics may have clinical application in treating rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH).

The new agreement expands the licensed field of research for ronacaleret, which was discovered under the 1993 agreement and studied as a treatment for osteoporosis in post-menopausal women, to allow GSK to pursue stem cell transplants, in addition to osteoporosis and other bone disorders. GSK will be responsible for all development, manufacturing and commercialization of ronacaleret. NPS will be entitled to development milestones and royalties on any future sales of ronacaleret. GSK will no longer have rights to other calcilytic compounds discovered or developed under the 1993 agreement.

"We are pleased that GSK has decided to evaluate ronacaleret in new indications," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. "We are particularly excited about the prospects of assessing the potential of NPSP790 and NPSP795 in ADHH. This deal aligns with our commitment to develop orphan therapeutics in areas of high unmet medical need and is complementary to our late-stage pipeline, which already includes a Phase 3 compound in development for the rare endocrine disorder hypoparathyroidism."

Source: NPS Pharmaceuticals, Inc.

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