NPS Pharmaceuticals is reducing its workforce and consolidating operations while continuing to advance two pipeline candidates - the osteoporosis agent Preos and the gastrointestinal treatment teduglutide -following a review of its financial situation.

"We have decided that the most prudent way for us to maximize the value of our pipeline is to focus our own critical work on high value specialty indications, manage the execution of this activity through contract research organizations and find partners for indications we can't afford ourselves," CEO Anthony Coles told investors during a year-end earnings call March 14.

The initiative will involve downsizing NPS' workforce from 196 to 35 employees and closing its facilities in Salt Lake City and Toronto to consolidate operations in New Jersey by year end, the exec said. The firm is headquartered in Parsippany, N.J.

The company will outsource all new drug development activities and will seek partners to support its Phase III programs. Its own funding will be used to pursue high-value specialty indications for Preos and teduglutide.

NPS is forging ahead with development of Preos (recombinant human parathyroid hormone) despite an announcement last year that it would be moving away from Preos after a March 2006 "approvable" letter (¹ Pharmaceutical Approvals Monthly June 2006, p. 8). The firm announced last June that it would discontinue U.S. commercialization activities for the drug.

In the approvable letter, FDA expressed concern over hypercalcemia observed in postmenopausal women.

NPS has now received final feedback from FDA on the trial design for Preos, which "gives us clear direction for completing the U.S. development of Preos in osteoporosis," Coles said during the call. The new Phase IIIb trial is designed to be a 12-month bone-mineral density bridging study evaluating the safety and efficacy of 100 micrograms of Preos daily, 100 mcg every other day and 75 mcg daily versus placebo.

However, due to the size and anticipated cost of the trial, Coles said NPS does not plan to move forward with the study until it finds a partner to offset the development expenses.

"This degree of clarity from the agency ... now gives us clarity around the path for regulatory approval and review for the compound. With this information we feel confident that we can approach partners ... about what's going to be required," he told investors.

NPS is already partnered on Preos in Europe with Nycomed, which launched the product under the brand name Preotact in the second half of 2006.

A Phase II proof-of-concept study is also underway evaluating Preos as a hormone supplement to treat hypoparathyroidism.

NPS is on track to submit an NDA for use of teduglutide in short bowel syndrome in 2008 after completing enrollment and randomization of 84 patients in a Phase III study in December, the company said. NPS plans to complete the study in the second half of 2007.

NPS is also studying the glucagon-like peptide 2 analog in Crohn's disease, enterocolitis associated with chemotherapy and necrotizing enterocolitis.

Chemotherapy-induced enterocolitis causes inflammation and ulceration of the mucus membranes lining the digestive tract; it is a common dose-limiting side effect of chemotherapy. Necrotizing enterocolitis is the most common gastrointestinal emergency in neonates.

"These are both important and underserved conditions which fit our strategy of focusing on high-value specialty indications," Chief Medical and Commercial Officer Francois Nader told investors. "They are also logical extensions of teduglutide's mechanism of action and our clinical work with teduglutide in SBS and Crohn's disease.

NPS narrowed its net loss to $112.7 million, from $169.7 million in 2005. The gain included $31.9 million in royalty revenue from Amgen on sales of Sensipar (cinacalcet) and $11 million in one-time fees from GlaxoSmithKline and Johnson & Johnson related to licensing. GSK and NPS have a deal for a new series of back-up calcilytic compounds, while J&J and NPS are partnered on patents related to delucemine.

- Tamra Sami (t.sami@elsevier.com)

NPS Seeks Development Partners For Preos And Teduglutide, Reduces Force

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