PREOS(R) Granted U.S. Orphan Drug Status for Treatment of Hypopara...(ial use as atreatment for hypoparathyroi...),Health

Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually. Orphan drug designation entitles NPS to a seven-year period of marketing exclusivity in the United States for PREOS, if it is approved by the FDA for the treatment of hypoparathyroidism, and enables the company to apply for research funding, tax credits for certain research expenses, and a waiver from the FDA's application user fee.

About NPS

NPS Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has drug candidates in various stages of clinical development. Additional information is available on the company's website, http://www.npsp.com.

About PREOS

PREOS is recombinant human parathyroid hormone (PTH). NPS has studied PREOS in a number of clinical settings to document its safety and effects on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-center, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of PTH to reduce the risk of first and subsequent vertebral fractures in post-menopausal women.

In the TOP study, PREOS demonstrated a statistically significant reduction in the risk of new vertebral fractures in women with and without pre-existing osteoporosis-related fractures. Results from the TOP study have been the foundation of both the E.U. and the U.S. marketing authorization applications.

PREOS has been approved in Europe under the brand name Preotact and is bein
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