PREOS(R) Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism



    PARSIPPANY, N.J., Sept. 19 /CNW/ -- NPS Pharmaceuticals, Inc. (Nasdaq:  
NPSP) announced today that the U.S. Food and Drug Administration's Office of
Orphan Products Development has granted orphan drug designation to PREOS(R)
(parathyroid hormone [rDNA origin] for injection) for the treatment of
hypoparathyroidism, a rare deficiency of parathyroid hormone for which there
is no FDA-approved therapy.
    Hypoparathyroidism afflicts approximately 65,000 people in the United
States and an estimated 120,000 outside of the U.S.  It is most often caused
by injury to or removal of the parathyroid glands during neck surgery. It also
occurs as an autoimmune disorder associated with HIV infection. Current
treatments include vitamin D analogs and large doses of supplemental calcium
to relieve the symptoms of neuromuscular irritability associated with
hypoparathyroidism. Despite these palliative therapies, the absence of
endogenous parathyroid hormone compromises the body's ability to properly
absorb calcium. This invariably results in hypercalciuria and
nephrocalcinosis, a serious condition characterized by calcium deposition in
the kidneys. PREOS could potentially be a first-in-class therapy for use in
this condition.
    "We greatly appreciate the FDA's support of our efforts to evaluate the
use of PREOS as a hormone replacement therapy to treat hypoparathyroidism. The
results of the proof-of-concept study using PREOS in this indication have been
very encouraging, especially when compared to current palliative therapies
that often result in long-term toxicities and complications for patients. We
are excited to expand the development of PREOS beyond our initial focus on
osteoporosis to include the drug's potential use as a treatment for
hypoparathyroidism," said Dr. Francois Nader, executive vice president and
chief operating officer of NPS.
    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
being marketed by Nycomed.
    Note: Statements made in this press release, which are not historical in
nature, constitute forward-looking statements for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and beliefs and are
subject to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the forward-looking
statements. All information in this press release is as of September 19, 2007
and we undertake no duty to update this information. A more complete
description of these risks can be found in our filings with the Securities and
Exchange Commission, including our Annual Report on Form 10-K for the
year-ended December 31, 2006 and our Quarterly Report on Form 10-Q for the
quarter-ended June 30, 2007.




For further information:

For further information: Brandi Simpson, +1-801-883-2397, or Gail
Brophy,  +1-973-658-8504, both of NPS Pharmaceuticals, Inc. Web Site:
http://www.npsp.com

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NPS PHARMACEUTICALS, INC.

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