NPS Pharmaceuticals to Present Data from Natpara™ REPLACE Study & PARADOX Study at ENDO 2013, The Endocrine Society’s 95t...
June 05 2013 - 7:11AM
Business Wire
NPS Pharmaceuticals, Inc., a biopharmaceutical company
pioneering and delivering therapies that transform the lives of
patients with rare diseases worldwide, today reported that two
abstracts related to the Phase 3 REPLACE study of Natpara™ in
hypoparathyroidism and one abstract related to PARADOX, a
374-patient epidemiology study that assessed the clinical, social,
and economic implications of hypoparathyroidism will be presented
at ENDO 2013, The Endocrine Society’s 95th Annual Meeting in San
Francisco, June 15-18, 2013.
Summarized below are the poster titles and presentation
times.
Abstract Title: The Effect of Recombinant Human Parathyroid
Hormone (rhPTH [1-84]) on Vitamin D Metabolism: Results from Phase
III REPLACE and Phase I Clinical StudiesPresenter: Dolores M
Shoback, MDAbstract Number: SUN-234Date: Sunday, June 16,
2013Session Information: Bone & Calcium Metabolism: Clinical
Trials & Case SeriesPresentation Time: 1:45 PM – 3:45 PM
Abstract Title: The Effect of Recombinant Human Parathyroid
Hormone (rhPTH [1-84]) on Phosphate Homeostasis in Patients with
HypoparathyroidismPresenter: Bart Clarke, MD, Mayo Clinic
Rochester, Rochester, MNAbstract Number: SUN-246Date: Sunday, June
16, 2013Session: Bone & Calcium Metabolism: Clinical Trials
& Case SeriesPresentation Time: 1:45 PM-3:45 PM
Abstract Title: Clinical Symptoms and Morbidities Reported among
Patients with Hypoparathyroidism: Patients' Attitudes and Responses
About hypoparathyroiDism tOleration eXplored (PARADOX
Study)Presenter: Bart Clarke, MD, Mayo Clinic Rochester, Rochester,
MNAbstract Number: SUN-249Date: Sunday, June 16, 2013Session: Bone
& Calcium Metabolism: Clinical Trials & Case
SeriesPresentation Time: 1:45 PM-3:45 PM
The ENDO abstracts are available online at the conference
website at
https://endo.confex.com/endo/2013endo/webprogram/COP.html.
About Hypoparathyroidism
Hypoparathyroidism is a rare endocrine disorder in which the
body produces insufficient levels of parathyroid hormone, the
principal regulator of calcium and phosphorus. When the body has
too little parathyroid hormone, blood calcium levels drop and
phosphorus levels increase, which can cause a number of physical
and mental symptoms, including uncontrollable muscle spasms and
cramps, tetany, seizures, fatigue, anxiety, and depression. There
is currently no FDA-approved replacement therapy for
hypoparathyroidism, which is currently managed with large doses of
calcium supplementation and active vitamin D therapy to raise the
calcium levels in the blood and reduce the severity of symptoms.
Over time, calcium may build up in the body and result in serious
health risks, including calcifications in the kidneys, heart or
brain. Hypoparathyroidism is believed to affect as many as 100,000
Americans.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a global biopharmaceutical company
pioneering and delivering therapies that transform the lives of
patients with rare diseases worldwide. The company’s lead product,
Gattex® (teduglutide [rDNA origin]) for injection (Revestive® (EU))
is approved in the U.S. for adult Short Bowel Syndrome (SBS)
patients who are dependent on parenteral support. NPS is also
developing Natpara® (rhPTH[1-84]) for the treatment of adult
hypoparathyroidism and, subject to the resolution of certain
manufacturing issues, expects to submit its Biologic License
Application (BLA) to the FDA in 2013.
NPS's earlier stage pipeline includes two calcilytic compounds,
NPSP790 and NPSP795, with potential application in rare disorders
involving increased calcium receptor activity, such as autosomal
dominant hypocalcemia with hypercalciuria (ADHH). NPS complements
its proprietary programs with a royalty-based portfolio of products
and product candidates that includes agreements with Amgen,
GlaxoSmithKline, Janssen Pharmaceuticals and Kyowa Hakko Kirin.
Additional information about NPS is available through its corporate
website, http://www.npsp.com.
“NPS,” “NPS Pharmaceuticals,” “Gattex,” “Natpara”, “Preotact”,
and “Revestive” are the company's trademarks.
Disclosure notice
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 the company'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.
Forward looking statements include, but are not limited to,
statements concerning the company’s future financial performance.
Risks associated to the company's business include, but are not
limited to, the risks associated with any failure by the company to
successfully commercialize Gattex (teduglutide [rDNA origin])for
injection, including the risk that physicians and patients may not
see the advantages of Gattex and may therefore be reluctant to
utilize the product, the risk that private and public payers may be
reluctant to cover or provide reimbursement for Gattex, the risk
that the company may be unable to resolve the manufacturing issue
in order to submit its BLA for Natpara, the risks associated with
the company's strategy, global macroeconomic conditions, the impact
of changes in management or staff levels, the effect of legislation
effecting healthcare reform in the United States, as well as other
risk factors described in the company's periodic filings with the
U.S. Securities and Exchange Commission, including its Annual
Report on Form 10-K and Form 10-Qs. All information in this press
release is as of the date of this release and NPS undertakes no
duty to update this information, whether as a result of new
information, future events or otherwise.
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