(NPSP) Introduces Emergency Resources Kit for Patients
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced its support for World Hypoparathyroidism Awareness Day by introducing a free Emergency Resources Kit designed to support accurate and more rapid diagnosis of Hypoparathyroidism symptoms in emergency care and other medical care settings. The annual global observance encourages the public to increase awareness of the disorder and the need for more education, improved diagnosis, and new treatment options.
The Hypoparathyroidism Emergency Resources Kit includes an ID bracelet, wallet card and key chain tag that indicate that someone is living with Hypoparathyroidism. By carrying any of these identifiers, patients and caregivers may be better able to alert healthcare providers when someone is affected by symptoms associated with Hypoparathyroidism including seizures, tetany (severe cramping), cardiac abnormalities or spasms that may lead to an obstructed airway. Emergency Resources Kits are available free of charge and can be ordered by visiting www.hypoparathyroidism.com, an NPS Pharma website.
“NPS Pharma is honored to be joining the global Hypoparathyroidism community in recognizing World Hypoparathyroidism Awareness Day by increasing awareness and understanding of this rare, complex endocrine disorder,” said Francois Nader, MD, president and chief executive officer of NPS Pharma. “We developed the Emergency Resources Kits based on feedback from patients living with Hypoparathyroidism to make it easier for healthcare providers to identify the symptoms of the disorder, especially in people who may be incapacitated or unable to clearly describe their symptoms.”
Hypoparathyroidism is a rare 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. The most common cause of hypoparathyroidism is injury to or removal of the parathyroid glands during surgery for thyroid cancer or other forms of neck surgery, but the disorder can also be genetic, and in some cases its cause is unknown.
In addition to making it easier for patients to indicate that they are afflicted by Hypoparathyroidism, NPS Pharma is also continuing its ongoing support for the Hypoparathyroidism community in many other ways. The company provides an informational web site called Hypoparathyroidism Answers, publishes a free e-book called Getting Clarity on Hypoparathyroidism, and has coordinated an ambassador program to help people affected by this disorder to educate and support others who may also be affected. These resources are available at www.hypoparathyroidism.com.
World Hypoparathyroidism Awareness Day was initiated in 2011 by the Hypoparathyroidism Association, the first non-profit group in the U.S. that advocates exclusively for patients living with Hypoparathyroidism. The 2014 edition of World Hypoparathyroidism Awareness Day coincides with the organization’s upcoming patient conference being held from June 5 – 7 in Sacramento, California.
About Hypoparathyroidism
PTH plays a central role in a variety of critical physiological functions, including closely modulating serum calcium and phosphate, regulating renal excretion of calcium and phosphate, activating vitamin D, and maintaining normal bone turnover. In patients with hypoparathyroidism, insufficient levels of PTH lead to low serum calcium, high serum phosphate, increased urinary calcium excretion, and decreased urinary phosphorus excretion. PTH deficiency can also disrupt skeletal homeostasis, leading to bone abnormalities. In addition, patients with insufficient levels of PTH are unable to convert native vitamin D into its active state to properly absorb dietary calcium.
Acute symptoms of hypoparathyroidism are largely due to hypocalcemia and include fatigue, muscle spasms and cramps, tingling, tetany, seizures, brain fog/mental lethargy, anxiety, and depression. In the absence of an approved parathyroid replacement therapy, the standard approach focuses on using therapeutic doses of calcium and active vitamin D to increase calcium levels in the blood and reduce the severity of hypocalcemic symptoms. However, balancing the administration of supplements is challenging due to calcium fluctuations and the long-term use of high doses of calcium and vitamin D may lead to serious complications, including long-term renal damage. In addition, because serum phosphate levels are elevated when PTH is missing, increasing serum calcium may lead to irreversible calcium-phosphate deposits in the kidneys, arteries or brain. Further, supplements do not correct the abnormal bone metabolism due to PTH deficiency or enable the activation of vitamin D.
About NPS Pharma
NPS Pharma is a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases. The company’s lead product, Gattex® (teduglutide [rDNA origin]) for injection is approved in the US for adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. In the EU, teduglutide (trade name: Revestive®) is approved for the treatment of adult patients with SBS; patients should be stable following a period of intestinal adaptation after surgery. Teduglutide is not approved for the treatment of pediatric SBS patients. The safety, pharmacokinetics, and pharmacodynamics of teduglutide in this population is currently being evaluated in a global trial.
A Biologics License Application is undergoing FDA review for Natpara® (rhPTH [1-84]) for the treatment of hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone. The Prescription Drug User Fee Act goal date for the Natpara application is October 24, 2014.
NPS Pharma’s earlier stage pipeline includes NPSP795, a calcilytic compound with potential application in rare disorders involving increased calcium sensing receptor activity, such as autosomal dominant hypocalcemia (ADH). NPS Pharma 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 Pharma is available through its corporate website, http://www.npsp.com.
“NPS,” “NPS Pharma,” “NPS Pharmaceuticals,” “Gattex,” “Natpara,” “Natpar,” “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 and plans for the commercialization of its products, beliefs or expectations regarding our products in development, statements concerning the company’s plans for international expansion, beliefs or expectations regarding potential revenue and earnings from product sales, including beliefs regarding our ability to grow sales, expectations regarding the market size for our products, including those in development, and beliefs or expectations regarding our operating expenses. 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/Revestive (teduglutide [rDNA origin]) for injection, including the risk that physicians and patients may not see the advantages of Gattex/Revestive 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, risks related to regulatory approvals for recombinant human parathyroid hormone 1-84 (rhPTH [1-84]), 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 press 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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