NPS Pharmaceuticals Highlights Hypoparathyroidism Data to be Presented at Annual Meeting of American Society for Bone and Mineral Research

-- Investigator-initiated studies highlight four-year results for NPSP558, as well as medical costs and co-morbidities of hypoparathyroidism –-

-- Abstracts available and can be viewed online at www.asbmr.org --

BEDMINSTER, N.J.--(BUSINESS WIRE)--Sep 16, 2011 - NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced that data about hypoparathyroidism will be presented at the 2011 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in San Diego, CA, September 16-20, 2011. NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), is currently in development as the first hormone replacement therapy for hypoparathyroidism. The presentations will include findings from investigator-initiated studies of rhPTH (1-84) and new information about the costs and co-morbidities associated with hypoparathyroidism.

“We believe the data being presented are very encouraging and further support the potential of using NPSP558 to treat the underlying cause of hypoparathyroidism by replacing the missing parathyroid hormone,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “These data also underscore the importance of individualizing replacement therapy for hypoparathyroidism patients, as we are doing it in our Phase 3 REPLACE study of NPSP558, which is on track for top-line results later this year.”

“Hypoparathyroidism has widespread consequences ranging from asymptomatic presentation to fatal hypocalcemia” Bart Clarke, MD, associate professor of medicine at the Mayo Clinic. “It is the only endocrine disorder for which we do not have a replacement hormone available to treat the underlying condition. Doctors currently can only provide supportive care aimed at managing the symptoms associated with hypocalcemia through calcium and vitamin D supplements. Patients are faced with striking a balance between managing their symptoms and avoiding the long-term risks associated with current treatments, which can result in kidney stones, kidney damage, and even kidney failure. Patients need better treatment options, ideally the ability to achieve a more physiological outcome by delivering the missing hormone.”

Identified below are the titles and links to the abstracts for the NPS and investigator-initiated research.

Oral Presentations:

PTH (1-84) Replacement Therapy in Hypoparathyroidism (HypoPT): A Randomized Controlled Trial on Pharmacokinetics and Dynamic Effects Following 24 Weeks of Treatment
Lead Author: Tanja Sikjaer, Aarhus University Hospital, Denmark
Abstract No. 1098
Sunday, September 18, 2011; 9:45 a.m. PT
http://www.asbmr.org/itinerary/presentationdetail.aspx?id=b7fbbfcd-358d-4991-8140-a1f2ac894068

Treatment of Hypoparathyroidism with PTH (1-84) Is Safe and Effective For Up to 4 Years
Lead Author: Natalie Cusano, Columbia University College of Physicians and Surgeons
Abstract No. 1097
Sunday, September 18, 2011; 9:30 a.m. PT
http://www.asbmr.org/itinerary/presentationdetail.aspx?id=5a8ab6b9-514b-4646-b9b3-1efec180773a

Poster Presentations:

Co-Morbid Medical Conditions Associated with Prevalent Hypoparathyroidism: A Population-Based Study
Lead Author: Bart Clarke, Mayo Clinic College of Medicine
Abstract No. SA0170
Saturday, September 17, 2011; 11 a.m. to 1 p.m. PT
http://www.asbmr.org/itinerary/presentationdetail.aspx?id=e58c43e8-4de4-499b-836b-46819db381f5

Medical Care Costs for Persons with and without Prevalent Hypoparathyroidism: A Population-Based Study
Lead Author: Cynthia Leibson, Mayo Clinic, Department of Health Sciences Research
Abstract No. MO0170
Monday, September 19, 2011; 11:30 a.m. to 1:30 p.m. PT
http://www.asbmr.org/itinerary/presentationdetail.aspx?id=5cc0292c-8d11-4986-8943-2f9c326f7ea5

Relationships Between Pharmacokinetic Profile of Human PTH(1-84) and Serum Calcium Response in Postmenopausal Women Following 4 Different Methods of Administration
Lead Author: John Fox, NPS Pharmaceuticals
Abstract No. MO0173
Monday, September 19, 2011; 11:30 a.m. to 1:30 p.m. PT
http://www.asbmr.org/itinerary/presentationdetail.aspx?id=b24b65ee-5b67-4cc6-b313-9657755b2c47

About Hypoparathyroidism

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, which can cause muscular and neurological symptoms, as well as bone impairments. There is no approved treatment for hypoparathyroidism. It is one of the few remaining hormone deficiency syndromes in which replacement therapy using the native hormone is not clinically available. Hypoparathyroidism is currently managed with large doses of oral calcium and active vitamin D supplementation 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.

About NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)

NPSP558, a bioengineered replica of human parathyroid hormone 1-84, is being evaluated in a Phase 3 registration study, known as REPLACE, as the first hormone replacement therapy for the underlying cause of hypoparathyroidism. Because it mimics the action of natural parathyroid hormone, NPSP558 has the potential to treat hypoparathyroidism and offer a more physiological treatment outcome than what is available with existing treatments.

Results from an investigator-initiated Phase 2 open-label proof-of-concept study demonstrated that NPSP558 potentially can be used as a therapeutic agent in hypoparathyroidism. The study showed that NPSP558 treatment in hypoparathyroidism significantly reduces supplemental calcium and 1,25-dihydroxy-vitamin D requirements while maintaining serum calcium levels. Data were published in January 2010 in the international peer-reviewed journal Osteoporosis International.

NPS has received orphan drug status for NPSP558 for the treatment of hypoparathyroidism. The company's partner Nycomed markets PTH (1-84) ex-US as Preotact(R) for the treatment of osteoporosis in post-menopausal women at high risk of fractures.

About NPS Pharmaceuticals

NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, GATTEX® (teduglutide) in short bowel syndrome (SBS) and NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) in hypoparathyroidism. NPS' 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, Kyowa Hakko Kirin, Nycomed, and Ortho-McNeil Pharmaceutical.

“NPS”, “NPS Pharmaceuticals”, and “GATTEX” are the company's registered trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.

 

Contact: NPS Pharmaceuticals, Inc.
Susan M. Mesco, 908-450-5516
smesco@npsp.com

 

 

Posted: September 2011

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