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NPS Pharmaceuticals, Inc. Announces Progression of the Calcilytics Development Program in Osteoporosis by GlaxoSmithKline

Published: Jun 05, 2007

PARSIPPANY, N.J., June 4 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. today announced that GlaxoSmithKline (GSK), under a collaboration agreement between the two companies, has dosed the first patient in a Phase II dose-range finding study with the investigational calcilytic compound 751689 in post-menopausal women with osteoporosis.

The Phase II, double blind, placebo-controlled study will evaluate the efficacy and safety of compound 751689 over a twelve month period. The study will enroll approximately 520 post-menopausal women with osteoporosis and is designed to assess the overall efficacy, safety, and tolerability of 751689 in comparison with placebo and two active comparators. Outcome measures include bone mineral density of the lumbar spine and hip, vertebral and hip strength parameters, and biomarkers of bone turnover. Data from this study, along with other data, will be used to select a dose of compound 751689 for further evaluation.

NPS CEO and president, Tony Coles, M.D., stated, "We are pleased that the development of the calcilytics program is advancing under GSK's leadership. We believe that calcilytics have the potential to represent an important new class of drugs for the treatment of osteoporosis and look forward to the results of this exciting trial."

Under the terms of the Collaborative Research and License Agreement with GSK, NPS will receive royalties on global product sales and has the option to co-promote products resulting from the collaboration with GSK in the United States.

ABOUT CALCILYTICS

Calcilytics are novel small molecules that work by antagonizing calcium-sensing receptors on the surface of the parathyroid gland, thereby triggering a transient release of the body's own stores of parathyroid hormone (PTH). This release of PTH may have the potential to rebuild the bone mass lost as a result of osteoporosis and improve overall bone microarchitecture in these patients. NPS and GSK have previously disclosed that in animal models, daily oral administration of a calcilytic compound was shown to stimulate new bone formation, increase bone mineral density (BMD) at vertebral and non-vertebral skeletal sites, and increase biomechanical parameters of bone strength.

ABOUT NPS

NPS Pharmaceuticals is engaged in the discovery, development and commercialization of therapeutic small molecules and recombinant proteins to treat bone and mineral and gastrointestinal disorders.

NPS's first approved product, cinacalcet HCl, is marketed in the United States by Amgen under the brand name Sensipar(R) as a treatment for secondary hyperparathyroidism. NPS partner Kirin is developing cinacalcet HCl as a treatment for this condition in Japan.

The company's Phase 3 drug candidates are PREOS(R) (parathyroid hormone [rDNA origin] for injection) for the treatment of osteoporosis, and teduglutide for gastrointestinal disorders including Short Bowel Syndrome. Teduglutide has been granted orphan drug status in the United States and Europe for this condition.

The company's earlier-stage drug candidates include antagonists of metabotropic glutamate receptors to treat neurological and psychiatric conditions (partner: AstraZeneca), and glycine reuptake inhibitors to treat schizophrenia (partner: Johnson & Johnson). Additional information is available on the company's website, http://www.npsp.com.

Cautionary Statement for the Purpose of the "Safe Harbor" Provisions

of the Private Securities Litigation Reform Act of 1995

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. Such risks and uncertainties include: drug candidates under our calcilytics collaboration with GlaxoSmithKline (GSK) may not prove to be safe or efficacious in future clinical trials and the FDA may delay approval or may not approve such drug candidates; we are entirely dependent upon GSK for the development and commercialization of drug candidates under our calcilytics collaboration; and if GSK does not devote adequate resources to the development and commercialization of our partnered drug candidates, completion of clinical trials and the commercialization of any approved drug candidate would be delayed. All information in this press release is as of May 23, 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 March 31, 2007.

NPS Pharmaceuticals, Inc.

CONTACT: Brandi Simpson, Sr. Director, Investor Relations of NPSPharmaceuticals, Inc., +1-801-883-2397

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