8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported) September 8, 2003

NPS PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware	0-23272	87-0439579
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

420 Chipeta Way

Salt Lake City, Utah 84108

(Address of Principal Executive Offices)

(801) 583-4939

(Registrant’s Telephone Number, Including Area Code)

ITEM 5: Other Events

On September 8, 2003, the Company issued a press release, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.

On September 20, 2003, the Company issued a press release, a copy of which is attached hereto as Exhibit 99.2 and incorporated herein by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: September 25, 2003	NPS PHARMACEUTICALS, INC.
	By:	/s/    HUNTER JACKSON
		Hunter Jackson CEO, President and Chairman of the Board

EXHIBIT INDEX

Exhibit Number	Description
99.1	Press Release issued by NPS Pharmaceuticals, Inc. on September 8, 2003 announcing the NDA filing by Amgen Inc. for Cinacalcet HCl.
99.2	Press Release issued by NPS Pharmaceuticals, Inc. on September 20, 2003 commenting on interim results of PaTh Study Data.

EX-99.1

Exhibit 99.1

NPS Pharmaceuticals Announces NDA Filing by Amgen for Cinacalcet HCL

9/8/2003 10:49:00 PM

SALT LAKE CITY, Sept. 8 /PRNewswire-FirstCall/ — NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that its licensee, Amgen Inc. of Thousand Oaks, CA, has submitted a new drug application (NDA) to the United States Food and Drug Administration seeking approval to market cinacalcet HCl as a therapy for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients. Cinacalcet HCl is the first NPS compound to be the subject of an NDA. Under the terms of its license agreement with Amgen, NPS will receive a milestone payment of $6 million as a result of this regulatory filing.

Cinacalcet HCl is Amgen’s first small molecule therapeutic and represents an important milestone for Amgen and furthers the company’s commitment to the nephrology community. It also represents a potentially significant advance for chronic kidney disease patients diagnosed with SHPT, a common yet serious metabolic disorder where parathyroid hormone levels are elevated. Patients with this disease can suffer from bone disease, bone pain and fractures, soft tissue calcification, vascular calcification and cardiovascular complications.

Cinacalcet HCl is an oral compound with a unique mechanism of action that modulates the behavior of the calcium-sensing receptor on the parathyroid gland. By increasing sensitivity of the receptors to calcium levels in the bloodstream, cinacalcet HCl may lead to a reduction in the levels of parathyroid hormone, calcium, phosphorous and the calcium-phosphorous product. Currently, there are no therapies available that have these features.

“As a first-in-class compound, cinacalcet HCl is an important new therapy for a serious medical condition in CKD patients,” said Hunter Jackson, Ph.D., NPS Chairman and CEO. “We are extremely proud of our role in discovering this compound and congratulate Amgen on successfully reaching this important point in the development of this promising new therapy for secondary hyperparathyroidism. Submission of this NDA also represents an important milestone for NPS and another step toward our goal of becoming a fully integrated pharmaceutical company. Looking ahead, we believe the NPS portfolio of products has the potential to achieve similar success in a variety of therapeutic areas.”

Amgen licensed cinacalcet HCl from NPS in 1996. Under the agreement with NPS, Amgen has the right to sell the compound on a worldwide basis except in Japan, Korea, Taiwan, and China where rights to the molecule have been licensed to the pharmaceutical division of Kirin Brewery. In addition to the milestone payment due NPS related to filing the NDA, Amgen will pay NPS royalties on sales of cinacalcet HCl if the drug is approved for marketing.

NPS discovers, develops and intends to commercialize 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 backed by a strong drug discovery effort. The two most advanced product candidates are PREOS(TM), being developed for the treatment of osteoporosis, and cinacalcet HCl. Additional information is available on the company’s website, http://www.npsp.com.

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. Such statements include those regarding our goal of becoming a fully-integrated pharmaceutical company, our intention to commercialize small molecules and recombinant proteins as drugs and our achievement of similar success in a variety of therapeutic areas. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described herein. Such risks and uncertainties include: we do not have and may never develop any products that generate revenues; our product candidates may not prove to be safe or efficacious; the FDA may delay approval or may not approve any of our product candidates; current collaborators or partners may not devote adequate resources to the development and commercialization of our licensed drug candidates which would prevent or delay introduction of drug candidates to the market; we may be unable to generate adequate sales and marketing capabilities to effectively market and sell our products; and failure to secure adequate manufacturing and storage sources for our products could result in disruption or cessation of our clinical trials and eventual commercialization of such products; and we may not have or be able to secure sufficient capital to fund

development and commercialization of our product candidates. All information in this press release is as of September 8, 2003, and we undertake no duty to update this information. A more complete description of these risks can be found in our Annual Report on Form 10K/A for the year ended December 31, 2002 and in our quarterly report on Form 10-Q for the second quarter of 2003 filed with the Securities and Exchange Commission.

SOURCE NPS Pharmaceuticals, Inc.

CONTACT: David L. Clark, Vice President, Operations of NPS Pharmaceuticals, Inc., +1-801-583-4939

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20000218/NPSLOGO

PRN Photo Desk, photodesk@prnewswire.com

Company News On-Call: http://www.prnewswire.com/comp/613587.html

Web site: http://www.npsp.com

http://www.prnewswire.com

EX-99.2

Exhibit 99.2

NPS Comments on Interim Results of PaTH Study Data

9/20/2003 1:32:00 PM

Results Indicate Parathyroid Hormone (PTH) May Play an Important Role in Treating Osteoporotic Women

No Synergy Seen in Combining Osteoporosis Drugs

SALT LAKE CITY, Sept. 20 /PRNewswire-FirstCall/ — Interim results presented today suggest that parathyroid hormone (PTH 1- 84) may be more effective than the combination of PTH and alendronate, and alendronate alone, in promoting bone formation in post-menopausal osteoporotic women. The results came from a clinical study called “PaTH” (PTH/alendronate) presented today at the 25th Annual Meeting of the American Society of Bone and Mineral Research in Minneapolis and published in the latest edition of The New England Journal of Medicine (NEJM). Dennis M. Black, Ph.D., Department of Epidemiology and Biostatistics, University of California, San Francisco presented the results at the conference and authored the NEJM article. NPS Pharmaceuticals (Nasdaq: NPSP) supplied PTH, or PREOS(TM) for the study. The study was supported by the National Institute of Arthritis, Musculoskeletal and Skin Disorders (NIAMS), part of the National Institutes of Health.

In the 238-patient PaTH study, post-menopausal women with low hip or spine bone mineral density (BMD) scores who had not been treated with alendronate were randomized to receive a daily regimen of subcutaneous injections of PTH, alendronate, or PTH and alendronate together for 12 months. All patients received daily supplemental calcium and multivitamins. Using x-ray and quantitative computed tomography (QCT) imaging techniques, researchers measured the effects of parathyroid hormone and alendronate at various skeletal sites. BMD increases in the spine were similar for the PTH and the PTH/alendronate combination treatment groups, and higher (statistically nonsignificant) in these groups than in the alendronate alone group. Trabecular spine volumetric BMD increased substantially in all three treatment groups, but twice as much in the PTH-treated group than in the combination group, and nearly three times as much as in the alendronate alone group. Hip BMD increased most in the alendronate group, followed by a smaller increase in the combination treated group, and a significantly smaller increase in the PTH group. However, of particular note was that cortical bone volume in the hip was shown to increase significantly with PTH alone and did not increase with alendronate alone, or the combination as measured by QCT. Markers of bone formation and resorption both increased notably in the PTH group but not in the combination group or the alendronate group.

“Use of QCT allowed us for the first time to monitor changes in trabecular and cortical bone in a group of patients on PTH. The data confirm that full- length PTH has the anticipated anabolic effect on markers of bone turnover and that PTH produces significant increases in trabecular bone at the hip and spine. PTH represents the first in a new class of therapies that offer physicians a real alternative to antiresorptive drugs,” said Dennis M. Black, Ph.D.

“Osteoporosis is, and will continue to be, a major economic burden to our society and new therapies are needed to address the fundamental problem of bone loss. While there are several therapies that prevent bone degradation, this study provides further evidence that PTH promotes the growth of structurally normal, fracture resistant bone in women with osteoporosis,” said Hunter Jackson, Ph.D., Chairman and CEO of NPS Pharmaceuticals. “These data extend earlier findings and signal that there may be an important role for PTH in treating osteoporotic women based on the positive effect that PTH has on bone formation.”

The PaTH study results presented by Dr. Black are interim results of an on-going, two-year study. In the second year of the study patients will discontinue PTH injections, and will receive alendronate therapy or placebo to allow investigators to assess the effect of the sequential use of PTH and alendronate.

About Preos

PREOS is recombinantly produced, full-length human parathyroid hormone (PTH). The importance of calcium for healthy bones is well known. Less widely appreciated is the critical role PTH plays in the regulation of calcium

physiology and bone replacement processes. There is now substantial evidence that injections of PTH can stimulate the growth of structurally normal new bone in cases where bone has been lost to osteoporosis.

In addition to the PaTH study, NPS has other ongoing clinical trials including a Phase III study termed the Treatment of Osteoporosis with PTH, or TOP Study, a double-blind, placebo-controlled, multi-center trial designed to measure increases in bone mineral density and determine PREOS’ effectiveness in fracture reduction. NPS is also conducting a clinical trial called the PTH for Osteoporotic Women on Estrogen Replacement, or POWER Study being conducted at centers in Europe, which is the largest pharmaceutical market for osteoporosis outside the United States.

About Osteoporosis

Osteoporosis is a major public health threat for an estimated 44 million Americans. Ten million individuals are estimated to already have the disease and almost 34 million more have low bone mass, placing them at risk for osteoporosis. One in two women and one in four men over the age of 50 will have an osteoporosis related fracture in their lifetime, and the estimated cost for treating these fractures is more than $17 billion per year.

Conference Call and Webcast Information

NPS will update the investment community on PaTH study interim results in a conference call to be held Monday, September 22, 2003 at 9:45 a.m. EDT. Hunter Jackson, Ph.D. will host the call, which will feature Dr. Dennis Black and members of the NPS senior management team.

To participate in the call, dial (800) 374-0232 and use participant code 2856242. A live webcast of the event may be accessed on the Investor Relations page, Calendar of Events section of the company’s website, www.npsp.com. Please click on the webcast link and follow the prompts for registration and access.

If you are unable to participate in the live call, a replay will be available at (800) 642-1687 (with participant code 2856242) until midnight, EDT, September 29, 2003. The webcast will be available on the NPS site for the same period of time.

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. Such statements include those regarding the efficacy of PREOS and its ability to treat osteoporosis. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described herein. Such risks and uncertainties include: we do not have and may never develop any products that generate revenues; our product candidates may not prove to be safe or efficacious; the FDA may delay approval or may not approve any of our product candidates; current collaborators or partners may not devote adequate resources to the development and commercialization of our licensed drug candidates which would prevent or delay introduction of drug candidates to the market; we may be unable to generate adequate sales and marketing capabilities to effectively market and sell our products; failure to secure adequate manufacturing and storage sources for our products could result in disruption or cessation of our clinical trials and eventual commercialization of such products; and we may not have or be able to secure sufficient capital to fund development and commercialization of our product candidates. All information in this press release is as of September 20, 2003, and we undertake no duty to update this information. A more complete description of these risks can be found in our Annual Report on Form 10K/A for the year ended December 31, 2002 and in our quarterly report on Form 10-Q for the second quarter of 2003 filed with the Securities and Exchange Commission.

SOURCE NPS Pharmaceuticals, Inc.

CONTACT: David L. Clark, Vice President, Operations of NPS Pharmaceuticals, Inc., +1-801-583-4939

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20000218/NPSLOGO

PRN Photo Desk, photodesk@prnewswire.com

Company News On-Call: http://www.prnewswire.com/comp/613587.html

Web site: http://www.npsp.com

http://www.prnewswire.com