-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KUT52RM7DGx2I3UxXFH9sQbI75tYbRBJ2s3YnkidIfYceDYYCmzLrGmEYx31ApVh h1neBDX7Ac/VNPhK94UHbw== 0000897069-04-001819.txt : 20041021 0000897069-04-001819.hdr.sgml : 20041021 20041021102938 ACCESSION NUMBER: 0000897069-04-001819 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041021 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041021 DATE AS OF CHANGE: 20041021 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NPS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000890465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 870439579 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23272 FILM NUMBER: 041088852 BUSINESS ADDRESS: STREET 1: 420 CHIPETA WAY STE 240 CITY: SALT LAKE CITY STATE: UT ZIP: 84108-1256 BUSINESS PHONE: 8015834939 8-K 1 cmw976.htm CURRENT REPORT




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

October 21, 2004
Date of Report (Date of earliest event reported)

NPS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware
0-23272
87-0439579
(State or other jurisdiction of (Commission File Number) (I.R.S. Employer
incorporation) 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)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))






Item 8.01 Other Events.

        On October 21, 2004, the Company issued a press release regarding TOP study data presented in connection with the American College of Rheumatology scientific meetings in San Antonio, Texas, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.



Item 9.01 Financial Statements and Exhibits.

  (c) Exhibits

  99.1 Press Release issued by the Company on October 21, 2004.



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:  October 21, 2004 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 October 21, 2004.




















EX-99 2 cmw976b.htm PRESS RELEASE

[GRAPHIC OMITTED][NPS LOGO]

For Immediate Release Contact:  David L. Clark
Vice President, Corporate Affairs
NPS Pharmaceuticals, Inc.
(801) 583-4939

NPS PHARMACEUTICALS PRESENTS
ADDITIONAL TOP STUDY DATA AT ACR

PREOS® Shown to Protect Against First and Subsequent Fracture
in Postmenopausal Osteoporotic Women

        Salt Lake City — October 21, 2004 – NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced additional results from its pivotal Phase III TOP Study with PREOS® (parathyroid hormone), which suggest for the first time that an anabolic agent can reduce the risk of a first vertebral (spinal) fracture in postmenopausal osteoporotic women. In the study, PREOS also reduced the incidence of new vertebral fractures in patients who had already fractured. These data were featured in a late-breaking oral presentation at the 68th Annual Scientific Meeting of the American College of Rheumatology in San Antonio.

        “Vertebral fractures can cause a great deal of discomfort, and they increase a patient’s morbidity and mortality. Additionally, once a patient has experienced a spinal fracture, the risk of future fracture increases dramatically,” said Mark P. Ettinger, M.D., F.A.C.R., Medical Director Emeritus, Radiant Research and The Regional Osteoporosis Center, Stuart, Florida. “This study is very important because it shows that an agent such as PREOS, which has been shown to increase new bone formation over an 18-month period, can prevent both first-time and additional recurrent fractures. Clinical data from the PaTH trial, and now the fracture results from the TOP study, challenge current treatment paradigms by suggesting that high-risk osteoporotic women can benefit from the administration of parathyroid hormone before they experience a first fracture.”

TOP Study Details

        In the 18-month “Treatment of Osteoporosis with Parathyroid Hormone (PTH)” study, approximately 2,600 postmenopausal osteoporotic women were randomized to receive either a daily subcutaneous injection of 100 micrograms of PREOS or placebo, in addition to daily calcium and vitamin D supplements. The average age of the women in this study was 64 years. At baseline, the mean serum calcium level for all patients was 9.7 milligrams per deciliter (mg/dL), and 9% of patients had levels greater than 10.2 mg/dL. Women in the TOP study were not specifically tested for either hyperparathyroidism or a vitamin D deficiency, factors that can affect serum calcium levels. The mean spine, total hip and femoral neck bone mineral density (BMD) T-scores at baseline were -3.0, -1.9 and -2.2, respectively, and 19% of patients had a prevalent vertebral fracture.


        NPS previously reported that the administration of PREOS resulted in a new or worsened vertebral fracture risk reduction of 59% in all patients who received at least one dose of drug or placebo (intent-to-treat patients). Dr. Ettinger et al. expanded on the previous report by including data from patients who took at least 75% of their prescribed doses and had no other protocol violations (per protocol patients, n=1,870). In these patients the new vertebral fracture incidence (VFI) was significantly lower in the PREOS group than the placebo group (1.14% vs. 3.33%, respectively), and PREOS-treated patients had a relative fracture risk reduction (RFRR) of 66%. In those with a prevalent vertebral fracture, PREOS decreased new VFI from 8.38% to 2.63%, which translates to a 69% RFRR. In those without a prevalent vertebral fracture, PREOS decreased new VFI from 2.22% to 0.83%, which represents a 63% RFRR. At the end of the 18-month study period, per protocol patients treated with PREOS experienced significant increases in mean spine, total hip, and femoral neck BMD compared to patients who received placebo.

        In the study, PREOS was generally well tolerated. The percentage of patients who experienced adverse events and serious adverse events was comparable in the PREOS-treated and placebo groups. Approximately 16% of patients in the PREOS group and 12% of patients in the placebo group discontinued the study due to adverse events.

        As in previous PTH studies, TOP study increases in calcium were generally transient. Over the course of the study, a total of 21% of PREOS-treated patients and 3% of patients in the placebo group experienced a measurement of baseline serum calcium greater than 10.7 mg/dL. Only 0.7% of PREOS-treated patients discontinued the study due to increased serum calcium. Other PREOS-treated patients who discontinued the study reported headache (1.4%), dizziness (0.8%), nausea (4.4%), vomiting (1.1%), and elevated urine calcium (2.4%). These same adverse events were reported by a total of 2% of patients in the placebo group who discontinued the study.

About NPS Pharmaceuticals

        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 discovery research effort. Additional information is available on the company’s website, http://www.npsp.com.




2


Safe Harbor Statement

        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 likelihood that PREOS will be an appropriate therapy for patients who have osteoporosis and our intent to commercialize small molecules and recombinant proteins as drugs. 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: we have never filed an NDA and may not be able to do so in a timely manner; 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 October 21, 2004, 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/A for the year ended December 31, 2003, and our Quarterly Report on Form 10Q for the quarter ended June 30, 2004.

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