-----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, SkRaaZc0BgEyMDANaWAXqiNpzfndhO+EtIQGN3ip13Olu/7spLL+dXDMTimA2pG3 ASTsgIBMXS7o/vxnFvJjmQ== 0001193125-04-169854.txt : 20041012 0001193125-04-169854.hdr.sgml : 20041011 20041012110102 ACCESSION NUMBER: 0001193125-04-169854 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041011 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041012 DATE AS OF CHANGE: 20041012 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: 041073784 BUSINESS ADDRESS: STREET 1: 420 CHIPETA WAY STE 240 CITY: SALT LAKE CITY STATE: UT ZIP: 84108-1256 BUSINESS PHONE: 8015834939 8-K 1 d8k.htm FORM 8-K Form 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)    

  October 11, 2004

 

 

 

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)

 

(IRS Employer

Identification No.)

 

 

420 Chipeta Way Salt Lake City, Utah   84108
(Address of principal executive offices)   (Zip Code)

 

 

Registrant’s telephone number, including area code       (801) 583-4939

 

 

 

 
(Former name or former address, if changed since last report)

 

 

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 11, 2004, the Company issued a press release announcing results of its migraine study, 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 11, 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 12, 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 11, 2004.

 

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

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

 

NPS REPORTS INCONCLUSIVE RESULTS

OF ACUTE MIGRAINE STUDY

 

Salt Lake City — October 11, 2004 — NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that the results of its proof-of-concept study with the experimental compound NPS 1776 (isovaleramide) in patients with moderate to severe migraine headaches were inconclusive due to a higher than expected placebo response. The drug failed to meet the study’s primary endpoint, which was a significant reduction in headache pain at two hours after administration of drug compared to placebo. A total of 189 people with moderate to severe migraine pain presented themselves to investigators and were randomly assigned to receive either a high dose (800 mg) or a low dose (400 mg) of drug, or a placebo. A positive response was measured in 60 percent of subjects receiving the high dose of drug, in 64 percent of subjects receiving the low dose of drug, and in 56 percent of those receiving placebo.

 

Analysis of the study results showed that there were no serious adverse events in any of the subjects, and adverse events of any kind were infrequent and evenly distributed between the study groups. The pharmacokinetic profile of NPS 1776 in patients who received the drug showed peak blood concentrations were achieved at 30 minutes post-dose.

 

The company will complete its evaluation of data from this study, and plans to continue to explore the development of NPS 1776 in other indications supported by evidence from previously conducted preclinical studies of the compound.

 

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.

 

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 related to 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: 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 11, 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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