-----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, KP2diEkBIWHNeN3bXPexh4zc9r2euXp/x1Fd+iN4SkfZItBu2yxzndAF0P9Eo0Yr IKYDIVfNkSQJRA6H/XNLPg== 0001193125-05-021062.txt : 20050207 0001193125-05-021062.hdr.sgml : 20050207 20050207172055 ACCESSION NUMBER: 0001193125-05-021062 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050207 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050207 DATE AS OF CHANGE: 20050207 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: 05581378 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

 

February 7, 2005

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 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)

 


 

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 February 7, 2005, the Company issued a press release regarding the PREOS NDA process and timing; a copy of the press release 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 February 7, 2005.


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: February 7, 2005   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 February 7, 2005.
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 PROVIDES UPDATE ON PREOS® NDA PROCESS AND TIMING

 

Salt Lake City, Utah — February 7, 2005 — NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that the company will extend the time it will take to prepare the U.S. new drug application (NDA) for its osteoporosis drug candidate PREOS in light of the European deadlines and filing requirements of its partner Nycomed, and the complex process of incorporating data from multiple clinical studies into different regulatory submission documents.

 

The company noted that Nycomed intends to submit a marketing authorization application in Europe next month for approval to sell PREOTACT (the European brand name for PREOS or PTH), and that NPS is applying resources from its U.S. NDA team in a cooperative effort to meet the submission deadline assigned to Nycomed by the European Medicines Agency. NPS will submit its U.S. NDA following the Nycomed submission as soon as it has completed and electronically formatted all of the documents necessary for a successful U.S. marketing application.

 

Hunter Jackson, Ph.D., Chairman, President, and CEO of NPS, said, “We are nearing completion of the NDA for PREOS and believe we have a very strong data package to support the approval of this investigational therapy for postmenopausal osteoporosis. Although we will extend our submission date beyond the end of February, we expect the delay will be brief and that the extra effort and time we are choosing to take will facilitate productive regulatory reviews in the U.S. and in Europe, which will allow us to achieve a timely and coordinated PREOS launch.”

 

About PREOS

 

PREOS is recombinant full-length human parathyroid hormone (PTH 1-84). NPS has studied PREOS in a number of clinical settings to assess its safety and its effect on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the potential of PTH (1-84) to reduce the risk of vertebral fractures in post-menopausal women. In the TOP study PREOS demonstrated a statistically significant reduction in the risk of new or worsened vertebral fractures in women with and without osteoporosis-related fractures prior to entering the study. Results from the TOP study will be the foundation of the U.S. and European marketing applications.

 

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 regarding our expectation that Nycomed will file a European marketing application in March 2005, our expectation that the delay in filing the U.S. NDA will be brief, 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 cannot assure that Nycomed will timely file a European marketing


application for PREOS; 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 February 7, 2005, 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 September 30, 2004.

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