-----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, HO4xpIXr1ESZ+SP1tCv9esSyj1RVV3ZvPVd5dZLe5SYEJHUdyvO9edotX6lM1A6J ImYfEitJfGyij6Qg32mI5A== 0001193125-08-016925.txt : 20080131 0001193125-08-016925.hdr.sgml : 20080131 20080131161045 ACCESSION NUMBER: 0001193125-08-016925 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080125 ITEM INFORMATION: Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080131 DATE AS OF CHANGE: 20080131 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: 08564729 BUSINESS ADDRESS: STREET 1: 550 HILLS DRIVE CITY: BEDMINSTER STATE: NJ ZIP: 07921 BUSINESS PHONE: (908) 450-5300 MAIL ADDRESS: STREET 1: 550 HILLS DRIVE CITY: BEDMINSTER STATE: NJ ZIP: 07921 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): January 25, 2008

 

 

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.)

550 Hills Drive, 3rd Floor

Bedminster, NJ 07921

(Address of principal executive offices)

(908) 450-5300

(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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(d) On January 25, 2008, the Board of Directors of NPS Pharmaceuticals, Inc. (the “Company”) appointed Dr. Francois Nader as a director of the Company. Dr. Nader is currently the Company’s Executive Vice President and Chief Operating Officer. A copy of the Company’s press release announcing Dr. Nader’s appointment is attached hereto as Exhibit 99.1.

There is no arrangement or understanding between Dr. Nader and any other person pursuant to which he was appointed as a director and the Company is unaware of any relationship or transaction requiring disclosure herein pursuant to Item 404(a) of Regulation S-K. At the present time, Dr. Nader is not expected to be appointed to serve on any committee of the Board of Directors. As an employee of the Company, Dr. Nader will not receive compensation for his services as a director.

 

Item 8.01 Other Events

On January 28, 2008, the Company issued a press release providing an update on GATTEX(TM) clinical development in short bowel syndrome. A copy of the Company’s press release is attached hereto as Exhibit 99.2

 

Item 9.01 Financial Statements and Exhibits

 

  (d) Exhibits

The following exhibits are filed with this Report on Form 8-K:

 

Exhibit No.

  

Description

99.1    Press release, dated January 30, 2008
99.2    Press release, dated January 28, 2008

 

-2-


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.

 

  NPS PHARMACEUTICALS, INC.
Date: January 30, 2008   By:  

/s/ Andrew Rackear

   

Andrew Rackear, Senior Vice President, Legal Affairs,

General Counsel and Secretary

 

-3-


Exhibit Index

 

Exhibit No.

  

Description

99.1    Press release, dated January 30, 2008
99.2    Press release, dated January 28, 2008

 

-4-

EX-99.1 2 dex991.htm PRESS RELEASE DATED JANUARY 30, 2008 Press Release Dated January 30, 2008

Exhibit 99.1

PRESS RELEASE                        

LOGO

NPS Pharmaceuticals Announces Board Appointments

BEDMINSTER, N.J., Jan. 30 — NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that its board of directors has elected Peter Tombros chairman of the board and appointed Francois Nader, M.D. as a director. Mr. Tombros joined the NPS board in 1998 and has served as lead director since 2006. Dr. Nader joined NPS in 2006 as chief medical and commercial officer and currently serves as executive vice president and chief operating officer. Dr. Nader’s appointment increases the number of board members to eight.

Mr. Tombros stated: “I am pleased to be leading the NPS board at this important point in the company’s history and look forward to working with the board and senior management to advance the NPS product portfolio. With the completion of the company’s restructuring last year, NPS is now in a much stronger financial position to execute successfully its clinical development plans for GATTEX and PREOS.”

Tony Coles, M.D., president and chief executive officer of NPS, stated: “I congratulate Peter on his appointment as chairman and look forward to his continued leadership of the NPS board. I also congratulate Francois on his appointment to the NPS board. Francois has brought strong management, strategic and clinical experience to NPS and his contributions as a director will be invaluable as we work to develop and gain approval for our most important assets, GATTEX and PREOS.”

Mr. Tombros is currently professor and executive in residence in the Eberly College of Science B.S. / M.B.A. Program at Pennsylvania State University. Prior to that, he was chairman of the board and chief executive officer of VivoQuest, a private biopharmaceutical company. From 1994 until June 2001, Mr. Tombros served as president, chief executive officer and director of Enzon Pharmaceuticals, Inc., a publicly held biopharmaceutical company. Prior to joining Enzon, Mr. Tombros spent 25 years with Pfizer Inc., a global healthcare company, in a variety of senior management positions including: vice president of marketing; senior vice president, and general manager of the Roerig Pharmaceuticals Division; executive vice president and director of Pfizer Pharmaceuticals Division; vice president of corporate strategic planning; and vice president, corporate officer of Pfizer Inc. In addition to NPS, Mr. Tombros serves on the boards of directors of Alpharma Inc., Cambrex, PharmaNet Development Group, Inc. and Protalex, Inc.

Dr. Nader is responsible for managing the company’s worldwide R&D, Commercial Operations, Manufacturing and Regulatory Affairs. Previously, he was a venture partner at Care Capital, LLC and chief medical officer of its Clinical Development Capital unit. Prior experience includes senior vice president, integrated healthcare markets and North America medical and regulatory affairs with Aventis Pharmaceuticals as well as similar positions at Hoechst Marion Roussel and its predecessor companies. Before joining Hoechst Marion Roussel, Dr. Nader served as head of global commercial operations at the Pasteur Vaccines division of Rhone-Poulenc.

About NPS Pharmaceuticals

NPS Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of 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. Additional information is available on the NPS website, http://www.npsp.com.


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 the company’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. Risks associated to NPS’s business include, but are not limited to, the risk of successfully executing its clinical development plans and gaining marketing approvals for GATTEX and PREOS, as well as other risks that are described in NPS’s periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ending December 31, 2006 and its Form 10-Q for the quarter ended September 30, 2007. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information.

EX-99.2 3 dex992.htm PRESS RELEASE DATED JANUARY 28, 2008 Press Release Dated January 28, 2008

Exhibit 99.2

PRESS RELEASE                        

LOGO

NPS Pharmaceuticals Provides Update on GATTEX(TM) Clinical Development in Short Bowel Syndrome

BEDMINSTER, N.J., Jan. 28 — NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced it expects to begin a confirmatory Phase 3 clinical study to evaluate GATTEX(TM) (teduglutide, recombinant GLP-2) in patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition (PN). At a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory requirements for the development of GATTEX for SBS, the FDA recommended that NPS conduct a confirmatory Phase 3 study prior to submitting a new drug application. NPS is finalizing a protocol for the confirmatory Phase 3 study to address the FDA’s comments and incorporate results from the ongoing Phase 3 extension study that will be available later this quarter.

Tony Coles, M.D., president and chief executive officer of NPS, stated: “We expect GATTEX to be a first-in-class therapy with the potential to create a new standard of care for patients suffering from short bowel syndrome and we greatly appreciate the FDA’s guidance as we work to complete the drug’s development for this indication. We look forward to concluding our discussions with the agency, as well as, working with our partner Nycomed to finalize the protocol for this confirmatory study. NPS expects to begin patient enrollment in the third quarter of this year.”

NPS expects the confirmatory study to be a placebo-controlled, multi-center study for the evaluation of GATTEX versus placebo in patients with PN-dependent SBS with an initial PN optimization and stabilization period followed by a dosing period of 24 weeks.

The Phase 3-extension study currently underway is evaluating GATTEX for PN-dependent SBS patients. Sixty-five patients (91%) who completed the pivotal Phase 3 study elected to enroll in the 28-week extension study. Patients already on GATTEX in the pivotal Phase 3 study continued to receive the dose to which they were randomized. Patients who received placebo in the earlier pivotal study were randomized to receive either a low dose of GATTEX (0.05 mg/kg/day) or a high dose of GATTEX (0.10 mg/kg/day).

Phase 3 Results

In October 2007, NPS reported positive top-line results from the company’s Phase 3 study of GATTEX in which 83 patients with short bowel syndrome (SBS) received either a low dose of GATTEX, (0.05 milligrams/kilogram/day), a higher dose (0.10 mg/kg/day) or placebo. The clinical efficacy endpoint of the study was a reduction in PN of at least 20% comparing baseline to weeks 16 to 24, measured as a graded response to capture reductions up to 100%. In an intent-to-treat analysis, forty-six percent (46%) of patients receiving the lower dose of GATTEX (N=35) responded and achieved a highly statistically significant reduction in PN compared to placebo (p=0.007). Twenty-five percent (25%) of patients receiving the higher dose of GATTEX (N=32) responded and showed a trend in the difference between the treatment group and placebo, but this did not reach statistical significance (p=0.161). Two low-dose patients gained independence from and discontinued PN by week 16 and a third high-dose patient discontinued PN at the end of treatment. The study’s criteria for conducting the statistical analysis of the primary endpoint required that the results for the high-dose group show statistical significance before the results of the low-dose group could be considered. Given the drug’s orphan designation in SBS and the statistically strong (p=0.007) and clinically meaningful findings in the low-dose group, the company met with the FDA to discuss the regulatory pathway for GATTEX.


About Short Bowel Syndrome (SBS)

SBS is a condition resulting from the surgical removal of significant portions of the bowel following injury or illness. There are 16,000 to 20,000 adult patients with SBS in the United States. Regulatory authorities in the U.S. and European Union have granted orphan drug status to teduglutide for its potential use, if approved, in treating SBS. Symptoms of SBS include diarrhea, dehydration, malnourishment, and weight loss caused by an inadequate absorption of nutrients and fluids from the diet. Long-term complications of the condition may include an increased risk of systemic infections due to the presence of an intravenous feeding line, degenerative changes in the bones and nerves due to vitamin and mineral deficiencies, and liver failure. Potential benefits derived from reduced dependence on intravenous feeding may include improved nutrition, lower rates of infections, and improved quality of life due to more time away from intravenous feeding, which may provide greater mobility and improved sleep. More information about SBS is available on the website, http://www.shortbowel.com and http://www.glucagon.com.

About GATTEX(TM)

A potential first-in-class drug, GATTEX is a proprietary analog of naturally occurring human glucagon-like peptide 2 (GLP-2), a peptide secreted primarily in the distal intestine and involved in the regeneration and repair of the intestinal epithelium. NPS is also pursuing development of GATTEX as a possible treatment for chemotherapy-induced gastrointestinal mucositis in cancer patients and necrotizing enterocolitis in preterm infants.

About NPS Pharmaceuticals

NPS Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of 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. Additional information is available on the NPS website, http://www.npsp.com.

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 the company’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. Risks associated to NPS’s business include, but are not limited to, the risk of obtaining the necessary regulatory approvals for GATTEX, as well as other factors expressed in NPS’s periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information.

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-----END PRIVACY-ENHANCED MESSAGE-----