-----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, Spxq9CVKcPkBNRGPOvY0YG5cN4EBKok6zBxz039zIa1TVuZx6jX52iVqaseluKVp DeJB8dZWOM4l7qA+zqQn0w== 0001193125-07-211091.txt : 20071001 0001193125-07-211091.hdr.sgml : 20071001 20071001171742 ACCESSION NUMBER: 0001193125-07-211091 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070926 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071001 DATE AS OF CHANGE: 20071001 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: 071146827 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

September 26, 2007


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)

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 1.01 Entry into a Material Definitive Agreement.

On September 26, 2007 we entered into a definitive agreement which licenses to Nycomed the rights to develop and commercialize GATTEX(TM) (teduglutide) outside the United States, Canada and Mexico for the treatment of gastrointestinal disorders. Under the terms of the agreement, NPS has the potential to earn up to $185 million plus royalties. As an upfront payment, NPS will receive from Nycomed $35 million: a $10 million nonrefundable commitment fee upon signing the agreement and $25 million within two weeks following the announcement of topline results from the recently completed Phase 3 study of GATTEX in patients with short bowel syndrome (SBS), which is expected early in the fourth quarter of 2007. Nycomed has the right to end the collaboration within two weeks of the announcement of these results and forego the $25 million payment. In addition, NPS has the potential to earn more than $150 million in payments related to the attainment of certain regulatory milestones for the SBS indication, the successful development of new indications and the achievement of sales-based milestones. Additionally, the agreement provides for double-digit royalties on GATTEX sales in the Nycomed territories. NPS will complete the current GATTEX clinical program in short bowel syndrome and Nycomed will share future development costs 50:50 with NPS to advance and broaden the indications for GATTEX.

The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the agreement and the exhibits thereto, which will be attached to our periodic reports we file with the SEC.

 

Item 8.01 Other Events.

On September 26, 2007, NPS Pharmaceuticals issued the press release attached to this report as Exhibit 99.1, the contents of which are incorporated herein by this reference.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

99.1    Press Release issued by NPS Pharmaceuticals, Inc. on September 26, 2007.

 


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 1, 2007     NPS PHARMACEUTICALS, INC.
      By:  

/s/ VAL R. ANTCZAK

        Val R. Antczak, Senior Vice President, Legal Affairs, General Counsel and Secretary
EX-99.1 2 dex991.htm PRESS RELEASE ISSUED BY NPS PHARMACEUTICALS, INC. ON 9/26/07 Press release issued by NPS Pharmaceuticals, Inc. on 9/26/07

Exhibit 99.1

NPS Pharmaceuticals and Nycomed Announce Licensing Agreement for GATTEX(TM) in Territories Outside North America

PARSIPPANY, N.J. and ZURICH, Switzerland, Sept. 26 /PRNewswire-FirstCall/ — NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) and Nycomed announced today that they have entered into a definitive agreement which licenses to Nycomed the rights to develop and commercialize GATTEX(TM) (teduglutide) outside the United States, Canada and Mexico for the treatment of gastrointestinal disorders. NPS will retain the right to develop and commercialize GATTEX in North America.

Under the terms of the agreement, NPS has the potential to earn up to $185 million plus royalties. As an upfront payment, NPS will receive from Nycomed $35 million: a $10 million nonrefundable commitment fee upon signing the agreement and $25 million within two weeks following the announcement of topline results from the recently completed Phase 3 study of GATTEX in patients with short bowel syndrome (SBS), which is expected early in the fourth quarter of 2007. Nycomed has the right to end the collaboration within two weeks of the announcement of these results and forego the $25 million payment.

In addition, NPS has the potential to earn more than $150 million in payments related to the attainment of certain regulatory milestones for the SBS indication, the successful development of new indications and the achievement of sales-based milestones. Additionally, the agreement provides for double-digit royalties on GATTEX sales in the Nycomed territories. NPS will complete the current GATTEX clinical program in short bowel syndrome and Nycomed will share future development costs 50:50 with NPS to advance and broaden the indications for GATTEX.

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. A previous Phase 2 proof-of-concept clinical study in patients with SBS showed that daily subcutaneous injections of GATTEX resulted in significant growth of the intestinal lining and improved dietary absorption of nutrients and fluids. Once the company has completed its analysis of data from the Phase 3 SBS study, it expects to pursue a pre-NDA meeting with the U.S. Food and Drug Administration to discuss its potential plan for submitting a New Drug Application in mid-2008. 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.

NPS president and CEO Dr. Tony Coles stated, “This agreement expands our relationship with Nycomed and brings us an important strategic partner for GATTEX outside North America. The collaboration provides us with a partner that will help us pursue a full development program for GATTEX worldwide, not only in SBS, but potentially in


other indications, as well. We welcome this opportunity to collaborate with Nycomed to advance GATTEX in these key territories and look forward to our work together on realizing the full potential of this unique compound.”

Nycomed CEO Hakan Bjorklund stated, “We believe GATTEX has the potential to be an important new therapy for serious gastrointestinal conditions. We are excited to add GATTEX to our product pipeline, as it perfectly matches our development and marketing capabilities in the gastroenterology field. We look forward to developing GATTEX as a partner of NPS.”

Nycomed markets Preotact(R) (parathyroid hormone for injection) in the European Union under license from NPS and has rights to commercialize the drug in all territories outside the United States, Japan and Israel. Preotact is the European brand name for PREOS(R) which NPS licensed to Nycomed in 2004 for development and marketing in Europe as a treatment for osteoporosis in postmenopausal women.

About NPS

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 company’s website, http://www.npsp.com.

About Nycomed

Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets. The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners.

Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region, Nycomed has a presence in about 50 markets worldwide. Privately owned, the combined group had annual sales of approximately euro 3.4 billion and an EBITDA of euro 933.4 million (2006 results). For more information visit http://www.nycomed.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. 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. All information in this press release is as of September 26, 2007 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 for the year-ended December 31, 2006 and our Quarterly Report on Form 10-Q for the quarter-ended June 30, 2007.

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