-----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, Qa3UbDQx+hrQMeiuOIpsN2mEG9InemZSAQhoyyTV4uT2T5ASZMjqvcxGdMSeFx30 VnrsqA2ug7igy//13MRhbw== 0001193125-07-151818.txt : 20070709 0001193125-07-151818.hdr.sgml : 20070709 20070709170808 ACCESSION NUMBER: 0001193125-07-151818 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070702 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070709 DATE AS OF CHANGE: 20070709 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: 07970060 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

July 2, 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)

383 Colorow Drive

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 1.01 Entry into a Material Definitive Agreement.

On July 2, 2007, NPS Pharmaceuticals and Nycomed Danmark ApS, NPS’ partner for European commercialization of Preotact®, entered into a License Agreement which is intended to (i) expand the territory originally licensed to Nycomed under the Distribution and License Agreement entered into by the parties in April 2004, which we refer to as the “2004 License Agreement”, and (ii) amend certain rights and responsibilities of NPS and Nycomed, which were originally set forth in 2004 License Agreement. We refer to the new License Agreement in this report as the “Agreement.”

Under the Agreement, we grant to Nycomed the exclusive right to commercialize Preotact® in all non-U.S. territories, excluding Japan and Israel. The Agreement provides that upon regulatory approval of Preos in the U.S., Nycomed’s licensed rights in Canada and Mexico will revert back to NPS or its licensee for commercialization in the U.S. The Agreement contains milestone and royalty payment obligations which are identical to those under the 2004 License Agreement. Under the Agreement, Nycomed is only required to pay NPS royalties on product sales in the original territory under the 2004 License Agreement, which consists of all countries in the European Union, the Common Wealth of Independent States and Turkey. The Agreement provides for the assumption by Nycomed of (i) NPS’ manufacturing and supply obligations under the 2004 License Agreement for drug product and the pen injection device, and (ii) NPS’ patent prosecution and maintenance obligations under the 2004 License Agreement. The Agreement provides that Nycomed has until September 1, 2007 to notify NPS of its intent to assume all manufacturing and supply obligations for Preotact® in the territory. If Nycomed notifies NPS of its intent to assume such manufacturing and supply obligations by September 1, 2007, the license grant to Nycomed for the new territories under the Agreement will become permanent. If Nycomed fails to notify NPS of its intent to assume such manufacturing and supply obligations by September 1, 2007, the Agreement and the new license grants thereunder, with the exception of the license grant for Brazil, will terminate and the 2004 License Agreement will again become the operative license agreement between the parties. As part of the manufacturing transfer, Nycomed will pay NPS $11 million for a significant portion of the existing bulk drug supply. The Agreement contains other representations, warranties, covenants and indemnification obligations which are substantially similar to those in the 2004 License Agreement and customary for a transaction of this nature.

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

 

Item 8.01 Other Events.

On July 9, 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 July 9, 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: July 9, 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 Press Release

Exhibit 99.1

 

For Immediate Release      Contact: Brandi Simpson  
     Sr. Director, Investor Relations  
     NPS Pharmaceuticals, Inc.  
     (801) 583-4939  

NPS PHARMACEUTICALS EXPANDS AGREEMENT WITH EUROPEAN PARTNER NYCOMED TO

INCLUDE BROADER TERRITORY RIGHTS FOR PREOTACT®

Parsippany, NJ – July 9, 2007 – NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that the company and its partner for European commercialization of Preotact® (full-length parathyroid hormone [PTH 1-84]) (US trade name PREOS®), Nycomed, have entered an agreement expanding and amending rights and responsibilities under the Preotact license originally entered into in 2004. Under the new agreement, Nycomed will gain the right to commercialize Preotact in all ex-US territories, excluding Japan, for which NPS retains commercial rights, and Israel which is the subject of a pre-existing distribution agreement with Israel-based Neopharm, Ltd. Upon registration and approval in the United States, rights to Canada and Mexico will revert to NPS. The agreement provides for the transfer of manufacturing responsibility from NPS to Nycomed for drug supply in its territories. Additionally, the agreement grants NPS the right to monetize the royalty stream from Preotact sales. As part of the manufacturing transfer, Nycomed will pay NPS $11 million for a significant portion of the existing bulk drug supply. Additional financial details were not disclosed.

Tony Coles, M.D., president and CEO of NPS said, “This transaction does two important things. First, it provides for broader registration and commercialization of PREOS globally. Preotact has had a good launch in the European markets and appears to be well accepted by physicians and well tolerated by patients. Second, this transaction supports our strategy to consolidate operations. The transfer of non-US manufacturing responsibility allows us to focus our investment and efforts on advancing our late-stage compounds, PREOS and teduglutide.”

Hakan Bjorklund, Nycomed CEO stated, “This expanded agreement allows Nycomed to fully leverage the commercial capabilities and infrastructure we gained through the acquisition of ALTANA Pharma. The early experience with Preotact in the European markets has been encouraging and we look forward to continuing to build our global presence with a product as therapeutically important as Preotact.”

NPS developed Preotact and licensed European and CIS marketing rights to Nycomed in 2004. The drug was approved by the European Medicines Agency in 2006 for the treatment of osteoporosis in postmenopausal women at high risk of fractures and has been launched in most of the major European markets. Nycomed expects to complete the drug’s launch throughout the European Union this year.

About NPS Pharmaceuticals

NPS discovers and develops 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.

Cautionary Statement for the Purpose of the “Safe Harbor” Provisions of the Private Securities Litigation

Reform Act of 1995

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. Such risks and uncertainties include: The success of the commercialization of Preotact in Europe depends on Nycomed’s efforts and is beyond our control; for us to receive any significant royalty payments from Nycomed, they must devote adequate resources to marketing Preotact in Europe and achieve


market acceptance for the drug; manufacturing biological products such as Preotact is complex and no assurances can be provided that the transfer of Preotact manufacturing responsibility to Nycomed will occur in a timely manner or that Nycomed will be successful in securing commercial supply of Preotact in a timely manner or at all. All information in this press release is as of July 9, 2007, and we undertake no duty to update this information. A more complete description of the risks associated with our business 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 March 31, 2007.

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