-----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, ULaObAryUq9OkeoDsQohOadSBwSohDq0YocQMbQRveub/DMspXVcS3gBDeqigpcJ +3JxpuF91mS9EPrr2ZcFTw== 0000950133-03-003231.txt : 20030923 0000950133-03-003231.hdr.sgml : 20030923 20030923095717 ACCESSION NUMBER: 0000950133-03-003231 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030922 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030923 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UNITED THERAPEUTICS CORP CENTRAL INDEX KEY: 0001082554 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521984749 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26301 FILM NUMBER: 03905208 BUSINESS ADDRESS: STREET 1: 1110 SPRING ST CITY: SILVER SPRING STATE: MD ZIP: 20910 BUSINESS PHONE: 3016089292 MAIL ADDRESS: STREET 1: 1110 SPRING ST CITY: SILVER SPRING STATE: MD ZIP: 20910 8-K 1 w90135e8vk.htm FORM 8-K e8vk
 

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):         September 22, 2003

United Therapeutics Corporation
_______________________________________
(Exact Name of Registrant as Specified in Charter)

         
Delaware   000-26301   52-1984749
 
 
(State or Other   (Commission   (I.R.S. Employer
Jurisdiction of   File Number)   Identification Number)
Incorporation)        
     
1110 Spring Street    
Silver Spring, MD   20910
 
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code:

(301) 608-9292
———————————————

 

 

Item 5. Other Events.

     On September 22, 2003, United Therapeutics Corporation (the “Company”) issued a press release announcing that the French Regulatory Agency has recommended that Remodulin not be approved in France based on insufficient demonstration of clinical efficacy for the claimed indication. A copy of the press release is attached hereto and incorporated herein by this reference.

Item 7. Exhibits

     (c) Exhibits

     
Exhibit No.   Description of Exhibit
     
99.1   Press release dated September 22, 2003

 

 

SIGNATURE

     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.

       
     UNITED THERAPEUTICS CORPORATION
 
Dated: September 23, 2003  By: /s/ Paul A. Mahon      
     Name: Paul A. Mahon
     Title: General Counsel

 

 

EXHIBIT INDEX

     
Exhibit No.   Description of Exhibit
     
99.1   Press Release dated September 22, 2003

  EX-99.1 3 w90135exv99w1.htm EXHIBIT 99.1 exv99w1

 

EXHIBIT 99.1

For Immediate Release
For Further Information Contact:
Andrew Fisher at (301) 608-9292
Email: Afisher@unither.com

EUROPEAN APPROVAL OF REMODULIN DELAYED

Research Triangle Park, NC, September 22, 2003: United Therapeutics Corporation (NASDAQ:UTHR) announced today that it has been informed that the General Commission of the French Regulatory Agency has recommended that Remodulin not be approved in France based on insufficient demonstration of clinical efficacy for the claimed indication.

“We remain firmly committed to gaining marketing approval in Europe and will respond once we have received formal notice,” said Roger A. Jeffs, Ph.D., President and Chief Operating Officer of United Therapeutics. “We have a range of options available to us, including providing additional data, seeking revised labeling, and withdrawing the application in France in order to file in another European Union country. While we do not expect regulatory approval in Europe in the near term, we do expect European ‘named patient’ revenues to continue given that we are continuing to pursue regulatory approval in Europe.”

United Therapeutics is a biotechnology company focused on combating chronic and life-threatening cardiovascular, infectious and oncological diseases with unique therapeutic products.

In addition to historical information, this press release contains forward-looking statements about expectations regarding marketing approval for Remodulin in Europe and for continuing Remodulin ‘named patient’ revenue which are based on United Therapeutics’ beliefs and expectations as to future outcomes. These expectations are subject to risks and uncertainties such as those described in United Therapeutics’ periodic reports filed with the Securities and Exchange Commission which may cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in United Therapeutics’ periodic reports and documents filed with the Securities and Exchange Commission, including the company’s most recent Form 10-K and Form 10-Q,. United Therapeutics is providing this information as of September 22, 2003 and undertakes no obligation to publicly update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

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