-----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, A+vrlVi7SBlikCtIO6xl08aNklOpRxAaLWPmk5SUwg/LcburW6mT94m5CEIwFdnv aUvT7TEvBU+2x1SOPkt+rA== 0000950133-00-004818.txt : 20001211 0000950133-00-004818.hdr.sgml : 20001211 ACCESSION NUMBER: 0000950133-00-004818 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20001207 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20001208 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: SEC FILE NUMBER: 000-26301 FILM NUMBER: 785939 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 w42398ae8-k.txt UNITED THERAPEUTICS 1 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): December 7, 2000 United Therapeutics Corporation ------------------------------------------------------------- (Exact Name of Registrant as Specified in Charter) Delaware 0-26301 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 ------------------------------------------- 2 ITEM 5. OTHER EVENTS. On December 7, 2000, the Registrant issued a press release attached hereto as Exhibit 99 and incorporated herein. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. Exhibit No. Description of Exhibit - ----------- ---------------------- 99 Press release of December 7, 2000 3 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 (Registrant) Date: December 8, 2000 By: /s/ Fred T. Hadeed --------------------------- Name: Fred T. Hadeed Title: Chief Financial Officer 4 Exhibit Index Exhibit No. Description of Exhibit ----------- ----------------------- 99 Press release of December 7, 2000 EX-99 2 w42398aex99.txt PRESS RELEASE OF DECEMBER 7, 2000 1 For Immediate Release For Further Information Contact: Therese Fergo, 301-608-9292 Email Therese@unither.com UNITED THERAPEUTICS DISCONTINUES KETOTOP OSTEOARTHRITIS PROGRAM BASED ON PHASE 3 TRIAL RESULTS Silver Spring, MD, December 7, 2000: United Therapeutics (NASDAQ: UTHR) announced today that it has received the results from its Phase 3 study investigating the transdermal patch Ketotop for the treatment of osteoarthritis of the knee. While individual endpoints in the 500 patient study achieved statistical significance, the key clinical and regulatory endpoint related to pain reduction did not meet the company's expectations. Based on these results, United Therapeutics has decided to discontinue development of Ketotop which the Company had expected to launch in 2003 had the data been favorable. "While we're disappointed with the results of this study, Ketotop has never been a primary target product for us," said Martine Rothblatt, Chairman and CEO of United Therapeutics. "We remain committed to achieving approval and commercializing our lead drugs, UT-15 and Beraprost, as well as to further developing our next generation prostacyclin molecules and our broad iminosugar platform. Our pipeline remains robust, with our pulmonary hypertension product pending FDA approval, our intermittent claudication product halfway through its second Phase 3 trial, our critical limb ischemia product in Phase 2 and our hepatitis B product nearing Phase 1. In addition, we are reviewing a number of acquisition opportunities." United Therapeutics is a biotechnology company focused on combating cardiovascular, inflammatory and infectious diseases with unique therapeutic products. * * * -----END PRIVACY-ENHANCED MESSAGE-----