-----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, Kx2aNNalvrssp45fO/Zxz1yDVdtIkoONDgtTsLLXEQoWfnIzb1oUcdAbLGk4RyS3 CgiaqmSFvWf3QwCLwvvJNw== 0001104659-11-004281.txt : 20110202 0001104659-11-004281.hdr.sgml : 20110202 20110202070024 ACCESSION NUMBER: 0001104659-11-004281 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110131 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110202 DATE AS OF CHANGE: 20110202 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: 11564842 BUSINESS ADDRESS: STREET 1: 1040 SPRING ST CITY: SILVER SPRING STATE: MD ZIP: 20910 BUSINESS PHONE: 3016089292 MAIL ADDRESS: STREET 1: 1040 SPRING ST CITY: SILVER SPRING STATE: MD ZIP: 20910 FORMER COMPANY: FORMER CONFORMED NAME: UNITED THERAPEUTICS CORP DATE OF NAME CHANGE: 19990324 8-K 1 a11-4926_18k.htm 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 31, 2011

 

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)

 

 

 

 

 

1040 Spring Street

 

 

Silver Spring, MD

 

20910

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (301) 608-9292

 

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:

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 7.01  Regulation FD Disclosure

 

On February 2, 2011, United Therapeutics Corporation issued a press release announcing that enrollment in its FREEDOM-M registration trial was completed on January 31, 2011. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information contained in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01  Exhibits.

 

(d)  Exhibits

 

 

 

 

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press release dated February 2, 2011

 

2



 

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: February 2, 2011

By:

/s/ Paul A. Mahon

 

Name:

Paul A. Mahon

 

Title:

General Counsel

 

3



 

Exhibit Index

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press release dated February 2, 2011

 

4


EX-99.1 2 a11-4926_1ex99d1.htm EX-99.1

Exhibit 99.1

 

For Immediate Release

For Further Information Contact:

Andrew Fisher at (202) 483-7000

Email: Afisher@unither.com

 

UNITED THERAPEUTICS CORPORATION

COMPLETES ENROLLMENT OF FREEDOM-M TRIAL

 

Silver Spring, MD, February 2, 2011: United Therapeutics Corporation (NASDAQ: UTHR) announced today that enrollment in its FREEDOM-M registration trial was completed on January 31, 2011.

 

FREEDOM-M is a 12-week, multi-center, international, double-blind, randomized, placebo-controlled study of a sustained release oral formulation of treprostinil diethanolamine in pulmonary arterial hypertension (PAH) patients not receiving any other approved PAH therapy.

 

The FREEDOM-M study enrolled 349 patients, compared to a target enrollment of 315 patients.  The primary endpoint of the trial is change in six-minute walk distance at Week 12 in the treatment group compared to placebo.

 

“We are excited to achieve this important milestone,” said Roger Jeffs, Ph.D., President and Chief Operating Officer of United Therapeutics. “PAH patients and physicians have long awaited an approved oral prostacyclin therapy for this disease, and this milestone brings us one step closer to that goal.”

 

United Therapeutics expects to unblind and announce preliminary analysis of the FREEDOM-M study results in mid-2011.

 

About United Therapeutics Corporation

 

United Therapeutics is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. [uthr-g]

 

Forward-looking Statements

 

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, our expectations on the timing of unblinding of the FREEDOM-M study and our belief that the FREEDOM-M study unblinding will bring us closer to the goal of achieving an approved oral prostacyclin therapy for PAH.  These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could 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 our periodic reports and documents filed with the Securities a nd Exchange Commission,

 



 

including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and current reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of February 2, 2011, and assume no obligation to 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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