0001104659-10-008038.txt : 20100219 0001104659-10-008038.hdr.sgml : 20100219 20100219070141 ACCESSION NUMBER: 0001104659-10-008038 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100219 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100219 DATE AS OF CHANGE: 20100219 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: 10618045 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 a10-4154_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): February 19, 2010

United Therapeutics Corporation

(Exact Name of Registrant as Specified in Charter)

Delaware
(State or Other
Jurisdiction of
Incorporation)

000-26301
(Commission
File Number)

52-1984749
(I.R.S. Employer
Identification Number)

1110 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On February 19, 2010, United Therapeutics Corporation issued a press release announcing that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso for the treatment of pulmonary arterial hypertension in the European Union. 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 19, 2010

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 19, 2010	By:	/s/ Paul A. Mahon
	Name:	Paul A. Mahon
	Title:	General Counsel

Exhibit Index

Exhibit No.		Description of Exhibit

99.1		Press release dated February 19, 2010

EX-99.1 2 a10-4154_1ex99d1.htm EX-99.1

Exhibit 99.1

For Immediate Release
Contact: Andrew Fisher
(202) 483-7000
Afisher@unither.com

UNITED THERAPEUTICS CORPORATION WITHDRAWS EUROPEAN MARKETING AUTHORIZATION APPLICATION FOR TYVASO FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION

Conference Call to be Held at 9:00 a.m. Eastern Time Today, February 19, 2010

Silver Spring, MD, February 19, 2010: United Therapeutics Corporation (NASDAQ: UTHR) announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.

United Therapeutics submitted its MAA for Tyvaso to the European Medicines Agency (EMA) in December 2008. The data included in the MAA is based upon clinical work performed from 2005 to 2007 by United Therapeutics’ wholly-owned subsidiary Lung Rx, LLC. The MAA was withdrawn following communication from the Committee for Medicinal Products for Human Use (CHMP) of the EMA citing a major objection. The major objection noted that findings of non-compliance with good clinical practices (GCP) at two clinical sites would preclude a recommendation by the EMA for approval of the MAA for Tyvaso.

“Notwithstanding the fact that the EMA’s major objection noted findings of non-compliance with good clinical practices, it is important to note that there were no major objections related to the safety or efficacy of Tyvaso” said Roger Jeffs, Ph.D., United Therapeutics’ President and Chief Operating Officer.

“Our revenue growth targets are unaffected by the withdrawal,” said Martine Rothblatt, Ph.D., United Therapeutics’ Chairman and Chief Executive Officer. “We have long based our growth targets on the estimated 30,000 diagnosed PAH patients in the US, including approximately 12,000 New York Heart Association Class III patients.”

Conference Call

We will host a half-hour teleconference on Friday, February 19, 2010, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing (888) 211-7449, with international callers dialing (913) 312-0961. A rebroadcast of the teleconference will be available for one week by dialing (888) 203-1112, with international callers dialing (719) 457-0820 and using access code 3784360.

This teleconference is also being webcast and can be accessed via our website at http://ir.unither.com/events.cfm.

About Tyvaso

Tyvaso is an inhaled medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. Tyvaso contains the same active ingredient (treprostinil) as Remodulin (treprostinil) Injection, which is also approved for the treatment of PAH. Tyvaso is marketed by United Therapeutics and its wholly-owned subsidiary, Lung Rx, LLC.

About United Therapeutics

United Therapeutics Corporation 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.

Forward-looking Statements

Statements included in this press release concerning the impact of the GCP shortcomings identified by the EMA, the benefits of Tyvaso for patients, the number of diagnosed US PAH patients, and our revenue growth targets are

“forward-looking statements” within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These 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 and 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, which could cause actual results to differ materially from anticipated results. We are providing this information as of February 19, 2010, 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. [uthr-g]

Tyvaso and Remodulin are registered trademarks of United Therapeutics Corporation.

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