0001104659-15-045294.txt : 20150615 0001104659-15-045294.hdr.sgml : 20150615 20150615091451 ACCESSION NUMBER: 0001104659-15-045294 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150615 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150615 DATE AS OF CHANGE: 20150615 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: 15930359 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 a15-14106_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):  June 15, 2015

 

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 June 15, 2015, United Therapeutics Corporation issued the press release attached hereto as Exhibit 99.1, which is incorporated herein by reference.

 

Item 9.01.  Exhibits.

 

This information 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.

 

(d)  Exhibits

 

Exhibit No.

 

Description of Exhibit

99.1

 

Press release dated June 15, 2015

 

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: June 15, 2015

 

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 June 15, 2015

 

4


EX-99.1 2 a15-14106_1ex99d1.htm EX-99.1

Exhibit 99.1

 

For Immediate Release

For Further Information Contact:

James Edgemond at (301) 608-9292

Email: jedgemond@unither.com

 

United Therapeutics Corporation Receives Paragraph IV Notice Letter for Tyvaso

 

SILVER SPRING, MD, and RESEARCH TRIANGLE PARK, NC, June 15, 2015/PRNewswire/ — United Therapeutics Corporation (NASDAQ: UTHR) today announced receipt of a Paragraph IV Certification Notice Letter from Watson Laboratories, Inc. (Watson) advising that Watson has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting approval to market a generic version of Tyvaso® (treprostinil) Inhalation Solution.

 

In the Notice Letter, Watson states that it intends to market a generic version of Tyvaso® before the expiration of U.S. Patent No. 6,521,212, which expires in November 2018; U.S. Patent No. 6,756,033, which expires in November 2018; and U.S. Patent No. 8,497,393, which expires in December 2028. Watson’s Notice Letter states that the ANDA contains a Paragraph IV Certification alleging that these patents are not valid, not enforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Watson ANDA submission.

 

United Therapeutics intends to vigorously enforce its intellectual property rights relating to Tyvaso®.

 

United Therapeutics currently is reviewing the Notice Letter.  United Therapeutics has 45 days from receipt of the Notice Letter to commence a patent infringement lawsuit against Watson.  Such a lawsuit would automatically preclude the FDA from approving Watson’s ANDA for up to 30 months or until the issuance of a district court decision that is adverse to United Therapeutics, whichever occurs first.

 

About United Therapeutics

 

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions.

 

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, statements regarding the enforcement of our intellectual property rights.  These forward-looking statements are subject to certain risks and uncertainties and 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 June 15, 2015, 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 is a registered trademark of United Therapeutics Corporation.

 

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