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 |
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000-26301 |
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52-1984749 |
(State or Other |
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(Commission |
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(I.R.S. Employer |
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Identification Number) |
Incorporation) |
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1040 Spring Street |
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Silver Spring, MD |
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20910 |
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(Zip Code) |
Registrants 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. |
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Description of Exhibit |
99.1 |
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Press release dated June 15, 2015 |
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.
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UNITED THERAPEUTICS CORPORATION | |
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Dated: June 15, 2015 |
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By: |
/s/ Paul A. Mahon |
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Name: |
Paul A. Mahon |
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Title: |
General Counsel |
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. Watsons 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 Watsons 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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