Form 8-K/A UNITED THERAPEUTICS Corp For: Sep 27
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
(Amendment No. 1)
CURRENT REPORT
Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 27, 2016
United Therapeutics Corporation
(Exact Name of Registrant as Specified in its 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 |
Jurisdiction of |
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File Number) |
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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 |
(Address of Principal Executive Offices) |
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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.
This Amendment No. 1 to the Form 8-K originally filed by United Therapeutics Corporation (the Company) with the Securities and Exchange Commission on September 27, 2016 (the Form 8-K), is being filed in order to correct errors contained in the updated product pipeline filed as Exhibit 99.1 to the Form 8-K. The sole corrections are to replace 2019 with 10,000 under the column Target U.S. Patient Population Size for the Tysuberprost pipeline product, and to correct typographical errors in the Tysuberprost and dinutuximab product names. The Companys updated product pipeline chart, showing these corrections, is attached as Exhibit 99.1 to this Amendment. No other changes have been made to the Form 8-K.
The information contained in Item 7.01 to this Current Report on Form 8-K, and 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 |
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Description of Exhibit |
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99.1 |
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Updated Product Pipeline dated September 27, 2016 |
Forward-looking Statements
Statements included in this Current Report on Form 8-K 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 development of products within the Companys pipeline, anticipated timing of preclinical and clinical studies, regulatory filings and approvals, and related market opportunities. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results. 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. 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 September 27, 2016, and assume no obligation to update or revise the information contained in this Current Report on Form 8-K, whether as a result of new information, future events or any other reason.
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: September 27, 2016 |
By: |
/s/ Paul A. Mahon |
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Name: |
Paul A. Mahon |
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Title: |
General Counsel |
Exhibit 99.1
UNITED THERAPEUTICS CORPORATION
Updated Product Pipeline
September 27, 2016
Product |
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Mode of Delivery |
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Indication |
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Current Status |
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Target FDA |
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Our Territory |
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Target U.S. |
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RemoSynch |
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Continuous intravenous via implantable pump |
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WHO Group 1 pulmonary arterial hypertension (PAH) |
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NDA to be resubmitted early 2017 following expected FDA complete response letter, following PMA resubmission (anticipated Oct 2016). |
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2017 |
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United States, United Kingdom, Canada, France, Germany, Italy and Japan |
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6,000 |
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RemUnity |
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Continuous subcutaneous via pre-filled, semi-disposable pump |
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PAH |
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Pre-NDA |
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2018 |
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Worldwide |
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6,000 |
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Dinutuximab |
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Injection or infusion |
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Multiple GD2 expressing cancers |
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Phase II/III |
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2019-2023 for accel. approval and other reg. pathways |
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Worldwide |
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12,000 |
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RemoPro |
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Continuous subcutaneous |
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PAH |
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Pre-clinical |
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2019 |
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Worldwide |
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9,000 |
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OreniPlus |
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Oral |
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PAH |
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Phase IV |
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2019 |
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Worldwide |
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15,000 |
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Ex-Vivo Lung Perfusion |
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Pre-transplant service providing extended preservation and assessment of donor lungs |
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End-stage lung disease |
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Phase II |
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2019 |
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United States |
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8,000 |
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Tysuberprost |
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Oral (esuberaprost) |
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PAH |
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Phase III |
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2019 |
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North America, Europe, Mexico, South America, Egypt, India, South Africa and Australia |
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10,000 |
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Tyvaso-ILD |
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Inhaled |
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Pulmonary hypertension associated with idiopathic pulmonary fibrosis (WHO Group 3) |
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Phase III |
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2020 |
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Worldwide |
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27,500 |
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Aurora-GT |
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Intravenous injection |
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PAH |
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Phase II/III |
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2020 |
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United States |
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10,000 |
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RemoLiv |
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Continuous intravenous |
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Liver transplant tolerance |
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Phase III |
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2020 |
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Worldwide |
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5,000 |
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OreniLeft |
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Oral |
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Pulmonary hypertension associated with left ventricular diastolic dysfunction |
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Phase III |
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2021 |
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Worldwide |
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50,000 |
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Unexisome |
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Infusion |
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Bronchopulmonary dysplasia |
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Pre-clinical |
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2022 |
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Worldwide |
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12,000 |
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OreniCell |
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Oral |
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Reduce morbidity and mortality in patients with pulmonary hypertension associated with sickle cell disease |
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Phase II/III |
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2022 |
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Wordlwide |
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25,000 |
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Manufactured Organs |
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Transplant |
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End-stage organ failure |
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Pre-Clinical |
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2023 |
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Worldwide |
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> 30,000 |
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