0001104659-21-016929.txt : 20210210 0001104659-21-016929.hdr.sgml : 20210210 20210210060140 ACCESSION NUMBER: 0001104659-21-016929 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210210 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210210 DATE AS OF CHANGE: 20210210 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: 21609095 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 tm215968d1_8k.htm FORM 8-K
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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 10, 2021

 

United Therapeutics Corporation

(Exact Name of Registrant as Specified in its 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:

 

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

 

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

 

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

 

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

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading symbol(s)   Name of each exchange on which
registered
Common Stock, par value $0.01 per share   UTHR   Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company      ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 8.01. Other Events.

 

On February 10, 2021, United Therapeutics Corporation issued a press release announcing the commercial launch of the Remunity® Pump for Remodulin®. The press release is attached as Exhibit 99.1 and is incorporated herein by reference.

 

REMUNITY and REMODULIN are registered trademarks of United Therapeutics Corporation.

 

Item 9.01. Exhibits

 

  (d)  Exhibits
       
  Exhibit No.   Description of Exhibit
       
  99.1   Press release dated February 10, 2021
  104   The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

 

 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 10, 2021 By: /s/ Paul A. Mahon
  Name: Paul A. Mahon
  Title: General Counsel

 

 3 

 

 EX-99.1 2 tm215968d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

For Immediate Release

 

UNITED THERAPEUTICS ANNOUNCES COMMERCIAL LAUNCH

OF THE REMUNITY® PUMP FOR REMODULIN®

 

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Wednesday, February 10, 2021: United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has launched commercial sales of the innovative Remunity® Pump for Remodulin® for patients with pulmonary arterial hypertension (PAH).

 

“We are excited to bring to market the first subcutaneous pump designed specifically for PAH patients,” said Beth Rhodes, Vice President, Global Supply Chain & Alliance Management at United Therapeutics. “Remunity is a small, discreet pump that delivers Remodulin in prefilled cassettes that are delivered directly to patients, offering significant improvements over current subcutaneous pumps.”

 

“The team at United Therapeutics have been relentless in their quest to improve the lives of patients with PAH. The Remunity Pump is the next step in their critical mission. Everyone at DEKA is extremely proud to be launching our innovative delivery technology with United Therapeutics,” said Dean Kamen, Founder and President of DEKA. “While the COVID-19 pandemic has been devastating to all of us, the DEKA team has never forgotten that the PAH community is particularly vulnerable. This stark reality, along with the unwavering commitment by the UT team, has continued to energize us to reach this significant goal. We are confident that the Remunity Pump, particularly with cassettes prefilled with Remodulin, has the potential to improve the lives of the patients who depend on United Therapeutics.”

 

The Remunity Pump was initially cleared by the FDA in May 2019 with instructions for patient filling. An additional 510(k) clearance in February 2020 enables cassettes to be prefilled with Remodulin by contracted specialty pharmacies in order to improve convenience for patients.

 

About PAH

 

Pulmonary arterial hypertension (PAH) is life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly in afflicted patients. PAH is a serious, progressive disease for which there is no cure.

 

About the Remunity® Pump for Remodulin®

 

Developed in conjunction with DEKA Research and Development Corporation, Remunity is a discreet, subcutaneous delivery system designed for adults (age 22 years and greater) with pulmonary arterial hypertension (PAH). The cassettes, which contain enough drug for up to three days (72 hours), arrive from the specialty pharmacy prefilled, eliminating the need for the patient to mix or fill. Remunity is small, water resistant, and programmed using a wireless remote making it safe and simple to use. More information on Remunity can be found at https://youtu.be/Er40Fb-rqq8.

 

Indication

 

The Remunity® Pump for Remodulin® (treprostinil) Injection is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years of age).

 

Important Safety Information for Remunity

 

Warnings and Cautions

 

Do not use the system outside the conditions listed in the User Guide. Retain the User Guide for future reference. Refer to the User Guide for all warnings and cautions. Failure to comply with the following warnings and cautions may result in harm.

 

   

 

 

Limited to use with Remodulin. Only Remunity cassettes may be used with the Remunity pump. Remunity pump is for use only with FDA-cleared infusion sets: Medtronic Quick-set Infusion Set (MMT-392, MMT-393), Medtronic Silhouette Infusion Set (MMT-373), and Smiths Medical Cleo 90 Infusion Set (21-7230-24, 21-7220-24).

 

Do not use disposables from previously opened or damaged sterile packaging, damaged disposable components, or expired sterile components. Discontinue use of the remote and switch to the spare remote in the event the remote fails to operate. The use of cables, batteries, and battery chargers other than those provided or specified may result in increased emission or decreased immunity of the Remunity pump infusion system. Do not disconnect the pump from the cassette while the cassette is connected to the catheter. Avoid exposure of your pump and cassette to temperatures below 41˚F (5˚C) or above 104˚F (40˚C). The pump may affect nearby electrical and electronic devices, including medical devices, cell phones, Bluetooth devices, RFID readers, Wi-Fi equipment, and strong magnetic fields causing these devices to operate abnormally or to stop functioning. Do not open, crush, heat above 140°F (60°C), or incinerate the pump battery or remote, as doing so can lead to fire or rapid spreading of fire resulting in harm. This system supports flow rates between 16 μL/h and 225 μL/h. If your flow rate is outside this range, discuss with your healthcare practitioner.

 

Prescription Information

 

Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. Use of this device without the training and supervision of a healthcare practitioner may lead to errors that result in harm.

 

REMUISIhcpOct19

 

See the Remunity Pump for Remodulin (treprostinil) Injection Pharmacy-Filled User Guide for further detailed important safety information including warnings, cautions, and instructions on how to properly use the system.

 

For further information, please call United Therapeutics Corp. at 1-877-864-8437.

 

The Remunity Pump for Remodulin (treprostinil) Injection is manufactured for United Therapeutics Corp.

 

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

 

About Remodulin® (treprostinil) Injection

 

Indication

 

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

 

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

 

Important Safety Information for Remodulin

 

Warnings and Precautions

 

•Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.

•Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.

•Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.

 

  2 

 

 

•Remodulin is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.

•Remodulin inhibits platelet aggregation and increases the risk of bleeding.

 

Adverse Reactions

 

•In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache (27% vs. 23%), diarrhea (25% vs. 16%), nausea (22% vs. 18%), rash (14% vs. 11%), jaw pain (13% vs. 5%), vasodilatation (11% vs. 5%), edema (9% vs. 3%), and hypotension (4% vs. 2%).

 

Drug Interactions

 

•Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

 

Specific Populations

 

•In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.

•Safety and effectiveness of Remodulin in pediatric patients have not been established.

•It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.

•There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.

 

REMISIhcpOct19

 

Please see accompanying Full Prescribing Information for Remodulin.

 

For additional information, visit www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

 

About United Therapeutics

 

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture, and our bioinformatics leadership. We also believe that our determination to be responsible citizens – having a positive impact on patients, the environment, and society – will sustain our success in the long term.

 

Through our wholly owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company.

 

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 relating to the commercialization and use of the Remodulin Pump, our ability to create value and sustain our success in the long-term, as well as our efforts to develop technologies that either delay the need for transplantable organs or expand the supply of transplantable organs. 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 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 February 10, 2021 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.

 

  3 

 

 

REMODULIN and REMUNITY are registered trademarks of United Therapeutics Corporation.

 

For Further Information Contact:

Dewey Steadman at (202) 919-4097

Email: ir@unither.com

 

*            *            *

 

  4 

 

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Cover
Feb. 10, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 10, 2021
Entity File Number 000-26301
Entity Registrant Name United Therapeutics Corporation
Entity Central Index Key 0001082554
Entity Tax Identification Number 52-1984749
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 1040 Spring Street
Entity Address, City or Town Silver Spring
Entity Address, State or Province MD
Entity Address, Postal Zip Code 20910
City Area Code 301
Local Phone Number 608-9292
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.01 per share
Trading Symbol UTHR
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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