SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Apr 18, 2023 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent research across its development portfolio will be presented at the International Society for Heart and Lung Transplantation (ISHLT) 43rd Annual Meeting and Scientific Sessions in Denver, Colorado on April 19-22, 2023, and at the American Thoracic Society (ATS) International Conference in Washington, D.C. on May 19-24, 2023. At ATS, United Therapeutics will host an educational symposium on pulmonary hypertension associated with interstitial lung disease (PH-ILD) and is sponsoring the ATS 2023 Women’s Forum.
“Our posters and presentations at ISHLT 2023 will provide additional insight into outcomes associated with our ex-vivo lung perfusion program and initial detail into recent xenotransplant work in human preclinical models using our UHeart™ xenoheart,” noted Gil Golden, M.D., Ph.D., Chief Medical Officer at United Therapeutics. “In addition, we’re excited to present an overview of the phase 4 ARTISAN study that seeks to investigate a novel targeted treatment approach, aimed at the reduction of pathologically high mean pulmonary artery pressures through early and rapid parenteral treprostinil up-titration, potentially leading to improved right ventricular structure and function in patients with pulmonary arterial hypertension.”
“Following top line data last year, we’re looking forward to presenting additional data from the EXPEDITE study that demonstrated a short induction period with Remodulin could lead to more rapidly achieving an efficacious dose of Orenitram, as well as baseline data from the TETON studies of nebulized Tyvaso in patients with idiopathic pulmonary fibrosis,” said Andrew Nelsen, PharmD, Vice President, Global Medical Affairs at United Therapeutics. “We are also looking forward to presenting data from ongoing research into the often-overlooked geographic differences in access to care among PAH patients in the U.S.”
ISHLT posters and presentations include:
Poster Session 2. Cardiology, Thursday, April 20, 4:15 - 5:15 PM MT: THU-144 851 – ARTISAN: A Novel Study of Mean Pulmonary Artery Pressure-Targeted Approach with Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Pulmonary Arterial Hypertension. Presented by Raymond Benza, The Ohio State University.
Poster Session 3. Pulmonology, Friday, April 21, 5:00 - 6:00 PM MT: FRI-217 1233 – Utilization and Outcomes with Single Lung Transplantation Following Ex Vivo Lung Perfusion Using a Centralized Lung Evaluation System at a Dedicated Facility. Presented by Jorge Mallea, Mayo Clinic Florida.
Poster Session 3. Pulmonology, Friday, April 21, 5:00 - 6:00 PM MT: FRI-218 1234 – Comparison of Lung Utilization from NRP-DCD vs Non-NRP DCD Using EVLP. Presented by Sean Francois, Vanderbilt University Medical Center.
Session 93. A MIDSUMMER NIGHT'S DREAM: From Mitochondria to Xenotransplantation: Novel Research Coming to You!, Saturday, April 22, 11:45 - 11:55 AM MT: 203 – Two 10-Gene Modified Xenoheart Transplants into Brain Dead Decedents. Presented by Nader Moazami, NYU Langone Health.
Plenary 3. General Session III, Saturday, April 22, 9:50 - 10:15 AM MT: Xenotransplantation: The Future is Now. Presented by Robert Montgomery, NYU Langone Transplant Institute.
ATS posters and presentations include:
Mini Symposium, Monday May 22, 3:51 - 4:03 AM ET: B97 – Remodulin Induction Facilitates Rapid Achievement of Therapeutic Doses of Oral Treprostinil: Results from the EXPEDITE Study. Presented by John Kingrey, Integris Baptist Medical Center.
Rapid abstract poster discussion session, Sunday, May 21, 9:00 - 11:00 AM ET: A22/304 – Understanding Differences in Geographic Access to Care Among Patients Treated for Pulmonary Arterial Hypertension in the United States. Presented by Natalie West, United Therapeutics.
Thematic poster session, Sunday, May 21, 11:30 - 1:15 PM ET: A59/P766 – Preliminary Baseline Data from the TETON Phase 3 Clinical Trials of Inhaled Treprostinil in the Treatment of Idiopathic Pulmonary Fibrosis. Presented by Steven Nathan, INOVA Fairfax Hospital.
Thematic poster session, Monday, May 22, 11:30 - 1:15 PM ET: B57/P161 – Win Ratio Analysis of the FREEDOM-EV Trial - A Hierarchical Approach to Multiple Clinical Endpoints. Presented by James White, University of Rochester Medical Center.
Thematic poster session, Monday, May 22, 11:30 - 1:15 PM ET: B57/P168 – Assessing the Correlation Between Actigraphy Data and Clinical Measures: Insights From The ADAPT Registry. Presented by James Gagermeier, Loyola University Medical Center.
Thematic poster session, Monday, May 22, 11:30 - 1:15 PM ET: B57/P175 – Correlation of WHO Functional Class and Patient-Reported Outcome Measures in Adults with Pulmonary Arterial Hypertension. Presented by Karim El-Kersh, University of Nebraska Medical Center.
Thematic poster session, Monday, May 22, 11:30 - 1:15 PM ET: B59/P209 – Study Design of the Decentralized EVOLVE Study Evaluating Real-world Use of Next Generation Infusion Pumps to Deliver Parenteral Treprostinil in Patients with Pulmonary Arterial Hypertension. Presented by Margo Sketch, United Therapeutics.
Thematic poster session, Monday, May 22, 11:30 - 1:15 PM ET: B59/P215 – Dose-response Analyses of Treprostinil Inhalation Powder in PAH and Its Effect on 6MWD. Presented by Karim El-Kersh, University of Nebraska Medical Center.
Thematic poster session, Tuesday, May 23, 11:30 - 1:15 PM ET: C36/P898 – The PAH Patient Perspective: Factors Influencing Treatment Initiation with Inhaled Prostacyclin Therapy. Presented by Karim El-Kersh, University of Nebraska Medical Center.
Poster discussion session, Wednesday, May 24, 8:00 - 10:00 AM ET: D28/501 – A Novel Approach to Clinical Change Endpoints: A Win Ratio Analysis of the INCREASE Trial. Presented by Steven Nathan, INOVA Fairfax Hospital.
Poster discussion session, Wednesday, May 24, 8:00 - 10:00 AM ET: D28/505 – The Safety and Efficacy of Inhaled Treprostinil in Patients with PH-ILD on Supplemental Oxygen: A Post-hoc Analysis of the INCREASE Study. Presented by Sandeep Sahay, Houston Methodist Hospital.
Sponsored events at ATS include:
PH-ILD Reimagined: 2023 Updates in Disease State, Treatment, and Device Options, Sunday, May 21, 5:30 PM ET, featuring Jamie Rutland, West Coast Lung, Rutland Medical Group; Steven Nathan, INOVA Fairfax Hospital; and Colleen McEvoy, Washington University Physicians. The symposium will be held at the Renaissance Hotel Washington, DC Downtown, Potomac Ballroom, Salon 1-3.
The ATS 2023 Women’s Forum, Monday, May 27, 11:45 AM - 1:15 PM ET, featuring Refiloe, University of KwaZulu Natal, and Mina Gaga, Imperial College and the Royal Brompton Hospital.
About Orenitram® (treprostinil) Extended-Release Tablets
Indication
Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).
Important Safety Information for Orenitram
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Specific Populations
Please see Full Prescribing Information and Patient Information at www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).
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
Adverse Reactions
Drug Interactions
Specific Populations
Please see accompanying Full Prescribing Information for Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
About TYVASO® (treprostinil) Inhalation Solution and TYVASO DPI® (treprostinil) Inhalation Powder
INDICATION
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of:
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
DRUG INTERACTIONS/SPECIFIC POPULATIONS
ADVERSE REACTIONS
United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
You can learn more about what it means to be a PBC here: unither.com/PBC.
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 upcoming medical conference posters and presentations, our ARTISAN and TETON clinical studies, 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 April 18, 2023, 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.
REMODULIN, ORENITRAM, and TYVASO are registered trademarks of United Therapeutics Corporation.
UHEART is a trademark of United Therapeutics Corporation.
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