Tyvaso (treprostinil) / United Therapeutics Corp - LARVOL DELTA

7250: TYVASO DPI® (treprostinil inhalation powder): Clinical Pearls and Drug-Device Characteristics (CHEST 2024) - "Description: This event brings together renowned experts and experienced clinicians at the forefront of PAH and PH-ILD care and research. We aim to review clinical evidence related to inhaled prostacyclin therapy and discuss patient selection, side effect management, transitions between different formulations, and drug-device technical characteristics."

Clinical

LONG-TERM OUTCOMES AND DOSING IN THE BREEZE STUDY OPTIONAL EXTENSION PHASE (CHEST 2024) - P1 | "In patients with PAH, Tyvaso DPI was safe and well-tolerated. The persistent benefit on 6MWD may be attributed to the up-titrated dose over time, which has been seen in other studies of inhaled treprostinil, or alternatively may be associated with improved compliance. CLINICAL IMPLICATIONS: Tyvaso DPI is a safe and tolerable treatment option for patients with PAH that may provide long-term maintenance of clinical stability."

Cough • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

COPD associated pulmonary hypertension: A post hoc analysis of the PERFECT study. (PubMed, Pulm Circ) - "The PERFECT study, a randomized, controlled, double-blind study of inhaled treprostinil in patients with COPD and associated pulmonary hypertension (PH-COPD) was a negative trial that was terminated early...These analyses are post hoc, observational, and exploratory. The thresholds defining the spectrum of responders are preliminary and may require further refinement and validation in future studies."

Journal • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • NPPB

TETON-OLE: Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=792 | Enrolling by invitation | Sponsor: United Therapeutics | Trial primary completion date: Jun 2024 ➔ Jun 2026

Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

United Therapeutics Corporation Reports Second Quarter 2024 Financial Results (United Therapeutics Press Release) - "United Therapeutics Corporation...announced its financial results for the quarter ended June 30, 2024. Total revenues in the second quarter of 2024 grew 20 percent year-over-year to $714.9 million, compared to $596.5 million in the second quarter of 2023...Total Tyvaso revenues grew by 25 percent to $398.2 million in the second quarter of 2024, compared to $318.9 million in the second quarter of 2023. This growth was primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in commercial utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, price increases....Cost of sales, excluding share-based compensation.Cost of sales for the three months ended June 30, 2024 increased as compared to the same period in 2023, primarily due to an increase in Tyvaso DPI royalty expense."

Sales • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Respiratory Diseases

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=24 | Enrolling by invitation | Sponsor: Mayo Clinic | Trial completion date: Jun 2024 ➔ Oct 2024 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

UNITED THERAPEUTICS CORPORATION ANNOUNCES FULL ENROLLMENT OF THE TETON 2 STUDY OF INHALED TREPROSTINIL FOR THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (United Therapeutics Press Release) - "Top line data expected in the second half of 2025...United Therapeutics Corporation...announced full enrollment of the TETON 2study evaluating the use of Tyvaso (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF)....Patients in any of the TETON program studies may use nebulized Tyvaso alone as a monotherapy or in combination with one background therapy approved for the treatment of IPF or PPF. Enrollment in TETON 1 and TETON PPF is ongoing."

Enrollment closed • Enrollment status • P3 data: top line • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

TETON-2: Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=597 | Active, not recruiting | Sponsor: United Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Analyzing Design of a Phase 3 Trial for Inhaled Treprostinil (IPF Summit 2024) - "Synopsis • Exploring the scientific rationale behind inhaled Treprostinil • Phase 3 trial design and special considerations of inhaled candidate for evaluating the long-term safety and tolerability of Treprostinil"

P3 data

Inhaled Treprostinil in Pulmonary Hypertension Associated with COPD: PERFECT study results. (PubMed, Eur Respir J) - P3 | "The risk-benefit observations associated with iTRE in patients with PH-COPD did not support continuation of the PERFECT study. The results of this study do not support iTRE as a viable treatment option in patients with PH-COPD."

Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Ferrer Obtains the Distribution Rights for Treprostinil Inhalation Solution Including the Potential Indications for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (Businesswire) - "The international pharmaceutical BCorp company Ferrer continues to strengthen its focus on pulmonary vascular and interstitial lung diseases by announcing the expansion of its current distribution agreement with United Therapeutics Corporation (Nasdaq: UTHR) for Tyvaso (treprostinil inhalation solution)...Under the expanded agreement, Ferrer has been appointed as the exclusive, worldwide distributor (except for the US, Canada, Japan, China, and Israel), to make this therapeutic option available upon approval for the treatment of IPF and PPF and keep delivering transformative solutions to the patients in need."

Licensing / partnership • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

SAPPHIRE: Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: University of Florida | Trial completion date: Oct 2023 ➔ Jul 2025 | Trial primary completion date: Oct 2023 ➔ Jan 2025

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Sarcoidosis

A Phase 3, 2-part, Open-label, Multicenter Study to Evaluate the Safety, and Efficacy of Liposomal Treprostinil Inhalation Suspension (l606) in Subjects With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (ATS 2024) - " The study (NCT: 04691154) is enrolling patients ≥18 years who transitioned from nebulized Tyvaso or Tyvaso DPI to L606 ('Transition') with PAH or PH-ILD or added L606 to prostacyclin 'naïve' patients on ≤2 non-prostacyclin oral therapies in PAH subjects. Patients receiving stable doses of nebulized treprostinil successfully transitioned to L606 with no significant safety concerns and the addition of L606 to background oral therapy was also well tolerated. One patient experienced TEAEs consistent with known side effects of inhaled treprostinil, none were severe. The overall AE profile was mild to moderate and generally did not hinder patients' ability to titrate to higher doses as needed."

Clinical • P3 data • Acute Kidney Injury • Cardiovascular • Cough • Dysphonia • Hypertension • Interstitial Lung Disease • Nephrology • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Renal Disease • Respiratory Diseases

Pulmonary Carcinoid Tumorlets in Pulmonary Hypertension Associated With Pulmonary Fibrosis (ATS 2024) - "Patient was discharged home on increased sildenafil 40 mg every 8 hours and plans to start inhaled treprostinil (Tyvaso). doi:10. 1056/NEJM199210293271806"

Bronchiectasis • Carcinoid Tumor • Cardiovascular • Chronic Obstructive Pulmonary Disease • Fibrosis • Hypertension • Immunology • Oncology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Study Design and Rationale for the TETON-PPF Clinical Trial of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis (ATS 2024) - P3 | "Background use of pirfenidone or nintedanib is allowed... The prospectively designed TETON-PPF Phase 3 clinical trial is being performed in parallel with the TETON studies for IPF to avoid any delay in this potential treatment option becoming available for PPF patients, who currently have limited treatment options but a similar prognosis as IPF patients."

Clinical • Cardiovascular • Fibrosis • Hypertension • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

TETON Phase 3 Clinical Trials of Inhaled Treprostinil in the Treatment of Idiopathic Pulmonary Fibrosis: Annual Update of Preliminary Baseline Data (ATS 2024) - P3 | "Stable background use of pirfenidone or nintedanib is allowed... The prospectively designed TETON Phase 3 clinical trials aim to definitively explore the hypothesis around inhaled treprostinil in IPF and may offer a much-needed inhaled treatment option for this vulnerable patient population."

Clinical • P3 data • Cardiovascular • Fibrosis • Hypertension • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Metabolomic Signatures of Pulmonary Hypertension Associated With Interstitial Lung Disease: A Post-hoc Analysis of the INCREASE Study (ATS 2024) - "Many of the changes in the placebo group were absent in the inhaled treprostinil group, which largely involved markers for fatty acid oxidation and muscle metabolism, suggesting that inhaled treprostinil may stabilize metabolic profiles. Changes in muscle metabolism may be attributed to improved perfusion-metabolism matching within skeletal muscle due to improved pulmonary blood flow and oxygen delivery to muscles. One biomarker family that significantly decreased in the treprostinil group was fibrinopeptide A metabolites, which are linked to fibrin formation, thrombosis, and vascular inflammation, which may play a role in pulmonary vascular disease and interstitial lung disease."

Retrospective data • Cardiovascular • Hematological Disorders • Hypertension • Inflammation • Interstitial Lung Disease • Nephrology • Pulmonary Arterial Hypertension • Pulmonary Disease • Renal Disease • Respiratory Diseases • Thrombosis

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=24 | Enrolling by invitation | Sponsor: Mayo Clinic | N=18 ➔ 24

Enrollment change • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Sotatercept (Winrevair) for pulmonary arterial hypertension. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

UNITED THERAPEUTICS CORPORATION REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS (United Therapeutics Press Release) - "Total Tyvaso revenues grew by 56 percent to $372.5 million in the first quarter of 2024, compared to $238.4 million in the first quarter of 2023. This growth was primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in commercial utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, a price increase....The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold and, to a lesser extent, a price increase. The increase in Tyvaso DPI quantities sold was due to continued growth in the number of patients following the product's launch and, to a lesser extent, increased commercial utilization following the implementation of the Part D redesign under the Inflation Reduction Act."

Commercial • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=18 | Enrolling by invitation | Sponsor: Mayo Clinic | Recruiting ➔ Enrolling by invitation | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Enrollment status • Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at the American Thoracic Society 2024 International Conference (Businesswire) - "An annual update of the preliminary baseline data from the TETON phase 3 studies of inhaled treprostinil in idiopathic pulmonary fibrosis will be presented at a poster session...United Therapeutics Corporation...announced that recent research across its commercial and development portfolio will be presented at the American Thoracic Society (ATS) International Conference in San Diego on May 17-22, 2024."

Clinical protocol • P3 data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Respiratory Diseases

Inhaled treprostinil in patients with pulmonary hypertension associated with interstitial lung disease with less severe haemodynamics: a post hoc analysis of the INCREASE study. (PubMed, BMJ Open Respir Res) - "Treatment with iTre led to consistent benefits in clinical outcomes in patients with PH-ILD and less severe haemodynamics. Earlier treatment in less severe PH-ILD may lead to better exercise capacity long-term, however, the subgroup analyses in this post hoc study were underpowered and confirmation of these findings is needed."

Journal • Retrospective data • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • NPPB

Tyvaso: Newly added patent in Orange Book (Orange Book) - Expiry on Feb 3, 2042

Patent • Idiopathic Pulmonary Fibrosis

MannKind Corporation (NASDAQ:MNKD) Q4 2023 Earnings Call Transcript (Yahoo Finance) - "We finished a year in the strongest position we have been in, in terms of financial ability, as well as by selling the Tyvaso -- 1% of our Tyvaso royalty for $150 million upfront and $50 million in revenue milestones....Going back to the top of the table, you will see that Tyvaso DPI royalty revenue for the fourth quarter was $21 million, which is 132% increase versus 2022, the result of continued growth in use of Tyvaso DPI for patients suffering from PAH and PH-ILD."

Commercial • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Respiratory Diseases