Ferrer announces distribution agreement with United Therapeutics for treprostinil inhalation solution for pulmonary hypertension associated with interstitial lung disease
Barcelona, 24 February. In the run up to Rare Disease Day, which is held on 28 February, international pharmaceutical company, Ferrer, has strengthened its focus on pulmonary vascular and interstitial lung diseases, as well as neurological disorders, by announcing today the signing of a distribution agreement with United Therapeutics Corporation (Nasdaq: UTHR) for Tyvaso® (treprostinil) inhalation solution – a pharmaceutical drug-device combination product for the treatment of WHO Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD)4.
According to Mario Rovirosa, Ferrer’s Chief Executive Officer, “This is an important milestone for Ferrer, a B Corp company. As a company, we aim to deliver the best possible solutions to underserved patients around the globe by promoting a new way of doing business and approaching the world.”
Under the agreement, Ferrer has been appointed as the exclusive, worldwide distributor (except for the US, Canada, Japan, China and Israel), to commercialise this therapeutic option for the treatment of PH-ILD – a rare, serious and progressive disease without an approved treatment in Europe and many other parts of the world1-3.
“We’re proud of our strong and lasting relationship with Ferrer, and this distribution agreement has the potential to bring Tyvaso to PH-ILD patients in need worldwide, who currently have no other treatment options,” stated Michael Benkowitz, President and Chief Operating Officer, United Therapeutics. “Having recently converted into a public benefit corporation ourselves, we applaud and share Ferrer’s patient driven mission – underscored by its recent B Corp certification.”
The agreement leverages Ferrer’s strong capabilities and expertise in pulmonary vascular and interstitial lung diseases and underscores both companies’ commitment to expanding global access to treprostinil inhalation solution for the treatment of PH-ILD.
“Tyvaso is the perfect fit for Ferrer’s mission to create lasting change by bringing transformative products in this challenging field to market and strengthens our pipeline for the coming years”, added Oscar Pérez, Chief Business Development and Global Alliances Officer, Ferrer.
Ferrer is a long-term partner of United Therapeutics, responsible for providing global access to Remodulin® (treprostinil) Injection, a prostacyclin vasodilator for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to reduce symptoms associated with exercise.
“We’ve found Ferrer to be an excellent partner for the distribution of our treprostinil-based products around the world and are thrilled to expand our collaboration. Without Ferrer, patients outside of our core markets would not have access to these life-sustaining therapies.” commented Beth Rhodes, Vice President, Global Supply Chain and Alliance Management, United Therapeutics.
Upon signing, Ferrer made a down-payment to United Therapeutics, who will also receive a transfer price and revenue sharing on future sales of this product by Ferrer.
Ferrer is now working with health authorities to determine the appropriate regulatory pathway to obtain approval for this product (currently only authorised in the US) for the treatment of PH-ILD in other territories.
Interstitial lung disease (ILD) is a group of lung diseases that are characterized by marked scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with activity, labored breathing, and fatigue.
WHO Group 3 Pulmonary hypertension (PH) frequently complicates the course of patients with interstitial lung disease and is associated with worse functional status measured by exercise capacity, greater supplemental oxygen needs, decreased quality of life, and worse outcomes. PH is estimated to affect approximately 50,000 patients with ILD in Europe6, at least 15% of patients with early-stage ILD and up to 86% of patients with more severe ILD.
About TYVASO® (treprostinil) Inhalation Solution4
Treprostinil is a stable analogue of prostacyclin, which promotes direct vasodilation of pulmonary and systemic arterial vascular beds and inhibits platelet aggregation.
The phase 3, multicenter, randomized, double-blind, placebo-controlled, 16–week, parallel-group INCREASE study evaluated inhaled treprostinil in patients with PH-ILD. This study showed that treatment with inhaled treprostinil improved exercise capacity as shown by improvement in the 6-minute walk distance through the end of the 16-week treatment period. In addition, treatment with inhaled treprostinil was associated with a lower risk of clinical worsening than that with placebo, a reduction in NT-proBNP levels, and fewer exacerbations of underlying lung disease.
About Remodulin®, Solution for Infusion7
Remodulin is a prostacyclin analogue indicated for the treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) to improve exercise tolerance and symptoms of the disease in patients classified as New York Heart Association (NYHA) functional class III.
Please see accompanying Summary of Product Characteristics for Remodulin.
TYVASO and REMODULIN are registered trademarks of two prescription drugs of United Therapeutics Corporation.
1. Galiè N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016;37(1):67-119.
2. Nathan SD, Barbera JA, Gaine SP, Harari S, Martinez FJ, Olschewski H, et al. Pulmonary hypertension in chronic lung disease and hypoxia. Eur Respir J. 2019 Jan 24;53(1):1801914.
3. Behr J, Nathan SD. Pulmonary hypertension in interstitial lung disease: screening, diagnosis and treatment. Curr Opin Pulm Med. 2021 Sep 1;27(5):396-404.
4. Waxman A, Restrepo-Jaramillo R, Thenappan T, Ravichandran A, Engel P, Bajwa A, et al. Inhaled Treprostinil in Pulmonary Hypertension Due to Interstitial Lung Disease. N Engl J Med. 2021 Jan 28;384(4):325-334.
5. King CS, Shlobin OA. The trouble with group 3 pulmonary hypertension in interstitial lung disease: dilemmas in diagnosis and the conundrum of treatment. Chest. 2020;158(4):1651-1664.
6. Estimated patient populations based on epidemiological reports. Ferrer analysis.
7. REMODULIN®, Solution for Infusion [Summary of Product Characteristics]. Available at: https://mri.cts-mrp.eu/Human/Downloads/FR_H_0278_002_FinalSPC.pdf