Ferrer Obtains the Distribution Rights for Treprostinil Inhalation Solution Including the Potential Indications for Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

28.05.2024 - 15:00:50

Business Wire India

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*) – a pharmaceutical drug-device combination product authorized for the treatment of WHO Group 3 Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), and for WHO Group 1 Pulmonary Arterial Hypertension (PAH).

Both companies have signed the distribution rights for two new potential indications of the molecule, Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), two rare diseases characterized by scarring of lungs which results in difficulty for patients to breathe, leading to poor quality of life and even death. Current available treatments for IPF and PPF have only been shown to slow disease progression, whereas treprostinil inhalation solution could potentially offer a new treatment option in these patients.

“The pulmonary vascular and interstitial lung diseases field is very important for us”, said Oscar Pérez, Chief Scientific and Business Development Officer at Ferrer. “Strengthening our partnership with United Therapeutics Corporation can advance our purpose of using business to fight for social justice through the delivery of new solutions for people, families and caregivers living with devastating diseases”.

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.

The announcement 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 IPF and PPF patients, if approved.

Treprostinil inhalation solution is currently being assessed in three Phase 3 clinical trials: two in IPF patients (with over 1.000 subjects combined), and one in PPF patients (with 698 subjects), with a 52-week follow-up and collectively covering a global study geography.

inhalation solution is a prostacyclin mimetic indicated for the treatment of Pulmonary arterial hypertension (PAH; WHO Group 1) and Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). Tyvaso® for PH-ILD is currently authorized in the US, Israel, Chile, Dominican Republic, and Argentina, and under regulatory review in Japan, and for WHO Group 1 Pulmonary Arterial Hypertension (PAH), currently authorized in the US, Israel, Argentina, Colombia, Japan, and Dominican Republic. Regarding the registration of Tyvaso® (treprostinil) inhalation solution for the treatment of PH-ILD, Ferrer has just obtained the marketing authorization in Chile and Dominican Republic and will focus on obtaining it in the United Kingdom as well. Further assessment of Tyvaso® PH-ILD for the European Union will continue.