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Ferrer acquires distribution rights for potential treatment in FPI and FPP

Ferrer logo on a glass door, with two professionals in the background out of focus in a laboratory or production environment.

Barcelona, 27 May 2024. Ferrer, a certified international B Corp pharmaceutical company, continues to strengthen its focus on lung, vascular and interstitial diseases by announcing the extension of its existing agreement with United Therapeutics Corporation (Nasdaq: UTHR) for the distribution of Tyvaso® (treprostinil inhalation solution*), a combination of medicine and medical device authorized for the treatment of pulmonary hypertension associated with interstitial lung disease (HP-EPI; WHO group 3) and pulmonary arterial hypertension (PAH; WHO group 1).

 

Both companies have signed a new agreement on the distribution rights of this drug as a potential treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). These two rare diseases are responsible for scarring the lungs leading to shortness of breath, worsening quality of life, and even death. The treatments available today for IPF and PPF have only been shown to slow the progression of the disease, while treprostinil inhalation solution could represent a new therapeutic option for patients living with them.

 

"The field of pulmonary vascular and interstitial diseases is very important to us," said Óscar Pérez, Chief Scientific and Business Development at Ferrer. "Strengthening our partnership with United Therapeutics Corporation means realizing our purpose of using the business to fight for social justice by offering new therapeutic solutions for individuals, their families and their caregivers living with serious illnesses."

 

The terms of the new agreement give Ferrer exclusive distribution rights to the new therapeutic option to make it available, upon approval, worldwide (except the U.S., Canada, Japan, China, and Israel) to treat IPF and PPF.

 

The collaboration benefits from Ferrer's capabilities and experience in the field of pulmonary, vascular and interstitial diseases and revalidates the commitment of both companies to continue offering transformative solutions to patients who need them, should the new indications be approved.

 

Currently, the inhaled solution of treprostinyl is being evaluated in three phase III clinical trials: two in patients with IPF (which has more than 1,000 patients in total) and one in patients with PPF (with 698 patients). The follow-up period is 52 weeks, and together, the three trials represent a global study.

 

 

* Tyvaso® (treprostinyl inhalation solution) is a prostacyclin mimetic and is licensed for use in HP-EPI in the U.S., Israel, Chile, the Dominican Republic, and Argentina, and is under regulatory review in Japan. As for the treatment of PAH, it is authorized in the USA, Israel, Argentina, Colombia, Japan, and the Dominican Republic. In terms of registration for the treatment of HP-EPI, Ferrer has just obtained authorization for its marketing in Chile and the Dominican Republic, and will seek to obtain it in the United Kingdom, as well as continue to evaluate it for the European Union.

 

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About Interstitial Lung Disease (ILD)

Interstitial lung disease (ILD) encompasses a group of lung diseases that are characterized by marked scarring or fibrosis of the bronchioles and alveolar sacs of the lungs.

 

About Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF) is a scarring disease of the lungs of unknown cause (idiopathic) and is the most common of the idiopathic interstitial pneumonias. IPF is characterized by the progressive loss of the lungs' ability to transfer oxygen to the blood. This disease can present with a wide range of symptoms, including shortness of breath and fatigue, ultimately resulting in respiratory failure and death. Although its precise causes are unknown, IPF rarely presents before the age of 50 and may be associated with smoking and certain genetic predispositions. In addition, some evidence suggests that gastroesophageal reflux (acid reflux or heartburn), certain viral infections, air pollution, and exposure to certain substances in the workplace may be risk factors for IPF. According to recent research, IPF is estimated to affect between 0.33 and 4.51 out of every 10,000 people worldwide with a severe prognosis and a median survival of 2 to 3 years if left untreated1.

 

About Progressive Pulmonary Fibrosis (PPF)

Progressive pulmonary fibrosis (PPF) is a process associated with a group of interstitial lung diseases (ILD) that present with progressive, self-sustaining fibrosis and show a similar course to idiopathic pulmonary fibrosis (IPF). PPF includes idiopathic interstitial pneumonias (other than IPF), autoimmune ILD, chronic hypersensitivity pneumonitis, and fibrotic PID related to environmental or occupational exposure. It is estimated that between 13% and 40% of patients with these PIDs will develop PPF2. Patients with PPF have decreased lung function, poor quality of life, and increased mortality despite routine treatments for underlying ILD. Estimates of median transplant-free survival and overall survival are approximately 2.9 years and 3.7 years, respectively3.4.

 

About Interstitial Lung Disease-Associated Pulmonary Hypertension (PH-ILD)

Pulmonary hypertension (PH) frequently complicates the outcome of patients with interstitial lung disease and is associated with poorer functional status, as measured by exercise capacity, increased need for supplemental oxygen, poorer quality of life, and outcome. It is estimated that PH affects at least 15% of patients with early-stage PID and can affect up to 86% of patients with more severe PID5.

 

References:

  1. Maher TM, Bendstrup E, Dron L, et al. Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res. 2021 Jul 7; 22(1):197.
  2. Olson AL, Patnaik P, Hartmann N, et al. Prevalence and incidence of chronic fibrosing interstitial lung diseases with a progressive phenotype in the United States estimated in a large claims database analysis. Adv Ther. 2021;38:4100-4114.
  3. Platenburg MGJP, van der Vis JJ, Grutters JC, van Moorsel CHM. Decreased survival and lung function in progressive pulmonary fibrosis. Medicine. 2023;59:296.
  4. Cottin V, Teague R, Nicholson L, et al. The burden of progressive-fibrosing interstitial lung disease. Front Med. 2022;9:799912.
  5. 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.