Barcelona, February 24, 2022.- On the eve of World Rare Disease Day, which is celebrated every February 28, the international pharmaceutical company Ferrer has reinforced its growing focus on vascular and interstitial lung diseases and neurological disorders, announcing today the signing of a distribution agreement with United Therapeutics Corporation (Nasdaq: UTHR), for the inhalation solution Tyvaso® (treprostinil), a drug-device combination pharmaceutical to treat WHO Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD)4.
According to Mario Rovirosa, CEO of Ferrer, "this is an important milestone for Ferrer, a B Corp company, whose objective is to offer the best possible solutions to underserved patients around the planet, promoting a new way of doing business and being in the world".
With this agreement, Ferrer has been designated as the exclusive distributor and marketer worldwide (except in the USA, Canada, Japan, China and Israel) of 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 are proud of our strong and long-standing relationship with Ferrer, and this distribution agreement has the potential to bring Tyvaso to PH-ILD patients in need around the world who currently have no other treatment options," said Michael Benkowitz, president and chief operating officer of United Therapeutics. "Having recently become a Benefit Corporation ourselves, we also applaud and share Ferrer's patient-oriented mission, emphasized by its recent certification as a B Corp."
The agreement leverages Ferrer's strong capabilities and expertise in the field of pulmonary, vascular and interstitial diseases to reinforce both companies' commitment to expand global access to the inhaled solution of treprostinil for the treatment of PH-ILD.
"Tyvaso fits perfectly with Ferrer's mission to provide transformative products in this challenging area and helps us strengthen our product portfolio for the coming years," added Oscar Pérez, Director of Corporate Marketing, Market Access and Business Development at Ferrer.
Ferrer is a long-time partner at United Therapeutics, responsible for providing global access to Remodulin® (treprostinil) injection, a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to reduce symptoms associated with exercise.
"We are confident that Ferrer is an excellent partner for the distribution of our treprostinil products worldwide and we are very pleased to expand our collaboration. Without Ferrer, patients outside of our core markets would not have access to these life-sustaining therapies," said Beth Rhodes, Global Vice President of Supply Chain and Alliance Management at United Therapeutics.
Upon signing, Ferrer made an initial payment to United Therapeutics, who will also receive a transfer price and a revenue share from future sales of this product by Ferrer.
Ferrer is now working with health authorities to determine the most appropriate pathway to obtain approval for this product (currently authorized only in the U.S.) for the treatment of PH-ILD in other territories.
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On pulmonary hypertension associated with interstitial lung disease3,5
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. The increase in fibrotic tissue in ILD prevents oxygenation and free exchange of gases between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with exercise, shortness of breath, and fatigue.
WHO Group 3 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 supplemental oxygen requirements, decreased quality of life, and poorer outcomes. It is estimated that PH affects approximately 5,000 patients with ILD in Spain6; 15% of patients with early-stage ILD and up to 86% of patients with more advanced 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 INCREASE Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, 16-Week, Parallel-Group Study evaluated inhaled treprostinil in patients with PH-ILD. This study showed that treatment with inhaled treprostinil improved exercise capacity, as evidenced by the improvement in 6-minute walking distance to the end of the 16-week treatment period. In addition, treatment with inhaled treprostinil was associated with a lower risk of clinical worsening compared to placebo, a reduction in NT-proBNP levels, and fewer exacerbations of underlying lung disease.
About Treprostinilo Ferrer, EFG 7 infusion solution
INDICATION
Treprostinil Ferrer is a prostacyclin analogue indicated for the treatment of idiopathic or hereditary pulmonary arterial hypertension (PAH) to improve exercise tolerance and disease symptoms in patients with New York Heart Association (NYHA) functional class III.
Please see the attached Technical Data Sheet for Treprostinilo Ferrer.
TYVASO and REMODULIN are registered trademarks of two prescription drugs of United Therapeutics Corporation.
References:
- 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.
- 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.
- 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.
- 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.
- 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.
- Estimated patient population based on epidemiological reports. Ferrer's analysis.
- TREPROSTINIL FERRER,® EFG solution for infusion [Summary of Objections]. Available in: https://cima.aemps.es/cima/pdfs/es/ft/83747/83747_ft.pdf
