The acquisition sees Germany-based Breath Therapeutics, a specialized biopharmaceutical company focused on developing inhalation therapies, becoming part of Zambon.
Breath Therapeutics’ drug candidate L-CsA-I, a liposomal formulation of cyclosporine A, is currently in two global Phase III trials, and will be added to Zambon’s drug portfolio through the agreement as well.
Zambon stated it expects the data from the Phase III trials of the drug in 2021 and will be commercialized by 2023, subject to approval.
The drug candidate is designed for inhaled administration for the treatment of bronchiolitis obliterans syndrome (BOS), a severe progressive lung disease that currently has no approved therapies. L-CsA-I has received an orphan drug designation for this treatment indication from the US Food and Drug Administration and European Medicines Agency.
BOS is a rapidly progressive disease that leads to respiratory failure and death within one to two years after diagnosis, according to Breath Therapeutics.
The disease commonly affects patients who have received lung or stem cell transplantation and is also associated with autoimmune diseases. Approximately 50% of the patient population that receives a complex transplant, such as a lung or stem cell, will develop BOS within five years after transplantation.