Zambon, a multinational pharmaceutical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives, announces the acquisition of Breath Therapeutics and its subsidiaries for € 140 million (up to total € 500 million subject to regulatory and sales milestones). The combination will improve both companies’ ability to better serve patients and healthcare professionals in severe respiratory diseases, as well as accelerate the commercialization of these important new therapies.
Breath Therapeutics (BREATH), based in Munich, Germany and Menlo Park, California, US, is a biopharmaceutical company specializing in advanced and first-in-class inhalation therapies for severe respiratory diseases with high unmet medical need. BREATH’s drug candidate is L‑CsA‑i, a novel proprietary liposomal formulation of Cyclosporine A, designed for inhaled administration with the drug-specific, investigational customized nebulizer from PARI. BREATH initiated two global phase III trials (BOSTON-1 and -2) in the US and Europe to evaluate L-CsA-i for the treatment of Bronchiolitis Obliterans Syndrome (BOS), a severe progressive lung disease with no approved therapies. It is estimated that there are over 30,000 people affected by BOS.
L-CsA-i has received orphan drug designation for the treatment of BOS from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), reflecting the high unmet need in addressing this disease. With financing in 2017 from its strong European investor syndicate, which includes Sofinnova Partners, Gimv and Gilde Healthcare, the BREATH team led L-CsA-i into global phase III trials, established a full commercial scale production for the drug and the device, and initiated commercial activities to prepare for and support future product launch.
BOS is a rapidly progressive disease that usually leads to respiratory failure and death within one to two years after diagnosis. BOS is caused by an inflammatory process triggered by the immune system that irreversibly destroys the airways of the lungs. BOS most commonly affects people who have received lung or stem cell transplantation, although it is also associated with autoimmune disease and exposure to environmental contaminants. This disease is particularly devastating to those who have undergone complex transplants, as nearly 50 percent of that patient population develops BOS within five years after transplantation.