Breath Therapeutics' inhalation drug aims to be the first-in-class therapy for Bronchiolitis Obliterans Syndrome approved by the FDA
Italian pharmaceutical company Zambon has acquired Breath Therapeutics, a biopharmaceutical firm which develops innovative inhalation therapy, in a deal worth $156m.
The agreement will improve both companies’ ability to better serve patients with severe respiratory diseases and healthcare professionals, as well as accelerate the commercialisation capabilities of the treatment.
Based in Germany and the US, Breath Therapeutics develops inhalation therapies for the treatment of Bronchiolitis Obliterans Syndrome (BOS) – a severe progressive lung disease.
Zambon CEO Roberto Tascione said: “This important deal, the largest in our history, reinforces Zambon’s commitment to serve severe respiratory diseases, enhances and broadens our offering to the healthcare system, and complements our late-stage pipeline.
“Bronchiolitis Obliterans Syndrome is an incredibly debilitating condition.
“Through the combination of our geographic footprint, research and development infrastructure and relationships with scientific communities, we are well-positioned to accelerate the development of an important new potential treatment.
“We also have the expertise in respiratory and the commercial capabilities to bring the product to patients and doctors as soon as possible.”
Breath Therapeutics targets 2023 commercialisation for inhalation therapy
Breath Therapeutics’ drug candidate, Liposomal Cyclosporine A for Inhalation (L-CsA-i), received orphan drug designation – special status given to a drug developed to treat a rare disease or condition upon request of a sponsor.
BOS, also known as popcorn lung, is caused by inflammation triggered by the immune system that irreversibly destroys the airways of the lungs, which usually leads to respiratory failure and death within one to two years after diagnosis.
It most commonly affects people who have received lung or stem cell transplantation, although it is also associated with autoimmune diseases and exposure to environmental contaminants.
L-CsA-i has also received European Medicines Agency (EMA) support, which reflects the unmet demand to address this disease and led to the launch of its global phase III trials earlier this year to evaluate its effectiveness in individuals with BOS.
Zambon will use the data collected from these trials once they conclude in 2021, and is confident that the drug will be ready for commercialisation by 2023, subject to US Food and Drug Administration (FDA) and EMA regulatory approvals.
Breath Therapeutics CEO Jens Stegemann said: “We have established L-CsA-i as a promising therapy for the treatment of BOS, with the potential to impact patient lives.
“In Zambon, an ethical company with a strong heritage of innovation and a genuine commitment to a patient-orientated approach, we have a partner which shares our vision and significantly strengthens our position through its infrastructure, expertise and commitment to R&D.
“Together with the leading international lung transplantation centres participating in our Boston pivotal studies, we are now in an excellent position to achieve advances in the treatment of BOS.”