Rare Daily Staff

Privately-held Italian pharmaceutical company Zambon will acquire Breath Therapeutics for $160 million in upfront cash and up to another $405 million based on specified regulatory and sales milestones.

The deal extends Zambon’s pipeline in severe respiratory diseases with the acquisition of Breath’s late stage drug candidate for the treatment of Bronchiolitis Obliterans syndrome (BOS), a severe progressive lung disease with no approved therapies that affects about 30,000 people globally.

“The acquisition of Breath and its phase 3 asset, L-CsA-i for the treatment of BOS, complements Zambon’s existing pipeline in severe respiratory diseases and its presence in USA, which includes the treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE), extending the company’s leadership in two rare respiratory conditions,” said Jens Stegemann, CEO of Breath Therapeutics.

BOS is caused by an inflammatory process triggered by the immune system that progresses rapidly and irreversibly destroys the airways of the lungs, leading 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 disease and exposure to environmental contaminants. This disease is particularly devastating to those who have undergone complex transplants, as Zambon says that nearly half of patients who have undergone complex transplants develop BOS within five years after transplantation.

“Bronchiolitis Obliterans Syndrome is an incredibly debilitating condition,” said Roberto Tascione, CEO of Zambon. “Through the combination of our geographic footprint, R&D infrastructure and relationships with the scientific communities, we are well positioned to accelerate the development of an important new potential treatment and have the expertise in respiratory and the commercial capabilities to bring the product to patients and doctors as soon as possible”

Breath, based in Munich Germany and Menlo Park, California, was launched two years ago with a $46 million series A financing round to develop and commercialize L-CsA-I, a novel proprietary liposomal formulation of cyclosporine A, designed for inhaled administration with a drug-specific, investigational customized nebulizer. The company initiated two phase 3 trials in the United States and Europe to evaluate L-CsA-i as a treatment for BOS.

Results from the clinical trials are expected in 2021 and Zambon expects the drug will be ready for commercialization by 2023. 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).

“This acquisition is aligned to our core values and our vision to innovate cure and care,” said Elena Zambon, president of Zambon. “We are a “113 year old startup company,” as I often say, with a strong heritage and tradition, aiming to enrich our pipeline with new relevant research projects to invest in the future for our patients and our people.”

Photo: Jens Stegemann, CEO of Breath Therapeutics.

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