Under the deal, Zambon has made an upfront payment of €140m (£125m) to acquire Breath Therapeutics and its subsidiaries and the acquisition value could increase to €500m (£446m) based on the clinical outcomes of Breath Therapeutics.
Zambon CEO Roberto Tascione said: “I am proud to announce the acquisition of Breath Therapeutics. This important deal, the largest in our history, reinforces Zambon’s commitment to serve severe respiratory diseases, enhancing and broadening our offering to the healthcare system, and complements our late-stage pipeline.”
Based in Munich of Germany and Menlo Park of California, Breath Therapeutics is specialised in providing advanced and first-in-class inhalation therapies for severe respiratory diseases.
The company’s L‑CsA‑I drug candidate is a novel liposomal formulation of Cyclosporine A designed for inhaled administration with the drug-specific and investigational customised nebulizer from PARI.
Breath has started two global phase III trials, including Boston-1 and 2, in the US and Europe to assess L-CsA-I to treat Bronchiolitis Obliterans Syndrome (BOS), a severe progressive lung disease with no approved therapies.
The company secured orphan drug designation for L-CsA-I from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to treat BOS.
Breath secured €43.5m series A financing from European investor syndicate, including Sofinnova Partners, Gimv and Gilde Healthcare, in 2017. It used the funding for L-CsA-I’s global phase III trials to establish a full commercial-scale production for the drug and the device.
Zambon intends to reveal the data from the L-CsA-i phase III clinical trials in 2021 and plans to make it ready for commercialisation by 2023, subject to FDA and EMA regulatory approvals.
Breath Therapeutics CEO Jens Stegemann said: “In Zambon, an ethical company with a strong heritage of innovation and a genuine commitment to a patient-orientated approach, we have a partner who shares our vision and significantly strengthens our position through their infrastructure, expertise, and commitment to R&D.”