Savara and PARI Granted a European Patent Covering the Drug-Device Combination of MOLBREEVI* Delivered Via the Proprietary eFlow Nebulizer System
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the European Patent Office (EPO) has issued patent No. 4 496 611 titled, “Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution.” The patent is jointly held by Savara and PARI and covers the combination of Savara’s investigational therapy, MOLBREEVI, and PARI’s investigational eFlow Nebulizer System that has been optimized for the delivery of MOLBREEVI.
“This patent covers our drug-device combination through March 2043,” said Matt Pauls, J.D., M.B.A, Chair and Chief Executive Officer, Savara. “With 10 years of Orphan Drug regulatory exclusivity upon EU approval, as well as our exclusive license with PARI, this patent strengthens the long-term protection of MOLBREEVI for the treatment of autoimmune PAP in Europe. As we prepare for a December resubmission of the MOLBREEVI BLA in the U.S. and 1Q 2026 MOLBREEVI MAA submissions in Europe and the U.K., we will continue to pursue additional intellectual property protection in Europe, the U.S., and other major markets.”
MOLBREEVI, delivered via the proprietary eFlow Nebulizer System, was granted Fast Track and Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA), Orphan Drug Designation by the FDA and by the European Medicines Agency (EMA), and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of autoimmune PAP. It is planned for the proprietary eFlow Nebulizer System to be commercially marketed for use with MOLBREEVI under the name Vespera Nebulizer System following approval.**
About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

