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.
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via the proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
About PARI Pharma GmbH and eFlow® Technology
PARI is a global leader in aerosol delivery device development. PARI Pharma specializes in pharmaceutical licensing partnerships and offers a comprehensive portfolio of devices and services, including customizable eFlow Technology mesh nebulizers, advanced development and analytical expertise, as well as robust manufacturing and supply chain capabilities. eFlow Technology represents a versatile nebulizer platform delivering tailored aerosol performance for a wide range of drug classes. Drug-specific eFlow nebulizers are currently part of numerous clinical studies and are commercially available in several countries. For more information, visit our website or follow us on LinkedIn.
**Vespera® Nebulizer System is the proposed trade name for PARI's commercial eFlow® Nebulizer System. It is not approved in any indication. Vespera is a trademark of PARI Pharma GmbH.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to the impact of this patent, the expected timing for resubmission of the BLA and MAA submissions, our plan to continue pursuing additional intellectual property protection, and the planned name under which the proprietary eFlow® Nebulizer System is to be commercially marketed for use with MOLBREEVI following approval. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
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Media and Investor Relations Contact
Savara Inc.
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