Savara Announces European Patent Office (EPO) Intends to Grant a Patent for the Liquid Formulation of MOLBREEVI*
-- Once Granted, the Patent Will Provide Protection for MOLBREEVI in Europe Until March 2041 --
-- Savara Was Also Recently Granted a European Patent Covering the Investigational Drug-Device Combination of MOLBREEVI Delivered Via PARI's Proprietary eFlow® Nebulizer System --
Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the EPO notified the Company of its intention to grant a patent application covering the liquid formulation of MOLBREEVI, an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).
"The liquid formulation and drug-device patents will provide protection in Europe through March 2041 and March 2043, respectively, and strengthen the Company's intellectual property portfolio for MOLBREEVI, our potentially first-in-class therapy to treat autoimmune PAP," said Matt Pauls, J.D., M.B.A, Chair and Chief Executive Officer, Savara. "Additionally, upon approval in the EU, MOLBREEVI will have 10 years of Orphan Drug regulatory exclusivity. We expect to resubmit the MOLBREEVI BLA to the FDA this month and are preparing to submit the MAA submissions in the EU and the U.K. by the end of 1Q 2026."
MOLBREEVI, delivered via the proprietary eFlow® Nebulizer System, has been 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 U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of autoimmune PAP.
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.
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 the patents and the duration of protection, that MOLBREEVI is a potentially first-in-class therapy to treat autoimmune PAP, that MOLBREEVI will have 10 years of Orphan Drug regulatory exclusivity upon approval, and the expected timing for resubmission of the BLA and MAA submission. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251211393845/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
[email protected]