AUSTIN, Texas, May 8, 2017 /PRNewswire/ -- Savara Inc. (NASDAQ: SVRA), a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases, today announced the recent issuance of United States Patent No. 9,572,774 for "Dry Powder Vancomycin Compositions and Associated Methods" by the United States Patent and Trademark Office. The patent will provide key intellectual property protection in the U.S. for the AeroVanc program and will expire no earlier than 2032. This affords Savara important composition of matter protection for its AeroVanc program in the U.S., the largest market for the product, and is a key component of the Company's market protection strategy which also includes Orphan Drug and Qualified Infectious Disease Product protection.
Savara has also received a Notice of Allowance from the Canadian Intellectual Property Office for its Canadian Patent Application No. 2,836,643 entitled "Dry Powder Vancomycin Compositions and Associated Methods." This notice serves as official communication that the examination of the patent application has been successfully completed. Once issued, the patent will provide protection for AeroVanc in Canada until 2032. The Company also has corresponding patent applications for AeroVanc in different stages of prosecution in other key markets throughout the world.
The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) pulmonary infection in cystic fibrosis (CF) patients has continued to rise in the United States, and the infection has been associated with increased use of intravenous, or IV, antibiotics, increased hospitalizations, a faster decline of lung function, as well as shortened life-expectancy. Despite inhaled antibiotics being available to CF patients for over ten years to treat non-MRSA infections, there is no approved inhaled antibiotic for the treatment of MRSA in CF. AeroVanc is being developed to address this unmet medical need in CF.
In a randomized, double-blind, placebo-controlled Phase 2 study in CF patients with persistent MRSA infection, AeroVanc reduced MRSA density in sputum, and showed encouraging trends of improvement in lung function, and respiratory symptoms, as well as prolongation of the time to use of other antibiotics, with best responses in subjects under 21 years of age. Savara plans to initiate a pivotal Phase 3 study of AeroVanc for the treatment of MRSA in CF patients in the third quarter of 2017.
AeroVanc has been granted Orphan Drug Designation and Qualified Infectious Disease Product, or QIDP, status for the treatment of persistent MRSA lung infection in CF patients in the United States. The Orphan Drug Designation makes AeroVanc eligible for seven years of exclusivity from approval in the United States, and ten years of exclusivity in the European Union and the QIDP designation makes AeroVanc eligible for an additional five years of exclusivity in the United States.
Savara Inc. is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases. Savara's pipeline comprises AeroVanc, a Phase 3 ready inhaled vancomycin, Molgradex, a Phase 2/3 stage inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF and Aironite, an inhaled nebulized sodium nitrite solution to treat HFpEF. Savara's strategy involves expanding its pipeline of best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara's management team has significant experience in orphan drug development and pulmonary medicine, in identifying unmet needs, creating and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma)
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 regarding the potential future benefits of patent protection, the impact of AeroVanc use, the timing of our AeroVanc Phase 3 study and Savara's strategy and goals. 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such 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, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the results and actual timing of clinical studies for our product candidates, our actual ability to protect our patented technology, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs, the timing and ability of Savara to raise additional equity capital to fund continued operations; the ability to successfully develop Savara's product candidates, and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Risks and uncertainties facing Savara are described more fully in Savara's filings with the Securities and Exchange Commission including the Form 8-K filed on April 27, 2017, other filings on Form 8-K, the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and the Registration Statement on Form S-4 related to the Mast/Savara merger. 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.