Insmed Reports Issuance of Two Patents

Insmed Incorporated

, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, announces two important patent allowances in the U.S. and Europe that strengthen the Company's global patent portfolio. Insmed is focused on the development and commercialization of ARIKACE(R) (liposomal amikacin for inhalation) for at least two identified orphan patient populations: cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections and patients with non-tuberculous mycobacteria (NTM) lung infections. The U.S. Patent and Technology Office (USPTO) intends to grant U.S. Patent Application No. 13/666,420 for ARIKACE in a patent titled, "Lipid-based compositions of anti-infectives for treating pulmonary infections and methods of use thereof." Once granted, it will provide exclusivity at least through December 5, 2026. The new U.S. patent will cover an aerosolized composition of Insmed's novel, once-daily inhalation formulation comprising amikacin and liposomal delivery technology for the treatment of pulmonary infections, including Pseudomonas aeruginosa and mycobacterial infections, among others. In May 2010 and July 2012, the USPTO issued composition-of-matter patents covering the Company's liposomal amikacin for inhalation, with exclusivity extending until at least June 2025 and August 2028, respectively. The European Patent Office intends to grant EU Patent Application No. 03816990 for ARIKACE in a patent titled, "Sustained release of anti-infectives." Once granted, it will provide exclusivity at least through October 29, 2023 in any European Patent Office member state where Insmed chooses to validate the patent. This patent will provide protection for the use of ARIKACE's formulation comprising amikacin and liposomal delivery technology for the treatment of pulmonary infections in CF patients. Specifically, the allowed patent application includes claims relating to the use of the aforementioned formulation for treating Pseudomonas aeruginosa pulmonary infections, as well as certain mycobacterial infections among others. This patent allowance is in addition to the recent European Patent Office's issuance of EU patent No. 1909759 for ARIKACE that will provide exclusivity through at least July 19, 2026.