Insmed
Incorporated INSM, 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.
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