Insmed Incorporated (INSM) recently announced about two important patent allowances in the U.S. and Europe for its lead candidate, Arikace.
The U.S. Patent and Trademark Office (:USPTO) is looking to grant Arikace U.S. Patent Application No. 13/666,420 (titled lipid-based compositions of anti-infectives for treating pulmonary infections and methods of use thereof), which will expire on Dec 5, 2026.
The European Patent Office is looking to grant EU Patent Application No. 03816990 (titled sustained release of anti-infectives) for Arikace, which will expire on Oct 29, 2023. The patent will be valid in any European Patent Office member state where the company chooses to validate the patent.
Both patents will cover an aerosol composition for the treatment of pulmonary infections, including pseudomonas aeruginosa and mycobacterial infections, along with other indications, based on Insmed’s novel, once-daily inhalation formulation comprising amikacin and liposomal delivery technology.
These new patents will further boost the existing global patent portfolio of Arikace.
We note that in Apr 2013, the U.S. Food and Drug Administration granted orphan drug status to Arikace for the treatment of infections caused by non-tuberculous mycobacteria (:NTM).
"Insmed is currently conducting a phase II study on Arikace in the U.S. and Canada in patients suffering from NTM lung infection. Insmed expects to report top-line results from the study by the end of the first quarter of 2014. The company also plans to initiate a limited compassionate use program on the candidate in the second half of 2013.
If cleared by the regulatory bodies, Arikace would be the first approved inhaled antibiotic treatment for NTM lung infections.
Furthermore, Arikace is under phase III development for the treatment of pseudomonas aeruginosa (Pa) lung infections in patients suffering from cystic fibrosis (CF).
In Jul 2013, Insmed reported encouraging results from a phase III study on Arikace for the treatment of Pa in CF patients, when compared to Novartis’ (NVS) TOBI (tobramycin inhalation solution).
Insmed expects additional results from the study in the second half of this year. Arikace enjoys orphan drug status for this indication both in the U.S. and the EU. The company is currently enrolling patients for a two-year open-label extension study on Arikace for the same indication. The extension study is expected to be completed by mid 2015."