) 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
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
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
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
) 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.
Insmed currently carries a Zacks Rank #3 (Hold). Currently,
companies which look attractive include
Gilead Sciences Inc.
) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy),
GILEAD SCIENCES (GILD): Free Stock Analysis
INSMED INC (INSM): Free Stock Analysis Report
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