The US Food and Drug Administration (FDA) Office of Orphan
Products Development recently granted orphan drug designation to
) candidate, Arikace for the treatment of infections caused by
non-tuberculous mycobacteria (NTM).
Currently there is no approved therapy for NTM lung infection
in the US. Insmed is also looking for orphan drug designation of
the candidate in the EU.
Insmed is currently conducting a phase II study in the US and
Canada on Arikace in patients suffering from NTM lung infection.
Insmed expects results from the phase II study by the end of this
year. The company also plans to initiate a limited compassionate
use program on the candidate in the second half of this year.
On approval, Insmed initially plans to market the candidate in
the US and then in the EU and Canada.
Moreover, Arikace is also under phase III development for the
treatment of pseudomonas aeruginosa lung infections in patients
suffering from cystic fibrosis (CF). Insmed expects results from
the study soon. Arikace enjoys orphan drug designation for this
indication both in the US 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 the end of 2014.
Insmed, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Meanwhile, other biopharma stocks such as
Array BioPharma Inc.
) look bettered positioned. While Cytokinetics and Athersys carry
a Zacks Rank #1 (Strong Buy), Array carries a Zacks Rank #2
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