) completed patient enrollment in the randomized, placebo
controlled phase II study on its lead candidate, Arikace. The
study is evaluating Arikace for treating patients suffering from
recalcitrant nontuberculous mycobacterial (NTM) lung disease in
the U.S. and Canada.
Measurement of the change in the mycobacterial density
semi-quantitatively on a seven-point scale from baseline (day
one) to the end of the randomized portion of the trial on day 84
is the primary efficacy endpoint of the study. Insmed expects to
report top-line results from the study by the end of the first
quarter of 2014.
The U.S. Food and Drug Administration (FDA) granted qualified
infectious disease product and fast track designations to Arikace
for the treatment of NTM lung infections. Additionally, in Apr
2013, the FDA rendered orphan drug designation to Arikace for
Insmed has also started the Scientific Advice Working Party
procedure with the European Medicines Agency (EMA) relating to
Arikace for NTM lung disease. Discussions between the EMA and
Insmed are expected by year end.
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). Detailed data from the
study is expected to be presented at a medical conference by Dec
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 intends to seek approval of the candidate in the CF
indication in Europe and Canada in the first half of next year.
Moreover, Insmed also has plans to seek U.S. approval for Arikace
in the CF and NTM indications.
Insmed currently carries a Zacks Rank #4 (Sell). Currently,
companies which look attractive include
AMAG Pharmaceuticals, Inc.
) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy),
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