Orphan Status for Insmed's Arikace

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The US Food and Drug Administration (:FDA) Office of Orphan Products Development recently granted orphan drug designation to Insmed Incorporated’s (INSM) 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 Cytokinetics Inc. (CYTK), Athersys Inc. (ATHX) and Array BioPharma Inc. (ARRY) look bettered positioned. While Cytokinetics and Athersys carry a Zacks Rank #1 (Strong Buy), Array carries a Zacks Rank #2 (Buy).

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