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Insmed Incorporated Announces Lifting of Clinical Hold by U.S. Food and Drug Administration on ARIKACE® in Cystic Fibrosis Patients With Pseudomonas Lung Infections
Date:5/7/2012

MONMOUTH JUNCTION, N.J., May 7, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.

Insmed has reached agreement with FDA on a revised CF clinical trial population consisting of adult patients who have chronic Pseudomonas lung infections and FEV-1 % predicted between 25% and 75%.  The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.  At the same time, the Company is evaluating possible next steps for the ARIKACE U.S. CF clinical program given the current progress and anticipated resource requirements of the ongoing ARIKACE CF (CLEAR-108) and U.S. non-tuberculous mycobacteria (NTM) clinical programs.

"We are pleased that FDA has lifted the clinical hold on the ARIKACE studies in both CF and, as previously disclosed, in patients with NTM lung disease," said Timothy Whitten, President and CEO of Insmed.  "We believe that ARIKACE has the potential to be an important treatment option for CF patients who have Pseudomonas lung infections, and patients who have lung infections due to NTM."

As recently announced, Insmed has begun dosing patients in CLEAR-108, a European and Canadian registrational phase 3 clinical study of ARIKACE in CF patients, and is proceeding with CLEAR-110, a follow-on multi-cycle open-label study intended primarily to measure safety and tolerability for patients who complete CLEAR-108.  The Company also previously announced it is initiating a U.S. phase 2 clinical trial of ARIKACE in NTM. 

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Insmed Incorporated is a biopharmaceutical company focused on the developm
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