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Insmed Announces First Quarter 2012 Financial Results
Date:5/8/2012

MONMOUTH JUNCTION, N.J., May 8, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a biopharmaceutical company, today reported results for the first quarter ended March 31, 2012.

Key Recent Highlights:

  • U.S. Food and Drug Administration (FDA) lifted clinical hold on ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections;
  • Initiated dosing in CLinical Evaluation of ARIKACE phase 3 study (CLEAR-108) of ARIKACE for CF patients;
  • U.S. phase 2 clinical trial for ARIKACE in the non-tuberculous mycobacterial (NTM) lung disease indication on track to begin in mid-2012;
  • Commenced dosing for nine-month inhalation dog toxicity study.
  • "We are pleased FDA has lifted the clinical hold on ARIKACE in CF patients, and are excited about the important recent progress we have made with our ARIKACE development program," said Timothy Whitten, President and CEO of Insmed.  "Many of the trial sites for CLEAR-108 are up and running, including those in key European countries and we are also proceeding with this study in Canada.  We anticipate top-line efficacy and safety data in mid-2013.  In addition, we are working towards initiating our phase 2 U.S. clinical trial for ARIKACE in NTM patients in mid-2012." 

    "We are at a point of significant focused activity with our ARIKACE development program, and continue to believe that ARIKACE provides a late-stage, potentially highly differentiated opportunity, with significant global commercial potential in both CF and NTM," continued Mr. Whitten.  "Importantly, we believe our current cash position is sufficient to generate top-line data from CLEAR-108 and the randomized portion of the U.S. phase 2 clinical trial for ARIKACE in NTM."

    Financial Results:For the first quar
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    SOURCE Insmed Incorporated
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