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Insmed's ARIKACE® Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections
Date:6/10/2011

consistent results of improved lung function throughout all six cycles of this study," said Professor Minic.  "In addition, there were no unexpected adverse events associated with the longer term use of the drug.  Taken as a whole, these data indicate that ARIKACE has the potential, if approved, to be an important product for CF patients with Pseudomonas lung infections."  

ARIKACE also demonstrated statistically significant reduction from baseline in Pseudomonas aeruginosa density, including mucoid strains, which was sustained during the treatment and off-treatment periods of the six cycles.  The estimated change from baseline in Log10 CFU over time was -0.6 log (95% CI, -0.2 to -0.9 log; p=0.0030).  Mucoid strains of Pseudomonas are often difficult to suppress with antibiotics and play a significant role in progression of CF lung disease.  In addition, there was no significant shift in the minimum inhibitory concentration (MIC90) of ARIKACE against Pseudomonas over the course of the six cycles, which suggests a lack of resistance development during the study period.

"These results further strengthen the clinical data package Insmed is developing for ARIKACE in the treatment of CF patients," said Renu Gupta, M.D., Executive Vice President Development & Chief Medical Officer of Insmed.  "The data are also indicative of why we are so excited to begin our Phase 3 clinical program in the CF indication, which we expect to initiate in the second half of this year.  For potential registration of ARIKACE in the U.S., we intend to conduct a placebo-controlled clinical trial, and for European registration, we intend to conduct a trial that compares ARIKACE to Novartis Corporation's TOBI®.  Results from these studies are anticipated in the first half of 2013."

"We are pleased that the development of ARIKACE continues to proceed expeditiously," said Robert J.
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SOURCE Insmed Incorporated
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