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ARIKACE Meets Primary Endpoint Of Non-Inferiority To TOBI In Phase 3 Clinical Trial In Europe And Canada To Treat Pseudomonas Aeruginosa In Cystic Fibrosis Patients

“Cystic fibrosis patients chronically infected with Pseudomonas aeruginosa are among the most heavily burdened patients when it comes to the number, frequency and types of treatments they need to take on a daily basis. The data from this study suggest that once-daily treatment with ARIKACE may provide a safe, effective and more convenient alternative to twice-daily TOBI treatment,” stated Diana Bilton, MD, Director of Adult CF Centre at the Royal Brompton Hospital in London, and the Principal Investigator of the study. “The hope of a once-daily treatment offers encouragement to cystic fibrosis patients suffering with Pseudomonas aeruginosa lung infections.”

“We are very pleased with the results ARIKACE achieved in our Phase 3 trial and our attention now turns to preparing for regulatory filings with the EMA and Health Canada, which we expect to make during the first half of 2014,” said Will Lewis, President and Chief Executive Officer of Insmed.

“We appreciate the support of the Cystic Fibrosis Foundation and the European Cystic Fibrosis Society, and thank our principal investigators and patients for their commitment to this study. We look forward to the opportunity to present the complete data set at an upcoming medical conference and to having it published in a peer-reviewed journal. More importantly, if approved by the EMA and Health Canada, we look forward to bringing ARIKACE to market in order to benefit the thousands of CF patients in need of an effective and convenient treatment for these chronic and often life-threatening Pseudomonas aeruginosa lung infections,” he added.

Two-Year Extension Study

Eligible patients from this Phase 3 trial were given the option to participate in a two-year, open-label safety study. Approximately 75% of eligible patients have consented to participate in this study. The Company expects to use data from this study as part of the regulatory submissions to the European and Canadian authorities.

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