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Insmed Incorporated Begins Screening Patients For TARGET-NTM U.S. Clinical Trial Of ARIKACE® In Patients With Non-tuberculous Mycobacterial Lung Disease

MONMOUTH JUNCTION, N.J., May 23, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that it has begun screening patients for its U.S. phase 2 clinical trial, Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM), of ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.

There have been very few clinical trials to support current NTM treatment recommendations, and no new drugs have been assessed in randomized trials for NTM lung disease in many years.   Additionally, NTM remains a significantly under-diagnosed disease.  TARGET-NTM represents an opportunity to make significant advancement in the awareness and treatment of this debilitating chronic illness, according to Kenneth N. Olivier, M.D., M.P.H., Principal Investigator of the study and staff pulmonologist in the Laboratory of Clinical Infectious Diseases at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

"Current treatment for NTM lung disease requires lengthy multi-drug regimens that can be poorly tolerated and have limited efficacy, especially in patients with severe disease or in those who have failed prior treatment attempts," said David E. Griffith, M.D., lead author of the American Thoracic Society's and the Infectious Disease Society of America's diagnosis and treatment guidelines for NTM, and Professor of Medicine at the University of Texas Health Science Center at Tyler. "If effective, ARIKACE has the potential to significantly impact the current NTM treatment paradigm."  Dr. Griffith, along with Richard J Wallace, M.D., Professor of Medicine and Microbiology, also at the University of Texas Health Science Center at Tyler, are Co-Principal Investigators for the study.

NTM Increasingly Prevalent

According to a recent company sponsored patient chart study conducted by Clarity Pharma Research, approximately 50,000 patients suffering from NTM lung disease visited physician offices in the U.S. during 2011.  More than half of these patients were treated with antibiotics for NTM.   This reflects a much larger patient population than previous Insmed estimates.

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