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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

ARIKACE for the Treatment of NTM

Insmed is currently enrolling patients in the U.S. and Canada in a Phase 2 clinical trial of LAI to treat NTM lung infections. Of the targeted enrollment of 100 patients, 81 patients have been enrolled in this study to date. The second regularly scheduled Data Safety Monitoring Board (DSMB) meeting was held on June 28th, 2013 and the DSMB again recommended proceeding with the study without modifications.

"NTM lung infection is a disease that is being recognized and diagnosed with increasing frequency in the U.S. and worldwide. The risk for NTM lung disease is especially high in women as they age beyond the sixth decade of life. Pulmonary and Infectious Disease physicians are seeing these patients in ever growing numbers. While therapy can be reasonably effective for some patients, it routinely entails multiple, potentially toxic and expensive medications that must be given over long periods of time. Sadly, for many other patients, current therapies are inadequate with few alternative treatment strategies available,” said Dr. David Griffith, Professor of Medicine, W.A and E. B. Moncrief Distinguished Professor The University of Texas Health Sciences Center and a co-Principal Investigator on the U.S. NTM study.

“Research in the area of NTM lung disease has been woefully underfunded with no major therapeutic advances in the last 20 years. The availability of a once-a-day product that can help reduce bacterial density in these patients would represent a major step forward in the treatment of this disease," added Dr. Griffith.

On June 28, 2013, ARIKACE was granted QIDP designation and Fast Track designation by the FDA for the “treatment of Non-Tuberculous Mycobacterial lung infections.” The QIDP designation for ARIKACE will enable Insmed to benefit from certain incentives for the development of new antibiotics, including potentially more frequent and ongoing dialogue with FDA, priority review, and if ARIKACE is ultimately approved by the FDA, a five-year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which was signed into law in July 2012 as part of the FDA Safety and Innovation Act, the fifth authorization of the Prescription Drug User Fee Act.

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