Arikace Receives Orphan Drug Designation For Treating Infections Caused By Non-Tuberculous Mycobacteria

Insmed Incorporated

, a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that ARIKACE(R) , the Company's Iiposomal amikacin for inhalation, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of infections caused by non-tuberculous mycobacteria (NTM). Orphan drug designation provides certain exclusivity benefits, tax credits for certain research and a waiver of the New Drug Application user fee. According to a recent company-sponsored patient chart study conducted by Clarity Pharma Research, approximately 50,000 cases of NTM lung disease were treated by physicians in the U.S. during 2011. There is no current FDA-approved treatment for NTM lung infection. "The FDA's timely approval of our request for orphan drug designation for ARIKACE to treat non-tuberculous mycobacteria is a key milestone that supports our broader strategy for this potentially life-saving therapy," stated Will Lewis, President and Chief Executive Officer of Insmed. "NTM is a chronic, debilitating disease, and currently available treatments have shown limited efficacy and tolerability. We continue to enroll patients in our phase 2 clinical trial of ARIKACE to treat NTM patients in the U.S. and Canada and look forward to having top-line data by the end of this year."