Insmed Incorporated Provides Regulatory Update

Insmed Incorporated

today announced that the Company has been notified by the U.S. Food and Drug Administration that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis patients with Pseudomonas lung infections. Insmed has not yet received a response from FDA regarding the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE in patients with non-tuberculous mycobacterial lung disease. As announced on August 1, 2011, the clinical holds placed on ARIKACE in CF and NTM were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the agency by Insmed with ARIKACE. At that time, FDA requested additional information on ARIKACE and data from the rat study. Insmed submitted its complete response to this request before the end of August.