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Insmed Incorporated Provides Regulatory Update on ARIKACE® in Non-Tuberculous Mycobacteria Indication
Date:10/14/2011

MONMOUTH JUNCTION, N.J., Oct. 14, 2011 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the Company has been notified by the U.S. Food and Drug Administration (FDA) that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trial for ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.  

As announced on August 1, 2011, the clinical holds placed on ARIKACE in NTM and Cystic Fibrosis (CF) patients with Pseudomonas lung infections 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.  

Insmed has been informed by FDA that, based on its review of the information provided to date, including the rat inhalation carcinogenicity study results, the Agency has insufficient information to assess the risks of ARIKACE in NTM patients in the planned phase 3 clinical trial.  FDA is requiring that Insmed conduct a phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for ARIKACE in NTM before the Company can proceed with a phase 3 clinical trial.  In addition, Insmed will also need to further revise the assessment of the rat carcinogenicity study findings in the investigator brochure.

"Now that we have responses from FDA with respect to both clinical holds, we are seeking further input from the Agency in order to gain a better understanding of their requests regarding CF and NTM," said Timothy Whitten, President and CEO of Insmed.  "Once we have received clarifications from FDA on their requests, and have sufficient opportunity to evaluate poten
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SOURCE Insmed Incorporated
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3. Insmed Announces Financial Results for Second Quarter and Six-Months Ended June 30, 2011
4. Insmeds ARIKACE® Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections
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