Insmed (Nasdaq: INSM) announced that the FDA has lifted the clinical hold on Arikace

Palm Beach, FL 1/20/12 (StreetBeat) -- Insmed Incorporated (Nasdaq: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease. Insmed continues to engage in discussions with FDA regarding the clinical hold placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.

The clinical holds placed on the ARIKACE programs in NTM and CF were based on an initial review by FDA of the results reported by Insmed of a long-term rat inhalation carcinogenicity study of ARIKACE.

FDA previously requested that Insmed conduct a phase 2 clinical trial of ARIKACE in adult patients with NTM to provide proof-of-concept efficacy and safety data before proceeding with a phase 3 clinical trial. As part of its on-going assessment of the appropriate path forward for the ARIKACE program, including the phase 2 trial of ARIKACE in NTM patients, the Company is continuing communication with FDA regarding the CF clinical hold.

Insmed also announced that it will move ahead with the 9-month dog inhalation toxicity study of ARIKACE as previously requested by FDA to determine if the findings of the rat inhalation carcinogenicity study are observed in a non-rodent model.

"We are pleased that FDA has lifted the clinical hold on the ARIKACE development program in NTM," said Timothy Whitten, President and CEO of Insmed. "Insmed continues to work closely with regulatory authorities regarding the development program for ARIKACE. We are initiating the work required to begin the 9-month dog study during the second quarter and are continuing our dialogue with FDA regarding the CF clinical program."

Insmed also announced that IPLEX® inventory has now been fully depleted. At present, about 10 patients remain on drug. Regarding potential future IPLEX initiatives, the Company is currently evaluating possible out-licensing opportunities for the drug.

The stock is currently trading up 30%, or $1.20, at $5.00.

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