MONMOUTH JUNCTION, N.J., Aug. 8, 2011 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today reported results for the second quarter and six-months ended June 30, 2011.
Key Recent Highlights:Announced positive results through six cycles of data from the open-label phase 2 study of Arikace™ (liposomal amikacin for inhalation) in the treatment of cystic fibrosis (CF) patients with Pseudomonas lung infections Added to Russell 3000, Russell 2000, Russell Global, and Russell Microcap Indexes Clinical hold placed on Arikace™ phase 3 program by FDA; Insmed to supply currently requested information and data to the Agency by end of August; FDA's response expected within 30 days of receipt of the Company's complete response to the Agency's requests
"We continue to believe Arikace™ has the potential to be an important treatment option for CF patients and those suffering from non-tuberculous mycobacterial (NTM) lung disease based on the efficacy and safety data generated from our phase 2 clinical trial program," said Timothy Whitten, Insmed's President and CEO. "We believe that we are taking the appropriate steps with FDA to address the findings from the interim results of our long-term rat inhalation carcinogenicity study that led to the clinical hold. Moreover, after reviewing the data, we believe we have a sound scientific rationale for those findings and look forward to working closely with our experts and with FDA to provide the Agency with all relevant information and data required to expedite their review and evaluation. Depending upon the timing and results of FDA's review, we are hopeful that we can resume our phase 3 clinical trial program for Arikace™ during the fourth quarter of 2011."
Financial Results:For the second quarter of 2011, Insmed posted a net loss attributable to common stockholders of $10.0 mi