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Description of the Business
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9 Months Ended |
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Sep. 30, 2012
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| Description of the Business [Abstract] | |
| Description of the Business | 1. Description of the Business Insmed® is a biopharmaceutical company focused on developing and commercializing novel, targeted inhaled therapies for patients with high unmet need battling serious orphan lung diseases. Our lead product candidate, ARIKACE® (liposomal amikacin for inhalation), is a differentiated, inhaled antibiotic engineered to deliver a proven and potent anti-infective directly to the site of serious lung infections to improve the efficacy, safety and convenience of treatment for patients. Currently, we are continuing late-stage clinical trials for two initial primary target indications for this product: lung infections caused by Pseudomonas aeruginosa, which we refer to as Pseudomonas, in cystic fibrosis (CF) patients and lung infections caused by non-tuberculous mycobacteria (NTM). Our ongoing ARIKACE clinical development program includes a European and Canadian registration phase 3 clinical study of ARIKACE in CF patients with Pseudomonas lung infections (CLEAR-108) and an optional longer term open-label safety study (CLEAR 110), as well as a phase 2 clinical study of ARIKACE in patients with NTM lung disease (TARGET-NTM). We expect to report clinical results from both the CLEAR-108 and TARGET-NTM studies in 2013. Our sole development focus is to obtain regulatory approval for, and to prepare for commercialization of, ARIKACE in the U.S. and Europe. Corporate History We were incorporated in the Commonwealth of Virginia on November 29, 1999. We completed a business combination with Transave, Inc., or Transave, a privately held, New Jersey-based pharmaceutical company focused on the development of differentiated and innovative inhaled pharmaceuticals for the site-specific treatment of serious lung infections, on December 1, 2010. Our integration with Transave was completed in 2011. |