The case for Insmed's CF drug candidate Arikace; analysts' views
The 16% decline in US biotech firm Insmed’s (Nasdaq CM: INSM) stock is an overreaction to results from a pivotal Phase III study of Arikace (inhaled amikacin) in treating Pseudomonas aeruginosa in cystic fibrosis (CF) patients (The Pharma Letter July 1), say analysts at Edison Equity Research.
The CLEAR-108 study in 302 CF patients showed non-inferiority in lung function for once-daily Arikace compared to twice-daily TOBI (tobramycin), the standard of care with fiscal year 2012 global sales of $317 million. The headline efficacy and safety data suggest Arikace is an approvable drug, with filings in Europe and Canada planned for the first half of 2014, although the US situation needs to be resolved, the analysts note.
Focus on end-of-treatment cycle effect
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