Slide 1: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements that are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Words, and variations of words, such as "intend," "expect," "will," "anticipate," "believe," "continue," "propose" and similar
Slide 2: ARIKACE Phase 3 Trial Primary Endpoint: Relative Change in FEV1
LS Mean Relative Change FEV1 (% ± SE) ARIKACE Phase 3 Trial Primary Endpoint: Relative Change in FEV1 ANCOVA Model Day 168: 95% CI for mean difference from ANCOVA ( -4.95, 2.34) Study Days Mean (SE) 128/135 128/134 127/134 127/135 125/135 127/132 127/135 126/132 TOBI® P-value 0.4809 Arikace
Slide 3: ARIKACE Phase 3 Trial Secondary Endpoint: Change in P. aeruginosa Sputum Density
LS Mean Change Sputum P. aeruginosa (log10 CFU ± SE) ANCOVA Model Day 168: 95% CI for mean difference from ANCOVA ( -0.878, 0.106) ARIKACE Phase 3 Trial Secondary Endpoint: Change in P. aeruginosa Sputum Density Study Days Mean (SE) 120/124 115/118 116/114 111/118 114/120 116/117 117/119 119/115 Ari
Slide 4: Overview of Adverse Events
Overview of Adverse Events Arikace® QD (N=148) TOBI® BID (N=146) Overall (N=294) Number (%) of subjects with treatment-emergent adverse events 125 ( 84.5) 115 ( 78.8) 240 ( 81.6) Number of treatment-emergent adverse events 614 435 1049 Number (%) of subjects with treatment-emergent adverse events by
Slide 5: Summary
Summary ARIKACE met the primary endpoint If approved, once a day ARIKACE comparable to twice a day TOBI® (current standard of care) A new antibiotic formulation with evidence of antimicrobial activity No unexpected adverse events and no difference in serious adverse events vs. TOBI* >75% of patients