Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous
fungi remain life threatening diseases. Early treatment with highly effective anti-fungals
reduces mortality. This study investigates the efficacy and safety of isavuconazole in the
treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Inclusion Criteria:

- Patients must have proven, probable or possible invasive fungal disease caused by
Aspergillus species or other filamentous fungi

- Female patients must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

- Patients with invasive fungal infections other than Aspergillus species or other
filamentous fungi

- Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction

- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary
aspergillosis

- Patients who have received more than 4 days of systemic antifungal therapy other than
fluconazole within the 7 days prior to the first administration of study medication

- Patients previously enrolled in a Phase III study with isavuconazole

- Patients with a body weight