Switzerland-based Basilea Pharmaceutica Ltd. (SIX: BSLN) provided an update today (July 17) on the Phase III program with the novel antifungal isavuconazole that is being developed in collaboration with Japanese drug major Astellas Pharma (TYO: 4503), under a 2010 deal that has the potential to earn $512 million for the Swiss firm (The Pharma Letter February 24, 2010).
Top-line data from the SECURE and VITAL Phase III studies are on track to be available in the second half of 2013. The SECURE registration study evaluates the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole for the primary treatment of life-threatening invasive fungal disease caused by Aspergillus species. The VITAL study is an open-label Phase III study in the treatment of aspergillosis patients with pre-existing renal impairment or with invasive fungal disease caused by emerging and often fatal fungi.
Initial regulatory filing likely in first part of 2014
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