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Basilea Pharmaceutica AG: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
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Basilea Pharmaceutica AG And Astellas Pharma Inc Reports Positive Topline Phase 3 Results For Antifungal Isavuconazole
Basilea Pharmaceutica AG announced positive topline data from the isavuconazole phase 3 invasive aspergillosis study (SECURE). The antifungal agent isavuconazole is being co-developed with Astellas Pharma Inc. The randomized, double-blind isavuconazole study (SECURE) achieved its primary objective in demonstrating non-inferiority versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population (N=516). The all-cause-mortality was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole group. The 95% confidence interval of the treatment difference between isavuconazole and voriconazole was within the pre-specified non-inferiority margin of 10%.
Latest Developments for Basilea Pharmaceutica AG
- Basilea Pharmaceutica AG receives notification from U.S. FDA of acceptance of filing of isavuconazole NDA for the treatment of invasive aspergillosis and invasive mucormycosis
- Basilea Pharmaceutica AG confirms FY 2014 guidance
- Basilea Pharmaceutica AG submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections
- Basilea Pharmaceutica AG announces isavuconazole received QIDP designation from U.S. FDA
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