Basilea Pharmaceutica AG: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
Provider: Wright Reports
Basilea Pharmaceutica AG Announces Isavuconazole Orphan Drug Designation By U.S. FDA
Basilea Pharmaceutica AG announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis. An FDA orphan drug designation provides several benefits to the sponsor including a seven-year market exclusivity from product approval in the U.S. Isavuconazole was previously granted FDA fast track status that is designed to facilitate development and expedite the review of drugs to treat serious diseases and that fill an unmet medical need in order to get important new drugs to patients earlier. Topline data from two isavuconazole phase 3 studies are expected in the second half of 2013. These include the SECURE phase 3 registration study, evaluating safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species and from the open-label VITAL study investigating isavuconazole for the treatment of patients with invasive life-threatening fungal disease caused by emerging fungi and the treatment of aspergillosis patients with pre-existing renal impairment. The isavuconazole ACTIVE phase 3 study, evaluating the use of isavuconazole i.v. and oral versus caspofungin i.v. followed by oral voriconazole for the treatment of invasive Candida infections, will continue to recruit into 2014.
Latest Developments for Basilea Pharmaceutica AG
- Basilea Pharmaceutica AG Announces Isavuconazole Orphan Drug Designation For Treatment Of zygomycosis By U.S.
- Basilea Pharmaceutica AG And Astellas Pharma Inc Reports Positive Topline Phase 3 Results For Antifungal Isavuconazole
- Basilea Pharmaceutica AG's Board Proposes Martin Nicklasson To Succeed Chairman Werner Henrich
- Basilea Pharmaceutica AG Issues FY 2013 Operating Loss Guidance-Conference Call
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