Basilea reports that isavuconazole receives orphan drug designations in Europe for the treatment of invasive mold infections

Basilea Pharmaceutica AG / Basilea reports that isavuconazole receives orphan drug designations in Europe for the treatment of invasive mold infections . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, July 14, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the European Commission granted isavuconazole orphan drug designations for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). Isavuconazole is an investigational intravenous and oral broad-spectrum antifungal.

An orphan drug designation provides several benefits to the sponsor including ten years of market exclusivity independent of any existing patent protection, should the product be approved in the European Union (EU). As a standard procedure, the maintenance of the European orphan drug status will require confirmation during the review of a future Marketing Authorization Application.

Ronald Scott, Basilea's Chief Executive Officer, commented: "Invasive aspergillosis and mucormycosis are life-threatening mold infections primarily affecting patients with an impaired or weakened immune system. Isavuconazole is the first antifungal to have EU orphan drug status both for the treatment of invasive aspergillosis and mucormycosis. The designation is an important regulatory milestone for Basilea and supports our development strategy for isavuconazole in Europe."

Basilea's co-development partner Astellas recently submitted a U.S. New Drug Application, seeking approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis. On this basis, Basilea is preparing a European Marketing Authorization Application (MAA). The MAA is planned to be filed, as scheduled, mid-2014.

About the isavuconazole phase 3 program

The phase 3 program with isavuconazole includes three studies, SECURE, VITAL and ACTIVE. The SECURE study was a global double-blind randomized study and evaluated the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole in the primary treatment of invasive fungal disease caused by Aspergillus species or other filamentous fungi. The VITAL study was an open-label study of isavuconazole in the treatment of aspergillosis patients with pre-existing renal impairment or patients with invasive fungal disease caused by emerging and often fatal molds, yeasts or dimorphic fungi. The ACTIVE study is currently enrolling patients and will evaluate the safety and efficacy of intravenously (i.v.) and orally administered isavuconazole versus i.v. caspofungin followed by oral voriconazole in the treatment of invasive Candida infections. The SECURE and VITAL studies are the basis of the regulatory filings in Europe and the U.S.