Astellas Pharma Europe, a European subsidiary of Astellas, has introduced Dificlir (generic name: fidaxomicin) tablets in the Europe.
Dificlir, indicated to treat Clostridium difficile infections (CDI), is an orally administered, macrocyclic antibiotic that was developed by Optimer Pharmaceuticals.
Astellas gained rights to develop and commercialize Dificlir in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (CIS) from Optimer in February 2011.
Astellas is yet to make €50m milestone payment, with €40m due six months after MAA approval and a separate €10m due on the first launch of a product in the Territory.
Dificlir met its primary endpoint of non-inferiority to vancomycin and also significantly reduced the recurrence of CDI in patients by 47%relative to vancomycin (planned secondary endpoint, 13.0% versus 24.6%, p=0.0001) in clinical trials.