Astellas and Optimer's C. difficile drug cleared in Europe

Following an earlier positive recommendation from a European Medicines Agency advisory panel (The Pharma Letter September 26), the European Commission has granted Marketing Authorization for Dificlir I (fidaxomicin; also known as Dificid) tablets, the first in a new class of drugs for the treatment of adults with Clostridium difficile infections (CDI) also known as Clostridium difficile-associated diarrhea (CDAD), from Japanese drug major Astellas Pharma (TYO: 4503) and USA-based originator Optimer Pharmaceuticals (Nasdaq: OPTR).

Astellas Pharma Europe is Optimer's exclusive licensee to develop and commercialize Dificlir in Europe and additional countries in the Middle East, Africa and the Commonwealth of Independent States (CIS). The Japanese firm acquired these rights for 165 million euros ($220.5 million at current exchange rates) early this year (TPL February 8). Dificid gained US Food and Drug Administration approval in May this year.

CDI is a significant problem in hospitals and long-term care facilities all over the world. The EMA approval was based on two large, multinational, Phase III clinical trials that demonstrated that Dificlir was as effective as oral vancomycin in treating CDI. Dificlir had a significantly lower rate of recurrence (including relapses) compared to vancomycin in the 30 days following treatment. Dificlir is the only drug approved by the EMA proven to significantly lower the rate of recurrence of CDI compared to oral vancomycin. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections.