An MAA for fidaxomicin has been filed, and deal calls for $156 million in milestones.
Astellas Pharma is paying Optimer Pharmaceuticals $68 million up front for rights to fidaxomicin, an investigational antibiotic for Clostridium difficile infection (CDI). Optimer could earn another $156 million through regulatory and commercial milestone fees plus tiered double-digit royalties on net sales in Astellas’ territory. The deal covers Europe including countries in the Middle East and the Commonwealth of Independent States as well as Africa.
Astellas will take over all future costs associated with the development, manufacture, and commercialization of fidaxomicin in the licensed territory. Optimer filed an MAA, and Astellas will be responsible for it going forward. The FDA granted Optimer’s request for a six-month priority review of fidaxomicin and has assigned a PDUFA date of May 30, 2011.
“We believe the combined strengths of Astellas’ world-class anti-infective business capabilities including established relationships with payers and hospitals in Europe and certain other markets combined with Optimer’s novel therapeutic for CDI represents the most effective way to address a serious, unmet health need,” says Masao Yoshida, president and CEO of Astellas Pharma Europe.
Fidaxomicin is an orally administered macrocyclic antibiotic with a new mechanism and narrow spectrum of action. In two Phase III studies it was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI, according to Optimer. Fidaxomicin was statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47%, the firm adds.
