Sanofi Genzyme takes up option for experimental rare bleeding disorder drug, but says no to ALN-AS1

Sanofi Genzyme, a unit of French pharma major Sanofi (Euronext: SAN) has elected to opt in to co-develop and co-commercialize fitusiran, an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders (RBD), in the USA, Canada and Western Europe.

This expanded right is in addition to the previously exercised opt-in decision to develop and commercialize fitusiran in their rest of world territories under a January 2014 alliance with USA-based Alnylam Pharmaceutical (Nasdaq: ALNY). The opt in decision was based on recent promising interim clinical results from a Phase I study of fitusiran presented at the World Federation of Hemophilia (WFH) in late July and additional data that will be presented at the American Society of Hematology (ASH) meeting in December. Alnylam is on track to initiate the fitusiran Phase III program in early 2017.

Alnylam and Sanofi Genzyme will now co-develop and co-commercialize fitusiran in the co-commercialization territory (USA, Canada and Western Europe), while Sanofi Genzyme will retain exclusive rights to develop and commercialize the product in the Sanofi Genzyme Territory (rest of world).