Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company today announced that, pursuant to the companies' global alliance signed in January 2014, Sanofi Genzyme elected to opt in to co-develop (through Sanofi R&D) and co-commercialize fitusiran, an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders (RBD), in the United States, Canada and Western Europe. This expanded right is in addition to their previously exercised opt-in decision to develop and commercialize fitusiran in their rest of world territories. The opt in decision was based on recent promising interim clinical results from a Phase 1 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 3 program in early 2017. "This marks another milestone for this landmark collaboration and an important step forward on the path to bringing RNAi therapeutics to patients. This decision allows us to broaden the global reach and accelerate the commercial development of fitusiran, a potentially transformative approach to the treatment of hemophilia and rare bleeding disorders, with a well-established partner in Sanofi Genzyme," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "We look forward to continued collaboration with Sanofi Genzyme to advance fitusiran as Alnylam transitions toward the commercial stage with our late-stage pipeline." "We are pleased to collaborate with Alnylam to develop this important and innovative potential new treatment option for people living with hemophilia across the world. We believe that significant unmet need still exists, particularly for patients with inhibitors, and we are excited by the promising early clinical data coming from the fitusiran program," said David Meeker, M.D., Executive Vice President and Head of Sanofi Genzyme. "This expanded collaboration with Alnylam supports our deep and lasting commitment to patients with rare diseases. We look forward to sharing our operational, regulatory and commercial experience with Alnylam as we advance this investigational product."