Alnylam : Sanofi Genzyme Opt-in Decision For Co-Commercialization Of Fitusiran

(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY) said that, pursuant to the companies' global alliance signed in January 2014, Sanofi Genzyme elected to opt in to co-develop and co-commercialize fitusiran, an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders or RBD, in the United States, Canada and Western Europe.

The 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.

Alnylam and Sanofi Genzyme will now co-develop and co-commercialize fitusiran in the Co-Commercialization Territory (United States, 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). Certain development and sales and marketing costs for fitusiran will be shared 50/50 between Sanofi Genzyme and Alnylam.

In addition, Sanofi Genzyme will be required to make payments totaling up to $75 million upon the achievement of development and regulatory milestones for fitusiran. Upon the initiation of the first global Phase 3 clinical trial for fitusiran, Alnylam will earn a milestone payment of $25 million. Sanofi Genzyme also will be required to pay tiered double-digit royalties up to twenty percent on annual fitusiran net sales in the Sanofi Genzyme Territory. The companies will share profits equally in the Co-Commercialization Territory, where Alnylam expects to book product sales.

Sanofi Genzyme has elected not to opt in for ALN-AS1, an investigational RNAi therapeutic for acute hepatic porphyrias. Alnylam intends to develop and commercialize ALN-AS1 globally upon product approval. Alnylam will present initial results from Part C of the ongoing Phase 1 study at the ASH meeting in December.