Sanofi Genzyme, the specialty care global business unit of Sanofi, has opted in with Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based biopharmaceutical company focused on RNAi therapeutics, to co-develop (through Sanofi research and development) and co-commercialize fitusiran, an investigational RNAi therapeutic for treating hemophilia and rare bleeding disorders, in the US, Canada, and Western Europe.

Based on an alliance formed by two companies in January 2014, 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 interim clinical results from a Phase I study of fitusiran. Alnylam said it is on track to initiate the fitusiran Phase III program in early 2017.

In January 2014, Alnylam and Sanofi Genzyme formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in the US, Canada, and Western Europe while Sanofi Genzyme obtained the right to access certain programs in Alnylam’s current and future genetic medicines pipeline in the rest of the world through the end of 2019, together with certain broader co-development/co-commercialization rights and global rights for certain products.

Alnylam and Sanofi Genzyme will now co-develop and co-commercialize fitusiran in the co-commercialization territory outlined in their agreement: the US, Canada, and Western Europe. Sanofi Genzyme will retain exclusive rights to develop and commercialize the product in the 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 initiation of the first global Phase III 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 20% 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. Based on this decision, Alnylam intends to develop and commercialize ALN-AS1 globally upon product approval.

Source: Alnylam Pharmaceuticals