Sanofi, Alnylam Restructure RNAi Therapeutics Pact for Rare Diseases
Sanofi and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based biopharmaceutical company focused on RNAi therapeutics, have announced a restructuring of their RNAi therapeutics alliance to streamline development and commercialization of certain products for treating rare genetic diseases.
Under the agreement, Sanofi will obtain global development and commercialization rights to fitusiran, an investigational RNAi therapeutic, currently in development for treating people with hemophilia A and B. Global commercialization of fitusiran, upon approval, will be done by Sanofi Genzyme, the specialty care global business unit of Sanofi. Alnylam will receive royalties based on net sales of fitusiran products. Alnylam intends to substantially complete the transition of fitusiran to Sanofi by mid-2018.
Alnylam will obtain global development and commercialization rights to its investigational RNAi therapeutics programs for treating ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will receive royalties based on net sales of these ATTR amyloidosis products. Sanofi intends to substantially complete the transition of its patisiran activities in regions outside the US, Canada, and Western Europe, consistent with the original scope of its license rights to patisiran, by mid-2018.
With respect to other products falling under the RNAi therapeutics alliance, the material terms of the 2014 Alnylam-Sanofi Genzyme alliance remain unchanged.
Sanofi Genzyme and Alnylam will be eligible to receive tiered royalties of 15% to 30% on global net sales of ALN-TTRsc02 and fitusiran, respectively, upon approval and commercialization. For patisiran, Sanofi Genzyme will be eligible to receive royalties, increasing over time to up to 25%, on sales in territories excluding the US, Canada, and Western Europe. Sanofi continues to have the right to opt into other Alnylam rare genetic disease programs for development and commercialization in territories outside of the US, Canada and Western Europe as well as one right to a global license.
The transaction is subject to customary closing conditions and clearances, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.