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The FINANCIAL — Sanofi and its subsidiary Genzyme announced on October 1 that Genzyme has elected to opt into Alnylam’s investigational ALN-AT3 hemophilia program for development and potential future commercialization in territories outside of North America and Western Europe.

This marks the first product from Alnylam’s Genetic Medicines pipeline to which Genzyme has opted in since the formation of the companies’ global alliance in January 2014, and the third product opt-in overall. Genzyme’s opt-in decision was based on encouraging clinical data from the Phase 1 trial of ALN-AT3, including positive interim data that were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress in June 2015, according to Sanofi.

“Our collaboration with Genzyme is a key part of our strategy to advance RNAi therapeutics to global markets. Genzyme’s proven track record in developing and commercializing therapies for rare diseases makes them an ideal partner to advance an innovative medicine for the treatment of hemophilia. Accordingly, we are very pleased that they have elected to opt into the ALN-AT3 program, the first product opt-in since formation of our landmark alliance,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “We believe that ALN-AT3 holds tremendous promise as a new investigational medicine for the management of hemostasis in hemophilia and rare bleeding disorders. We look forward to working with Genzyme to advance ALN-AT3 as a potential new treatment option for people with hemophilia around the world.”

“ALN-AT3 represents a unique and promising new approach for the potential treatment of hemophilia,” said David P. Meeker, M.D., President and CEO of Genzyme, a Sanofi company. “We are excited to expand our clinical stage pipeline of treatments for patients with rare diseases, and to broaden our relationship with Alnylam.”

In January 2014, Alnylam and Genzyme formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases, i.e., programs in Alnylam’s Genetic Medicine Strategic Therapeutic Area.  Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam’s current and future Genetic Medicines pipeline in the rest of the world (ROW) through the end of 2019, together with certain broader co-development/co-commercialization rights and global rights for certain products. Alnylam maintains development and commercialization control for all programs in its territory.

ALN-AT3 is the third Alnylam product for which Genzyme has exercised its opt-in right, the first two occurring at the close of the deal in early 2014 for patisiran and revusiran, investigational RNAi therapeutics for the treatment of transthyretin-mediated amyloidosis. In the case of ALN-AT3, Genzyme has elected presently to opt into the program for its ROW rights. Genzyme retains its future opt-in right to co-develop and co-promote ALN-AT3 with Alnylam in North America and Western Europe. Specifically, Genzyme has the right to either co-develop and co-promote ALN-AT3 in Alnylam’s territory – with Alnylam maintaining development and commercialization control – or to maintain its ROW rights for ALN-AT3 and, if exercised by Genzyme, obtain a global license to ALN-AS1, Alnylam’s investigational RNAi therapeutic for the treatment of acute hepatic porphyrias.  Genzyme will exercise this selection right upon completion of human proof-of-concept for the ALN-AS1 program, which is expected to occur in 2016.

Per the 2014 agreement, Alnylam will receive R&D funding for programs where Genzyme has elected to opt in for development and commercialization. For “regional” programs where Genzyme will develop and commercialize in their ROW territory, such as patisiran and ALN-AT3 as currently structured, Genzyme pays 20% of global development costs. In the case of ALN-AT3, such cost sharing is expected to begin in January 2016. For “co-develop/co-promote” programs such as revusiran (and possibly ALN-AT3 in the future), Genzyme pays 50% of global development costs.  For “global” programs (e.g., possibly ALN-AS1 if selected), Genzyme will pay 100% of global development costs.  In addition, Alnylam is eligible to receive milestones totaling up to $75 million per product for regional and co-develop/co-promote programs.  In the case of global Genzyme programs, Alnylam is eligible to receive up to $200 million in milestones per product. Finally, Alnylam is also eligible to receive tiered double-digit royalties up to 20% on net sales on all products commercialized by Genzyme in its territories. In the case of Genzyme’s co-develop/co-promote products in the Alnylam territory, the parties will share profits equally and Alnylam will book net sales revenues.

 

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