Sanofi and Alnylam have entered a strategic restructuring of their RNAi therapeutics collaboration to optimise the development and commercialisation of select rare genetic disease treatment products.

As part of the new structure, Sanofi will receive global development and commercialisation rights to an investigational RNAi therapeutic fitusiran currently being developed to treat haemophilia A and B.

When approved, fitusiran will be commercialised by the firm’s specialist care global business unit Sanofi Genzyme, and Alnylam is set to obtain royalties depending on net sales of fitusiran products.

The drug candidate is intended to complement Sanofi Genzyme’s rare haematology portfolio.

The restructuring will provide Alnylam with global development and commercialisation rights to investigational RNAi therapeutics programmes, including patisiran and ALN-TTRsc02, for ATTR amyloidosis treatment.

“This restructuring will enable both parties to maximise the value of each asset and allows us to maintain shared economics across the alliance programme.”

Sanofi would receive royalties depending on net sales of these ATTR amyloidosis products. The deal is, however, subject to customary closing conditions and clearances.

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Sanofi Genzyme executive-vice president and head Bill Sibold said: “The new structure simplifies operations, providing both parties the agility needed to make these medicines available to patients as quickly as possible once approved.

“This restructuring will enable both parties to maximise the value of each asset and allows us to maintain shared economics across the alliance programme.”

The material terms for other products covered under the RNAi therapeutics Alnylam-Sanofi Genzyme alliance are set to remain unchanged.

Sanofi will continue to exercise an option to develop and commercialise additional Alnylam rare genetic disease programmes in territories outside of the US, Canada and Western Europe, along with one right to a global licence.