Sanofi and Alnylam enter into RNAi therapeutics rare disease alliance

Sanofi and Alnylam Pharmaceuticals, announced a strategic restructuring of their RNAi therapeutics alliance to optimise development and commercialisation of certain products for the treatment of rare genetic diseases

Sanofi will obtain global development and commercialisation rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with hemophilia A and B.

Global commercialisation 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 will obtain global development and commercialisation rights to its investigational RNAi therapeutics programmes for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will receive royalties based on net sales of these ATTR amyloidosis products.

With respect to other products falling under the RNAi therapeutics alliance, the material terms of the 2014 Alnylam-Sanofi Genzyme alliance remain unchanged.

“The restructured alliance reflects Sanofi Genzyme's sustained interest in the strong potential of Alnylam's portfolio of genetic medicines. The new structure simplifies operations, providing both parties the agility needed to make these medicines available to patients as quickly as possible once approved,” said Bill Sibold, Executive VP and Head of Sanofi Genzyme.

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

Fitusiran complements Sanofi Genzyme's rare haematology portfolio and creates a focus on bringing an innovative product to market globally, upon approval, for people living with haemophilia, one of the most common rare diseases.

“This strategic restructuring enables streamlined development and an optimised approach to bringing innovative medicines to patients with ATTR amyloidosis and haemophilia around the world, maximising the commercial opportunities for these programmes,” said Dr John Maraganore, CEO of Alnylam.

“For Alnylam, this provides strategic clarity and operational alignment with regard to the development and commercialisation of patisiran and ALN-TTRsc02. This will allow us to develop both products in a comprehensive manner, potentially addressing the full spectrum of transthyretin mediated amyloidosis disease treatment and prevention. At the same time, we will continue to support and benefit — via royalties — from the fitusiran opportunity through Sanofi's significant development and commercial leadership.”

This restructuring provides Alnylam with the opportunity to consolidate its ATTR amyloidosis business to maximise its value, and the opportunity for near-term acceleration of product revenue growth based on newly obtained rights to commercialise patisiran around the world, once approved.

In addition, it enables Alnylam to build a global presence and commercial infrastructure that can be leveraged for ALN-TTRsc02 and additional programmes, including givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias and cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases — where Alnylam has retained global ownership.

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