Alnylam retools Sanofi deal to take full control of patisiran

Sanofi will take home royalties of up to 25% on sales of patisiran in the markets it used to own. (Sanofi)

Alnylam has stepped up its commitment to pioneering RNAi drug patisiran by retooling its agreement with Sanofi. The revised deal returns full global control of the ATTR amyloidosis drug to Alnylam and sees Sanofi obtain worldwide rights to hemophilia candidate fitusiran.

That means the partnership is now mostly divided up by asset, not geography. Alnylam, having previously ceded control to patisiran outside of North America and Western Europe, is now in charge of bringing the drug to market around the world. In return, Alnylam is giving Sanofi full control of fitusiran, the hemophilia drug that was briefly held up by a FDA clinical hold last year.

Alnylam and Sanofi have replaced the split and codevelopment rights with royalties. Sanofi will take home royalties of up to 25% on sales of patisiran in the markets it used to own. And Alnylam will get tiered royalties of up to 30% on global sales of fitusiran.

Sanofi’s willingness to give responsibility for patisiran—and Alnylam’s interest in taking it—suggests the RNAi pioneer’s confidence in the drug will translate into a major, worldwide commercialization drive. 

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If Alnylam builds an effective, global commercialization operation, it will have a platform from which to introduce drugs including ALN-TTRsc02, givosiran and cemdisiran, provided they impress in the clinic. 

The revised agreement, like the 2014 pact it amends, coincides with the J.P. Morgan healthcare event. In 2014, the deal, notably Sanofi’s $700 million equity investment, represented a vote of confidence in Alnylam’s ability to guide a promising but unproven therapeutic approach to market. With that task nearly done, the revised deal sketches a new future for Alnylam, in which it builds on its R&D success to create the first commercial-stage RNAi biotech.