Sanofi and Alynylam rejig sees global rights switch-up

The Sanofi-Alynylam alliance has been in place since 2014, with the latest development seeing the two companies each take their own commercialisation lead on patisiran and fitusiran, respectively.

The breakdown of the restructure sees Alynylam gain global development and commercialisation rights to its investigational RNAi therapeutics programs for the treatment of ATTR amyloidosis, which includes patisiran and ALN-TTRsc02.

While for Sanofi it means that the company will obtain global development and commercialisation rights to fitusiran, a candidate currently in development for the treatment of haemophilia A and B.

"This strategic restructuring enables streamlined development and an optimised approach to bringing innovative medicines to patients with ATTR amyloidosis and haemophilia around the world, maximizing the commercial opportunities for these programs," said John Maraganore, Chief Executive Officer of Alnylam. "For Alnylam, this provides strategic clarity and operational alignment with regard to the development and commercialization 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."

According to the press release, Alynylam will be eligible to receive tiered royalties of 15% to 30% on global sales of fitusiran, should Sanofi reach the market with the product.

The focus for Alynylam clearly now lies with patisiran, which is currently undergoing review by the FDA and the EMA, with conclusions expected to be reached mid-way through the year. Analysts expect, if the application process proceeds smoothly, that the drug could reach annual sales of $1 to $1.5 billion by 2023 for the biotech.

Alynylam’s main rival in the area is Ionis, with its candidate, inotersen, but analysts expect patisiran to take the lead in the area, with a likely 80%/20% split of the market in the former’s favour. Ionis was hit by GSK pulling out from its alliance on the drug in August of last year, a decision that panicked investors in the rival ATTR amyloidosis treatment.