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January 7, 2019

Sanofi revises immuno-oncology deal with Regeneron

Sanofi and Regeneron Pharmaceuticals have revised a global immuno-oncology discovery and development agreement to develop new treatments for cancer.

Sanofi and Regeneron Pharmaceuticals have revised a global immuno-oncology discovery and development agreement to develop new treatments for cancer.

Signed in 2015, the original agreement was set to end in the middle of next year. The restructured agreement will enable the partners to jointly develop two clinical-stage bispecific antibody programmes – BCMAxCD3 and MUC16xCD3.

In addition, Sanofi gains increased flexibility to advance of its early-stage immuno-oncology pipeline, while Regeneron retains all rights to its other immuno-oncology discovery and development programmes.

As part of the revised arrangement, Sanofi will pay $462m accounting to the balance of payments due under the original agreement.

Additionally, Regeneron will receive up to $120m in development costs for the two selected bispecific antibodies, along with the termination fee for the other programmes that were part of the original deal.

Under the terms of the restructured deal, Sanofi gets the right to opt-in to the bispecific programmes, which have achieved proof-of-concept or when the allocated funding has been expended.

Regeneron will provide up to $70m for the development of BCMAxCD3 to treat multiple myeloma and up to $50m to further develop MUC16xCD3 for mucin-16 expressing cancers.

“Sanofi gains increased flexibility to advance of its early-stage immuno-oncology pipeline, while Regeneron retains rights to other immuno-oncology discovery and development programmes.”

After opting-in for the programmes, Sanofi will be responsible for the development and commercialisation of the BCMAxCD3 bispecific, along with 100% funding of development costs.

Regeneron will reimburse up to 50% of its share of collaboration profits. The partners also agreed to share global profits equally.

Post opt-in, MUC16xCD3 development and commercialisation in the US will be led by Regeneron, while Sanofi will take care of commercialisation in ex-US markets.

Development costs and global profits for this bispecific will be equally shared by the companies.

Under the immuno-oncology alliance, Sanofi and Regeneron developed and obtained US Food and Drug Administration (FDA) approval for Libtayo to treat advanced cutaneous squamous cell carcinoma (CSCC).

The partners also submitted regulatory application for the drug in the European Union (EU).

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