By Colin Kellaher


Fulcrum Therapeutics has licensed the international rights to its proposed treatment for a rare, genetic muscular disorder to France's Sanofi in a deal potentially worth more than $1 billion to the clinical-stage biopharmaceutical company.

Fulcrum on Monday said it will work with Sanofi on the development and commercialization of losmapimod, which is currently in Phase 3 studies for the treatment of facioscapulohumeral muscular dystrophy, a chronic and progressive disorder characterized by significant muscle cell death and fat infiltration into muscle tissue.

Fulcrum said it will receive an up-front payment of $80 million from Sanofi and will be eligible to receive up to an additional $975 million in regulatory and sales-based milestones.

The agreement gives Sanofi exclusive commercialization rights for losmapimod outside the U.S., while Fulcrum, based in Cambridge, Mass., retains full U.S. commercialization rights.

Fulcrum said it will received tiered escalating royalties starting in the low teens on sales of losmapimod outside the U.S., adding that the two companies will equally share future global development costs of the drug.

Fulcrum said it expects to report top-line data from its Phase 3 study of losmapimod by the end of the year.

Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

05-13-24 0637ET