Fulcrum Therapeutics and Sanofi to Collaborate on Muscular Dystrophy Therapy

Ropes & Gray advised Fulcrum Therapeutics in a collaboration and license agreement with French pharmaceutical company Sanofi for the development and commercialization of losmapimod, an oral therapy being investigated for the treatment of the rare disease facioscapulohumeral muscular dystrophy (FSHD). Under the transaction announced on May 13, Sanofi obtains exclusive commercialization rights to losmapimod outside of the U.S and Fulcrum retains full U.S. commercialization rights.

Losmapimod is being evaluated in a global Phase 3 clinical trial for the treatment of FSHD, a chronic and progressive genetic muscular disorder characterized by significant muscle cell death and fat infiltration into muscle tissue. Following positive data from the Phase 3 trial, Fulcrum and Sanofi plan to submit marketing applications in the U.S. Europe, Japan and other geographies.

Under the agreement, Fulcrum will receive an upfront payment of $80 million and is eligible to receive up to an additional $975 million in specified regulatory and sales-based milestones, along with tiered escalating royalties starting in the low-teens on annual net sales of losmapimod outside the U.S. In addition, Fulcrum and Sanofi will equally share future global development costs.

The Ropes & Gray team was led by life sciences licensing partners Amanda Austin and Marc Rubenstein and life sciences licensing associate Ana Gomez-Palazzo.