Fulcrum Therapeutics enters into collaboration and license agreement with Sanofi for development and commercialization of losmapimod in facioscapulohumeral muscular dystrophy

Fulcrum Therapeutics, a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, has entered into a collaboration and license agreement with Sanofi for the development and commercialization of losmapimod, an oral small molecule being investigated for the treatment of facioscapulohumeral muscular dystrophy (FSHD).

Under the collaboration and license agreement, Sanofi obtains exclusive commercialization rights for losmapimod outside of the U.S.

The collaboration and license agreement combines Fulcrum’s expertise in FSHD with Sanofi’s global reach and commitment to treating patients with rare diseases. Losmapimod is currently being evaluated in a global Phase 3 clinical trial for the treatment of FSHD, a chronic and progressive genetic muscular disorder that is characterized by significant muscle cell death and fat infiltration into muscle tissue.

Results from ReDUX4, the Phase 2 clinical trial evaluating losmapimod for the treatment of FSHD, demonstrated a slowing of disease progression and improved muscle health. Fulcrum expects to report topline data from REACH, the global Phase 3 clinical trial, in the fourth quarter of 2024. 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.

“Sanofi is a proven leader in developing therapeutics for rare neuromuscular diseases and is the ideal partner to maximize the opportunity and reach of losmapimod outside the U.S.,” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “This deal aligns with our core strategy, allowing Fulcrum to remain focused on preparations for commercialization of losmapimod in the U.S., while leveraging Sanofi’s exceptional global commercial capabilities and established infrastructure in key markets around the world. We are excited about the potential to provide the first approved treatment for FSHD patients, and we look forward to working with Sanofi to bring losmapimod to patients globally.”

“This partnership provides an exciting opportunity to expand Sanofi’s rare disease franchise and deliver the first approved FSHD treatment to patients with the strength and reach of our commercial organization,” said Burcu Eryilmaz, Sanofi’s Global Head of Rare Diseases. “Losmapimod has shown meaningful clinical benefits that underscore the disease-modifying potential and opportunity to address the high unmet need for a safe and effective drug that slows disease progression. With a deep commitment to bringing hope and new treatment options to patients, we look forward to working closely with Fulcrum as losmapimod advances through late-stage development.”

Per the terms of the agreement, Fulcrum will receive an upfront payment of $80.0 million and is eligible to receive up to an additional $975.0 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.

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