Fulcrum Therapeutics and Sanofi enter collaboration for facioscapulohumeral muscular dystrophy treatment
Betsy Goodfellow | May 14, 2024 | News story | Research and Development | Musculo-skeletal disorder, Sanofi, collaboration, fulcrum therapeutics, muscular dystrophy
Fulcrum Therapeutics has announced that it has entered into a collaboration and license agreement with Sanofi for the development and commercialisation of losmapimod, currently being assessed for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
The collaboration aims to combine Fulcrum’s experience in FSHD with Sanofi’s global reach and commitment to the treatment of rare diseases.
A global phase 3 trial is ongoing, assessing losmapimod for the treatment of FSHD, with results from the phase 2 trial demonstrating a slowing of disease progression and improved muscle health. Fulcrum intends to report topline data from the phase 3 trial during the fourth quarter of 2024.
Under the terms of this agreement, Sanofi will obtain exclusive commercialisation rights to the drug outside of the US, while Fulcrum will receive an upfront payment of $80m and up to $975m in specified regulatory and sales-based milestones, as well as tiered escalating royalties on annual net sales. The two companies will share future global development costs.
Alex C Sapir, Fulcrum’s president and chief executive officer, commented: “Sanofi is a proven leader in developing therapeutics for rare neuromuscular diseases and is the ideal partner to maximise the opportunity and reach of losmapimod outside the US. This deal aligns with our core strategy, allowing Fulcrum to remain focused on preparations for commercialisation of losmapimod in the US, 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.”
Betsy Goodfellow
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