Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights
Read the full news release here
CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that it has entered into a collaboration and license agreement with Sanofi (Nasdaq: SNY) 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 unparalleled 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.
What does this mean for our community?
It’s certainly great news that the eighth largest pharmaceutical company in the world has grown its stake in FSHD therapies. Sanofi’s investment helps to ensure that Fulcrum has the resources it needs to complete its Phase 3 trial of losmapimod and bring it before the U.S. Food and Drug Administration and European Medicines Agency for regulatory approval. We can also expect that Sanofi’s global reach and resources will help with the enormous costs associated with launching new drugs, costs that include educating doctors and patients, improving diagnosis and standard of care, and expanding access to genetic testing. You may recall that these issues are exactly what Project Mercury, the global initiative to speed therapies in FSHD, is focused on. The Society leads biopharma relationships for Project Mercury and will be working with Fulcrum and Sanofi to enhance collaborative efforts in these areas.
Reading between the lines, we can imagine that Sanofi made its decision after closely scrutinizing the data from losmapimod clinical trials. Finally, when a major pharmaceutical company makes this type of a deal, others undoubtedly take notice. Could similar collaborations be in store for the pioneering biopharma’s that are working on FSHD therapies? All in all, this is highly encouraging news.
How can I get in touch with the right person’s to help me and my family affected with FSHD out? Thanks!
Hello! Our FSHD Navigator program would be a great place to start if you are looking for connections or to get pointed in the right direction. Our volunteer Navigators can be contacted via phone, email, or contact form. You can find this contact info and more information on the Navigator webpage: https://www.fshdsociety.org/for-patients-families/fshd-navigator/.
When might Losmapimod be available to the public ?
This is promising news for FSHD patients! Sanofi’s involvement brings greater resources and global reach to commercialize losmapimod, potentially leading to faster approval and wider availability. Fingers crossed for positive phase 3 trial results!