USA – Fulcrum Therapeutics, a clinical-stage biopharmaceutical company, has inked a partnership and licensing agreement valued at up to US$1.05 billion with Sanofi to develop and commercialize losmapimod, an oral small molecule.
Losmapimod is currently undergoing evaluation as a potential treatment for facioscapulohumeral muscular dystrophy (FSHD), a rare and debilitating genetic disorder characterized by progressive muscle weakness.
Under the agreement, Fulcrum Therapeutics will receive an initial payment of US$80 million and the potential to earn an additional US$975 million through specified regulatory and sales-based milestones.
The collaboration also entails tiered escalating royalties, commencing in the low teens, on Losmapimod’s annual net sales outside the United States.
Additionally, Fulcrum Therapeutics and Sanofi will evenly split future global development expenses for the drug.
Alex Sapir, President, and CEO of Fulcrum Therapeutics, expressed confidence in the collaboration, stating, “Sanofi is a proven leader in developing therapeutics for rare neuromuscular diseases and is the ideal partner to maximize the opportunity and reach of losmapimod outside the US.”
Sapir emphasized the strategic alignment between the partnership and Fulcrum’s core objectives, allowing the company to focus on preparing for losmapimod’s commercialization in the US while leveraging Sanofi’s extensive global commercial infrastructure.
Losmapimod is being evaluated in a global Phase 3 clinical trial for treating FSHD. Topline data are anticipated in the fourth quarter of 2024.
Preliminary findings from the Phase 2 clinical trial, ReDUX4, demonstrated encouraging results, including a deceleration in disease progression and improvements in muscle health.
Fulcrum Therapeutics anticipates releasing topline data from the Phase 3 REACH clinical trial by the end of 2024.
In the event of positive outcomes, Fulcrum Therapeutics and Sanofi intend to pursue marketing applications in the US, Europe, Japan, and other global markets.
Burcu Eryilmaz, Global Head of Rare Diseases at Sanofi, emphasized the potential of losmapimod to address the pressing unmet needs of FSHD patients, emphasizing the drug’s clinical benefits and disease-modifying potential.
Eryilmaz reiterated Sanofi’s commitment to leveraging its robust commercial infrastructure to deliver losmapimod to patients worldwide.
Separately, Sanofi announced a significant investment exceeding €1 billion (US$ 1.26 billion ) to establish new bioproduction capacity at its facilities in France, stressing the company’s commitment to advancing biopharmaceutical manufacturing capabilities.
The publication of results from Fulcrum Therapeutics’ Phase 2b clinical trial of losmapimod in The Lancet Neurology provides crucial validation for the drug’s therapeutic potential.
While the trial’s primary endpoint did not demonstrate significant differences between treatment and placebo groups, losmapimod exhibited favorable outcomes in structural and functional measures and patient-reported assessments.
Furthermore, losmapimod demonstrated a favorable safety profile, with no treatment-related serious adverse events reported.
For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook
