Mesoblast enters into US$50m financing with NovaQuest Capital for commercial readiness of remestemcel-l in the treatment of acute Graft versus Host Disease
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced a US$50 million financing from NovaQuest Capital Management, L.L.C. (NovaQuest) for the continued development and commercialization of its allogeneic product candidate remestemcel-L (MSC-100-IV) for children with steroid refractory acute Graft versus Host Disease (aGVHD). NovaQuest was formed in 2000 as a strategic investment unit within Quintiles (now IQVIA), the world’s largest clinical research organization, and became an independent firm in 2010.
Mesoblast’s open-label Phase 3 trial enrolled 55 children with steroid-refractory aGVHD (aged between two months and 17 years) in 32 sites across the United States, with 89% of patients suffering from the most severe form, grade C/D aGVHD. The trial was performed under an United States Food and Drug Administration (FDA) Investigational New Drug Application (NCT#02336230). This trial previously met the primary endpoint of Day 28 overall response rate (69% versus 45% historical control rate, p=0.0003). Top line Day 100 results demonstrated 87% survival rate for Day 28 responders to remestemcel-L treatment (33/38), and an overall survival rate of 75% (41/55). The multi-infusion regimen of remestemcel-L was well tolerated.
Based on interactions with the FDA, Mesoblast believes that successful results from the completed Phase 3 trial, together with Day 180 safety, survival and quality of life parameters in these patients, may provide sufficient clinical evidence to file for accelerated approval of remestemcel-L in the United States, where there are currently no approved products for steroid-refractory aGVHD.
Mesoblast Chief Executive Dr Silviu Itescu stated: “We are pleased to have NovaQuest’s support for our plans to bring remestemcel-L to market. This transaction is underpinned by the strength of our GVHD Phase 3 clinical trial results. This trial is being managed in partnership with IQVIA, the clinical research organization that provides trial oversight and global development experience.”
NovaQuest partner Matthew Bullard said, “NovaQuest has been providing novel solutions to the biopharmaceutical industry to fund the development and commercialization of strategic assets for two decades that reduce the cost of care, meet unmet medical needs, improve efficacy and improve quality of life of patients.
Our extensive diligence leveraging our life science expertise and network of industry experts gives us confidence in the ability of Mesoblast to reach FDA approval and launch in the US for the treatment of aGVHD. We believe Mesoblast’s disruptive technology platform has the potential to be transformational in treatment of severe and life-threatening diseases such as aGVHD.”
NovaQuest will provide a non-dilutive US$40 million, eight-year term loan and purchase US$10 million of Mesoblast common shares. The per share equity purchase pr