Mesoblast in deal with Novartis to develop COVID-19/ARDS stem cell therapy

 

• Mesoblast (NASDAQ:MESO) surges 17% after entering into an exclusive worldwide license and collaboration agreement with Novartis (NYSE:NVS) for the development, manufacture and commercialization of Mesoblast’s remestemcel-L, with an initial focus to develop treatment for acute respiratory distress syndrome (ARDS), associated with COVID-19.
• Novartis will make a $50M upfront payment including $25M in equity.
• From the initiation of a Phase 3 trial in all-cause ARDS, Novartis will fully fund global clinical development for ARDS and other respiratory indications.
• Mesoblast may receive pre-commercialization milestone payments of $505M for ARDS indications, up to $750M in post-commercialization milestones and tiered double-digit royalties on product sales.
• Mesoblast will retain full rights and economics for remestemcel-L for graft versus host disease, and Novartis has an option to become the commercial distributor outside of Japan.
• For most non-respiratory indications, the parties may co-fund development and commercialization on a 50:50 profit-share basis.
• Mesoblast will be responsible for manufacturing and Novartis will purchase commercial product under agreed pricing terms.
• NVS will reimburse Mesoblast up to $50M on the achievement of certain milestones.
• Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after closing of the license agreement and successful completion of the study.
• On Nov. 11, Mesoblast gets recommendation to continue Covid-19 ARDS trial without any modifications.
• https://seekingalpha.com/news/3638221-mesoblast-inks-deal-novartis-to-develop-covidminus-19-ards-stem-cell-therapy-sharesplus-17