Novartis has secured a worldwide license for the cell therapy of remestemcel-L mesoblasts in the treatment of COVID-19. The deal earns Mesoblast $ 50 million up front and support from a partner who could help address critical quality attribute issues raised by the FDA.
Last month, the FDA rejected an application for approval of cell therapy in children with steroid-resistant graft-versus-host disease (GvHD). By that time, Mesoblast had already started testing allogeneic cell therapy in COVID-19 patients with acute respiratory distress syndrome (ARDS). Phase 3, which began in May, aims to validate the signs of efficacy observed in a compassionate use program involving 12 patients.
Novartis stepped in to help Mesoblast advance remestemcel-L in ARDS. In exchange for an upfront payment of $ 25 million and an investment of $ 25 million, plus milestones and royalties, Mesoblast has given Novartis a worldwide license to develop and market remestemcel-L in ARDS.
Evidence of the prospects for remestemcel-L, a mesenchymal stem cell therapy, in ARDS linked to COVID-19 is expected to arrive when the 300-patient Phase 3 trial ends early next year. If the trial is successful, Novartis plans to work with Mesoblast to develop appropriate critical quality attributes that [FDA] requirements for remestemcel-L.
The focus on critical quality attributes reflects the problems Mesoblast faced when it tried to gain FDA approval for remestemcel-L in GvHD earlier this year. In its backgrounder, the FDA said the attributes have no demonstrated relationship to the clinical performance of certain [drug product] many. The advisory committee backed the drug, but the FDA issued a full response letter.
Novartis, which has approved cell therapy, may have the expertise to ensure that remestemcel-L performs best when reviewed by the FDA as a treatment for ARDS in COVID-19 patients. Novartis will also provide support to enable the scale-up of commercial manufacturing. Mesoblast has previously said it needs to dramatically increase manufacturing to serve the COVID-19 market.
The relationship between the companies goes beyond COVID-19. Novartis plans to conduct a Phase 3 trial in patients with non-COVID-19 ARDS, setting it up to address the broader unmet medical need. ARDS causes 40% mortality in the approximately 200,000 patients who develop the disease in the United States each year.
Novartis also has the possibility of distributing remestemcel-L outside of Japan in GvHD and of co-financing its development and commercialization in other non-respiratory indications. Shares of Mesoblast rose 18% in response to the news. Even after the bump, the action remains down on the highs it hit before the full response letter.
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