Novartis secures exclusive rights for potential acute respiratory distress syndrome cell therapy - Seite 2

The demonstrated ability of Novartis to rapidly move from clinical to commercial scale with cell-based therapies will play a role in the successful development and potential commercialization of remestemcel-L, as will the nearly two decades of experience Novartis has in delivering first-in-class products that address areas of unmet respiratory need.

In March, an open label compassionate use program was conducted, which included 12 patients with COVID-19-related ARDS, who were being supported with mechanical ventilation. Remestemcel-L treatment was associated with an 83% survival rate.⁴ Based on those results, remestemcel-L is being studied in this population in an ongoing 300-patient Phase III study, conducted in collaboration with the Cardiothoracic Surgical Network, which is anticipated to be completed in early 2021.³ After the anticipated closing of the license agreement and successful completion and outcome of this ongoing study, Novartis and Mesoblast will work together to develop appropriate critical quality attributes that meet U.S. Food and Drug Administration requirements for remestemcel-L in advance of initiation of the Phase III study in non-COVID-19-related ARDS.  

Under the license agreement, Novartis will acquire the exclusive worldwide rights to develop, commercialize and manufacture remestemcel-L for ARDS, and will obtain access to an innovative cell-therapy platform with a range of potential applications in severe respiratory conditions and beyond. Novartis will make a $25 million upfront payment and invest $25 million in Mesoblast equity with additional payments and royalties due on achievement of agreed development, regulatory and commercial milestones. In addition, Novartis will provide certain support to enable commercial manufacturing scale-up. Novartis has the option, if exercised, to distribute remestemcel-L for graft versus host disease (GVHD) (outside Japan). Both parties have rights to co-fund development and commercialization for other non-respiratory indications. The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.