Interstuming stem cell therapy! Novart signs license agreement with Mesoblast: Remestemcel-L to treat acute respiratory distress (ARDS)!

Nov 22, 2020 // -- Novartis recently announced that it has signed an exclusive global license and cooperation agreement with Mesoblast to develop and commercialize the isomer-filled stem cell (MSC) therapy Ryoncil(remestemcel-L) for the treatment of acute respiratory distress syndrome (ARDS), including ARDS associated with the new coronavirus pneumonia (COVID-19).
agreement will expand Novaral's respiratory portfolio by adding a potentially pioneering (first-in-class) ARDS therapy.
ARDS is an area where medical needs are significantly unfolevered, and current standard care includes extended ICU treatment time and mechanical aeration.
as the first potential ARDS therapy, remestemcel-L will use a cell-based platform technology, MSC, to treat this deadly disease and improve outcomes.
, remestemcel-L is currently being evaluated in a Phase 3 study of 300 patients in the group.
plans to launch a Phase 3 study on the treatment of non-COVID-19-related ARDS after the closure of the license agreement and the successful completion and results of the current Phase 3 study.
MSC-Intercharged Stem Cells (Photo: myheart.net) Under the license agreement, Novartis will have the exclusive global right to develop, commercialize and produce remestemcel-L for the treatment of ARDS, and will receive an innovative cell therapy platform with broad application potential for severe respiratory and other diseases.
will pay an advance of $25 million, a $25 million equity investment in Mesoblast, and additional payments and royalties after the agreed development, regulatory and commercial milestones are met.
addition, Novart will provide some support to expand commercial manufacturing.
, Novartic reserves the right to choose and distribute remestemcel-L to treat transplants against host disease (GVHD, outside Japan).
both parties have the right to co-finance the development and commercialization of other non-respiratory adaptations.
under the Hart-Scott Rodino Antitrust Improvement Act (Antitrust Act) and certain other conditions, the closure of a license agreement depends on the expiration or termination of the waiting period.
MSC-immunomodulation remestemcel-L is an allogeneic intersotopic charge stem cell (MSC) derived from msC isolated in the bone marrow of an unrelevant donor and prepared for culture amplification.
remestemcel-L is administered intravenously and has an immunomodulation effect, fighting inflammatory processes associated with a variety of diseases by reducing the production of inflammatory cytokines, increasing the production of anti-inflammatory cytokines, and recruiting naturally occurring anti-inflammatory cells into related tissues.
March this year, remestemcel-L treated ARDS in COVID-19 patients through an open-label compassion drug program, which included 12 cases of COVID-19-related patients supported by mechanical aeration Moderate/severe ARDS patients received remestemcel-L treatment, and 10 patients survived after treatment, i.e. 83% (10/12) of remestemcel-L.
based on this data, Remestemcel-L is currently conducting a Phase 3 study of 300 patients in this patient group, in collaboration with the Cardiothoracic Surgical Network, which is expected to be completed by early March 2021.
novart and Mesoblast plan to launch a Phase 3 study to treat non-COVID-19-related ARDS, following the closure of the license agreement and the successful completion and results of the current Phase 3 study.
() original source: Novartis secures exclusive rights for acute acute distress syndrome cell therapy