Novartis Enters Global Licensing Agreement with Mesoblast for Remestemcel-L in Acute Respiratory Distress Syndrome (ARDS)

November 22, 2020 /Bio ValleyBIOON/ -- Novartis recently announced the signing of an exclusive global licensing and collaboration agreement with Mesoblast for the development and commercialization of allogeneic mesenchymalStem Cells(MSC) therapy Ryoncil (remestemcel-L), for the treatment of acute respiratory distress syndrome (ARDS), including ARDS associated with coronavirus disease 2019 (COVID-19). This agreement will expand the portfolio by adding a potential first-in-class ARDS therapy.NovartisRespiratory product portfolio.

ARDS represents an area with significant unmet medical needs, where the current standard of care involves prolonged ICU stays and mechanical ventilation. As a potential first-ever therapy for ARDS, remestemcel-L utilizes mesenchymal stem cell (MSC)-based platform technology to treat this life-threatening condition and improve clinical outcomes.

Currently, remestemcel-L is being evaluated in a Phase 3 study enrolling 300 patients.NovartisA Phase 3 study for the treatment of non-COVID-19-related ARDS is planned to be initiated following the closure of the licensing agreement and the successful completion and outcome of the current Phase 3 study.

MSCs—Mesenchymal Stem Cells (Image source: myheart.net)

Under the licensing agreement, Novartis will obtain global exclusive rights to develop, commercialize, and manufacture remestemcel-L for the treatment of ARDS, and will gain access to an innovative cell therapy platform with broad application potential in severe respiratory diseases and other conditions.NovartisAn upfront payment of USD 25 million will be made, along with a USD 25 million equity investment in Mesoblast, with additional payments and royalties payable upon the achievement of agreed-upon development, regulatory, and commercial milestones.

Furthermore, Novartis will provide certain support to expand commercial manufacturing scale. If the option is exercised,NovartisThe right to select and distribute remestemcel-L for the treatment of graft-versus-host disease (GVHD) in territories outside Japan. Both parties have the right to jointly fund the development and commercialization of other non-respiratory indications. Closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (Antitrust Act) and certain other conditions.

MSC-Immunomodulation

In March this year, remestemcel-L was used to treat ARDS in COVID-19 patients through an open-label compassionate use program. Among the 12 patients with moderate to severe COVID-19-related ARDS who received mechanical ventilation support and were treated with remestemcel-L, 10 survived post-treatment, resulting in a survival rate of 83% (10/12) for those treated with remestemcel-L.

Based on these data, remestemcel-L is currently undergoing a Phase 3 study involving 300 patients in this patient population, conducted in collaboration with the Cardiothoracic Surgical Network, and is expected to be completed in early March 2021. Following the closure of the licensing agreement and the successful completion and outcome of the current Phase 3 study,NovartisMesoblast Plans to Launch a Phase 3 Study for the Treatment of Non-COVID-19-Related ARDS. (Bioon.com)

Original Source: Novartis secures exclusive rights for potential acute respiratory distress syndrome cell therapy