Novartis has signed an exclusive US$50 million worldwide licence and collaboration agreement with Australian regenerative medicinecompany Mesoblast.
The agreement would allow Novartis to develop, manufacture and commercialise Mesoblast’smesenchymal stromal cell (MSC) product remestemcel-L, a cell-based platform technology.
The initial focus will be on developing a treatment for acute respiratory distress syndrome (ARDS), including that associated with COVID-19.
‘Novartis is committed to, and has demonstrated success with, cell-based therapies and transforming care for a spectrum of respiratory diseases,’ says John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer for Novartis.
‘This makes remestemcel-L an important addition to our pipeline. It has the potential to be the first treatment for the most critically ill ARDS patients, and it provides us with an opportunity to apply years of specialised experience directly to the work of saving lives.’
Remestemcel-L is being studied in COVID-19-related ARDS in an ongoing 300-patient Phase III study. Novartis intends to initiate a Phase III study in non-COVID-19-related ARDS after the closing of the licence agreement and successful completion and outcome of the current study.
‘Our collaboration with Novartis will help ensure that remestemcel-L could become available to the many patients suffering from ARDS, the principal cause of mortality in COVID-19 infection,’ says Mesoblast Chief Executive Dr SilviuItescu.
Novartis will make a US$50 million upfront payment including US$25 million in equity, with additional payments and royalties due when agreed development, regulatory and commercial milestones are achieved. Novartis will also provide support to enable commercial manufacturing scale-up. Both parties have rights to co-fund development and commercialisation for other non-respiratory indications.