Overview of Collaboration with Novartis for Remestemcel-L
Worldwide license and collaboration agreement with Novartis for the development, manufacture and
commercialization of remestemcel-L
Initial focus is on the treatment of ARDS, including that associated with COVID-19, and other
respiratory conditions
ARDS is an area of significant unmet need, with a high mortality rate despite current standard of care,
which includes prolonged ICU treatment and mechanical ventilation.
Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after the anticipated
closing of the license agreement and successful completion and outcome of the current COVID-19
ARDS study
Mesoblast will retain full rights and economics for remestemcel-L for graft versus host disease
(GVHD), and Novartis has an option to, if exercised, become the commercial distributor outside of
Japan
For most non-respiratory indications, the parties may co-fund development and commercialization on a
50:50 profit-share basis
Novartis will make a US$50 million upfront payment including US$25 million in equity*
Mesoblast may receive a total of US$505 million pending achievement of pre-commercialization
milestones for ARDS indications
Mesoblast may receive additional payments post-commercialization of up to US$750 million based on
achieving certain sales milestones and tiered double-digit royalties on product sales
From the initiation of a Phase 3 trial in all-cause ARDS, Novartis will fully fund global clinical development
for all-cause ARDS and potentially other respiratory indications
Mesoblast will be responsible for clinical and commercial manufacturing and Novartis will purchase
commercial product under agreed pricing terms
Novartis will reimburse Mesoblast up to US$50 million on the achievement of certain milestones related to
the successful implementation of its next-generation manufacturing processes using its proprietary media
and three-dimensional bioreactors aimed at delivering substantial manufacturing efficiencies
Novartis will be responsible for any capital expenditure required to meet increased capacity requirements
for manufacture of remestemcel-L
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