MSB 3.21% $1.13 mesoblast limited

TYPE A OUTCOME AND NOVARTIS PARTNERSHIP, page-7

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    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
    Last edited by Sam_123: 20/11/20
 
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