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20-F
MESOBLAST LTD filed this Form 20-F on 08/31/2018
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MPCs can be isolated using monoclonal antibodies and culture-expanded using methods that enable efficient expansion without differentiation. MSCs are defined biologically in culture following density gradient separation from other tissue cell types and following culture by plastic adherence. MSCs presumably represent culture-expanded in vitro progeny of the undifferentiated MPCs present in vivo. The functional characteristics of each cell type enable product development for specific indications.

Allogeneic, Off-the-Shelf, Commercially Scalable Products

Our proprietary mesenchymal lineage cell-based products have distinct biological characteristics enabling their use for allogeneic purposes.  

Immune Privilege:  Mesenchymal lineage cells are immune privileged, in that they do not express specific cell surface co-stimulatory molecules that initiate immune allogeneic responses.

Expansion: We have developed proprietary methods that enable the large scale expansion of our cells while maintaining their ability to produce the key biomolecules associated with tissue health and repair. This allows us to produce a cellular product intended to demonstrate consistent and well-defined characterization and activity.

In contrast, autologous stem cell products, which are produced from the patient’s own stem cells, require individual product regulatory testing and do not benefit from manufacturing economies of scale. Moreover, autologous therapies may be vulnerable to significant patient-to-patient variability.

Revenue Generating Products and Late-Stage Assets

Each of Mesoblast’s product candidates has distinct technical characteristics, target indications, individual reimbursement strategy, commercialization potential, and unique partnering opportunities.

Products Commercialized by Licensees

 

 

Mesoblast’s licensee in Japan, JCR Pharmaceuticals Co. Ltd., is marketing its mesenchymal stem cell-based product in Japan for the treatment of acute GVHD in children and adults. TEMCELL® HS. Inj., a registered product of JCR Pharmaceuticals Co Ltd., was the first allogeneic cellular medicine to receive full regulatory approval in Japan. Mesoblast receives royalty income on sales of TEMCELL® HS Inj in Japan.

 

In 2017, Mesoblast granted TiGenix NV, now a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”), exclusive access to certain of its patents to support global commercialization of Alofisel®, previously known as Cx601, the first allogeneic mesenchymal stem cell therapy to receive central marketing authorization (MA) approval from the European Commission. Mesoblast will receive royalty income on Takeda’s worldwide sales of Alofisel® in the local treatment of perianal fistulae.

Prioritized Portfolio of Advanced Product Candidates

We have prioritized our therapeutic programs into tiers based on stage of development, largest market opportunities and nearest term revenue potential. Tier 1 programs represent our lead programs where we focus the majority of our time and resources. These product candidates are discussed in detail below. Tier 2 programs are continually evaluated, and we may advance these programs into Tier 1 depending on merit of clinical data generated, market opportunity or collaboration opportunity. Additional product candidates may advance into Tier 1 and Tier 2 going forward.  

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