Mesoblast (ASX:MSB; Nasdaq:MESO) is developing and commercializing allogeneic cellular medicines to treat serious and life-threatening inflammatory diseases with significant, unmet medical needs.
The Company's Phase 3 off-the-shelf mesenchymal lineage cell product candidates are:
• RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD)
• Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection
• REVASCOR® for advanced chronic heart failure, and
• MPC-06-ID for chronic low back pain due to degenerative disc disease.
The US FDA has accepted for priority review Mesoblast's BLA to seek approval of RYONCIL to treat acute GVHD in children and set a PDUFA action date of September 30, 2020.
The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing reviewof independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians.
Mesoblast has an extensive patent portfolio comprising approximately 1,000 patents and patent applications with protection extending through 2040 in all major markets. This intellectual property portfolio covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells. The Company believes this patent estate provides strong global protection.
