We continue to build out our strategic alliances across commercial, clinical and manufacturing areas. These collaborations enhance the potential for the success of our product candidates, which mitigates our capital obligations and commercial risk.
Grünenthal GmBH, a global leader in pain management, and Mesoblast have entered into a strategic partnership to develop and commercialize Mesoblast’s product candidate MPC-06-ID for the treatment of chronic low back pain associated with degenerative disc disease in patients who have exhausted conservative treatment options in Europe and Latin America. The companies have agreed on an overall development plan for the product to meet European regulatory requirements. This plan includes collaborating on the study design for a confirmatory Phase 3 trial in Europe, with the results of the two Phase 3 trials expected to support both FDA and European Medicines Agency regulatory approvals for MPC-06-ID.
JCR Pharmaceuticals Co. Ltd has been granted an exclusive right in Japan to Mesoblast’s technology for use in conjunction with the treatment for hematologic malignancies using hematopoietic stem cell transplants derived from peripheral blood, cord blood or bone marrow. JCR has received Japanese Government regulatory approval for its mesenchymal stem cell-based product for children and adults with acute graft versus host disease. TEMCELL® HS Inj. is the first allogeneic cell-based product to receive full approval in Japan. In 2018, Mesoblast and JCR expanded their partnership in Japan to cover wound healing in patients with Epidermolysis Bullosa.
Tasly Pharmaceutical Group has been granted rights in China to develop, manufacture and commercialize Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product candidates Revascor for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or prevention of acute myocardial infarction. The parties plan to expedite development and commercialization of these cardiovascular product candidates by leveraging each other’s clinical trial results in China, and the United States and other major jurisdictions respectively to support their respective regulatory submissions for Revascor and MPC-25-IC.
In 2018, Mesoblast granted TiGenix NV (now fully owned by Takeda Pharmaceutical Co. Ltd) access to certain of its patents to support global commercialization of Alofisel® in the local treatment of fistulae. This product is the first allogeneic mesenchymal stem cell therapy to receive approval from the European Commission. As consideration, Mesoblast will receive up to €20 million in payments, as well as royalties on net sales.
Mesoblast has an alliance with the Lonza Group for long-term commercial manufacturing requirements of its product candidates. We believe this alliance provides Mesoblast with significant commercial advantages, including capacity to meet long-term global supply of its proprietary product candidates, access to Lonza’s cell therapy facilities in Singapore, and the potential for a purpose-built manufacturing facility to be built by Lonza to meet Mesoblast’s long-term commercial objectives.
Future collaborations
We will continue to evaluate and, where appropriate, enter into additional collaborations to further advance our product candidate portfolio and to gain access to scientific expertise or funding support.
For more information on business development or partnering opportunities, please email [email protected].
