Mesoblast and Lonza have announced that they have entered into an agreement for commercial manufacture of Mesoblast's lead allogeneic (off-the-shelf) cell therapy product candidate, remestemcel-L for pediatric steroid-refractory acute graft versus host disease (aGVHD). This agreement will facilitate inventory build ahead of the planned US market launch of remestemcel-L and commercial supply to meet Mesoblast's long-term market projections.
Dr Silviu Itescu, Chief Executive of Mesoblast, said: "This commercial manufacturing agreement with Lonza for our lead product candidate is designed to ensure that we are in a position to meet projected commercial demand as we plan to roll out the first of our allogeneic cell therapies to people around the world in need of life-saving and disease-modifying products."
Mesoblast expects to complete filing of the rolling Biologics License Application (BLA) submission to the US FDA by the end of this year. On acceptance of the filing, the product candidate is eligible for FDA priority review under its existing Fast Track designation, providing for an expedited review period. If approved, the US launch of remestemcel-L is expected to occur next year.
The agreement provides for Lonza to expand its Singapore cGMP facilities if required to meet long-term growth and capacity needs for the product. Additionally, it anticipates introduction of new technologies and process improvements which are expected to result in significant increases in yields and efficiencies.
Alberto Santagostino, SVP Head of Cell & Gene Technologies at Lonza: "This agreement builds on the successful partnership and alliance between our two companies over the years. As we also enter new partnerships with early-stage companies on one side, Mesoblast shows the path of success in reaching commercialisation on the other. We are committed for the long run with Mesoblast, to continue to grow and deliver cell therapies to all patients in need, together."
