Mesoblast and Lonza 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 U.S. market launch of remestemcel-L and commercial supply to meet Mesoblast’s long-term market projections.
 
Mesoblast expects to complete filing of the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (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.
 
“Mesoblast is a true trailblazer, leading the way in developing life-changing cell therapies and working hard to soon make them available to large numbers of patients,” said Alberto Santagostino, senior vice president, head of cell and gene technologies, 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 commercialization 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.”
 
Silviu Itescu, chief executive, Mesoblast, “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.”