Mesoblast and Lonza Enter into Agreement for Commercial Manufacture of Mesoblast’s Potential First United States Allogeneic Therapy

Mesoblast and Lonza 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 United States (US) 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 US 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.