Mesoblast, Lonza enter into manufacture agreement of remestemcel-L in U.S.
Mesoblast (MESO) and Lonza (LZAGY) announced that they have entered into an agreement for commercial manufacture of Mesoblast's lead allogeneic cell therapy product candidate, remestemcel-L for pediatric steroid-refractory acute graft versus host disease. This agreement will facilitate inventory build ahead of the planned United States 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 submission to the 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. MESO LZAGY