Mesoblast accelerates Singapore manufacture plans
THE ROADHOUSE PHARMACY: Mesoblast Limited (ASX: MSB) is bringing forward plans for its commercial manufacturing operations in line with anticipated product launches in the United States and other major markets.
Mesoblast also announced that it will receive incentives from the Singapore Economic Development Board (EDB) for activities in Singapore related tomanufacturing operations, as well as product development and commercialisation.
“Bringing forward commercial manufacturing operations in Singapore is an important part of our overall global strategy as we prepare for product launches,” Mesoblast chief executive Silviu Itescu said in the company’s announcement to the Australian Securities Exchange.
“Singapore offers Mesoblast important benefits for our commercial, manufacturing and research operations. In particular, Singapore’s business friendly environment, focus on cellular therapies and strong scientific base, supported by the EDB and the Agency for Science, Technology and Research (A*STAR), are all assets to Mesoblast.”
Mesoblast’s existing operations in Singapore include clinical manufacturing supply of its proprietary mesenchymal lineage products under contract manufacturing agreements with Lonza, a leader in the pharmaceutical and biotechnology industries.
These agreements include exclusive access by Mesoblast to Lonza’s existing state of the art facilities in Singapore for allogeneic stem cell therapy, subject to certain exceptions.
In addition, under these agreements, Mesoblast can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for Mesoblast’s use.
Mesoblast said access to state of the art manufacturing facilities enables it to benefit from advanced bioprocessing technologies to ensure that it meets global market opportunities and capacity requirements for its proprietary mesenchymal lineage products.
Prochymal®, the world’s first approved allogeneic stem cell therapeutic and the only allogeneic stem cell therapeutic designated by the United States Food and Drug Administration as both an Orphan Drug and Fast Track product, is Mesoblast’s most advanced product and is being first developed for the treatment of steroid-refractory Graft Versus Host Disease.
Other major late-stage indications for Mesoblast’s mesenchymal lineage products include congestive heart failure, degenerative disc disease, and Crohn’s disease.
Website: www.mesoblast.com