Mesoblast Limited, a company developing biotherapeutics based on its proprietary cell-based and protein technologies, announced on Tuesday that it was moving forward with plans for its commercial manufacturing operations in accord with anticipated product launches in the United States and other markets.
In addition, Mesoblast revealed that it will receive incentives from the Singapore Economic Development Board (EDB) for activities in Singapore related to manufacturing 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. 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,” said Silviu Itesco, Mesoblast Chief Executive.
According to the news release on GlobeNewswire, Mesoblast’s operations in Singapore include clinical manufacturing supply of its proprietary mesenchyme lineage products under contract manufacturing agreements with Luna, a global leader in the pharmaceutical and biotechnology industries.
The company’s agreement with Luna provides Mesoblast with an access to Luna’s existing highly advanced facilities in Singapore for allogeneic stem cell therapy, subject to certain exceptions. It also allows Mesoblast to trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for Mesoblast’s use.
Access to Lonza’s state of the art manufacturing facilities means that Mesoblast can take full advantage of Lonza’s advanced bioprocessing technologies to ensure that it meets global market opportunities and capacity requirements for its proprietary mesenchyme 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.
“We are pleased that Mesoblast, the leading company in stem cell therapies and regenerative medicine, has chosen to establish a major presence spanning commercial manufacturing and R &D activities in Singapore. Stem cell therapy holds great potential for many unmet medical needs. Mesoblast’s decision is a strong endorsement of Singapore’s track record and ability to support new business opportunities in the biopharmaceutical industry,” said Mr Yeoh Keat Chuan, EDB Managing Director.