Mesoblast Accelerates Plans For Commercialization Manufacturing Operations In Singapore


NEW YORK and MELBOURNE, Australia, May 27, 2014 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB; USOTC:MBLTY) today announced that it 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 to manufacturing operations, as well as product development and commercialization.

Mesoblast Chief Executive Silviu Itescu said: "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."

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.
 
Access to state of the art manufacturing facilities enables Mesoblast 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.
 
EDB Managing Director, Mr Yeoh Keat Chuan, said: "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."

Mesoblast Limited

Mesoblast Limited (ASX: MSB; USOTC: MBLTY) is a world leader in the development of biologic products for the broad field of regenerative medicine. The Company's proprietary technologies include its highly purified, immunoselected Stro-1/Stro-3 positive Mesenchymal Precursor Cells (MPCs), culture-expanded Mesenchymal Stem Cells (MSCs), Dental Pulp Stem Cells (DPSCs), and expanded Hematopoietic Stem Cells (HSCs). Mesoblast's protein technologies are based on factors derived from its proprietary cellular platforms, including Stromal Derived Factor-1 (SDF-1). Mesoblast's allogeneic or 'off-the-shelf' regenerative medicine products are being developed for the treatment of conditions with significant unmet medical needs. Product development focus is in four major and distinct areas - systemic diseases with an underlying inflammatory and immunologic etiology; cardiac and vascular diseases; orthopedic diseases of the spine; and improving outcomes of bone marrow transplantation associated with oncology or genetic conditions. www.mesoblast.com



            

Coordonnées