New System Will Support Commercial-Scale Manufacturing of Cell Therapies and Other Patient-Specific Products
New York, NY and San Diego, CA Jan. 12, 2015 — NeoStem, Inc. (Nasdaq:NBS), a leader in the development and manufacturing of cell therapy products and regenerative medicine, and Invetech Pty Ltd (“Invetech”), a global leader in instrument development, custom automation and contract manufacturing, today announced an agreement for the development of a new closed processing system (the “System”) for cell therapy manufacturing. Under the agreement, Invetech will provide system design and engineering development and NeoStem will develop applications for performing closed cell processing manipulations such as separation. The agreement envisions NeoStem as the commercial supplier of the System which would constitute its first branded entry into the cell therapy tools market.
The System will be applicable to a range of cell therapy processes in development and commercialization stages, and will consist of an instrumentation platform, disposable flow path, and operating and application software for automated execution of user-selected protocols. The System will provide a flexible small scale process suitable for GMP manufacturing of autologous and other patient-specific products where small scale is full scale, while also supporting efficient development of processes at lower cost prior to transitioning to scaled volumes.
“We are pleased to be partnering with Invetech on the development of a new technology specifically designed to meet the needs of our clients as their cell therapy products progress through clinical trials on a path towards commercialization,” said Robert A. Preti, Ph.D., president of PCT, and chief scientific officer of NeoStem. PCT will carry out the work and is a wholly-owned subsidiary of NeoStem.. “By combining PCT’s more than 15 years of process development and manufacturing experience with Invetech’s industry leading automated processing device expertise, we hope to produce and potentially market a system that would deliver significant cost of goods, quality, and scaling benefits over existing manual, cleanroom-based processing strategies.”
“Working with NeoStem to create equipment that will deliver services to companies in the emerging cell therapy industry is exciting and satisfying,” said Richard Grant, global vice president, cell therapy division of Invetech. “Our team shares a common passion with NeoStem to grow the cell therapy industry by developing new technology to support successful product development and commercialization.”
“NeoStem’s Engineering and Innovation Center (EIC) is one of the first dedicated centers responding directly to the major challenges that are facing the manufacturers of cell based therapeutics,” said Brian Hampson, vice president, manufacturing development and engineering. “If ultimately commercialized, the sale of disposables associated with the System, especially for patient-specific therapies where one disposable set is used per patient, could potentially become a meaningful revenue area for NeoStem.”
NeoStem is a biopharmaceutical company pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The combination of a rich therapeutics pipeline and externally recognized in-house manufacturing expertise has created an organization with unique capabilities for cost effective and accelerated product development. www.neostem.com
Invetech has been creating breakthrough products and custom automation systems for more than 30 years. With experience drawn from more than 5,000 projects globally, Invetech partners with global leaders in industry to deliver product design and development, contract manufacturing, and custom automation services. The company has experience in a broad range of market sectors including laboratory diagnostics, point of care diagnostics, life sciences, cell therapy, industrial and consumer products. With active projects in North America, Europe, and Asia Pacific, Invetech is well positioned to service clients ranging from startups to established multinationals. www.invetech.us
Forward-Looking Statements for NeoStem, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy, the Company’s ability to develop and grow its business, the successful development of cellular therapies with respect to the Company’s research and development and clinical evaluation efforts in connection with the Company’s Targeted Immunotherapy Program, Ischemic Repair Program , Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company’s contract development and manufacturing business as well as its efforts to expand its capabilities into the cell therapy tools market. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 13, 2014, the Company’s Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.