NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement Jul 16 2012
SOTIO GMP Manufacturing Process to be Implemented at PCT
ALLENDALE, N.J. and WILMINGTON, Del., July 16, 2012 -- (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized Contract Development and Manufacturing Organization (CDMO), and SOTIO, LLC, a Delaware limited liability company that is responsible for organizing the U.S. part of a global pivotal Phase 3 clinical trial of SOTIO, LLC's affiliate, SOTIO a.s. ("SOTIO"), announced today that SOTIO, LLC has retained the services of PCT to manufacture clinical products for SOTIO's U.S. part of a global pivotal Phase 3 clinical trial. SOTIO, LLC is an affiliate of a Czech Republic-based biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. SOTIO, LLC will use the services of PCT to transfer and qualify at PCT's Allendale, New Jersey facility, SOTIO's GMP manufacturing process for the U.S. part of a global pivotal Phase 3 clinical trial for SOTIO's autologous dendritic cell vaccine expected to launch in early 2013, subject to FDA approval.
As part of this agreement, PCT will complete a technology transfer of SOTIO's current product manufacturing and analytical procedures into PCT's ongoing CDMO operations. PCT will then implement and perform process qualification at the Allendale facility, and manufacture, store, and release the product for SOTIO's U.S. part of its global pivotal Phase 3 trial. The U.S. part of this double-blinded, randomized trial will enroll up to 250 patients and will be SOTIO's first trial in the U.S.
"We are very excited to enter into this agreement to continue and to expand on our relationship with SOTIO, LLC, an innovator for cellular immunotherapies to treat prostate cancer," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. "Given our best in class capabilities in the manufacture and distribution of cell-based immunotherapies, we are pleased to work with SOTIO, LLC to assist with bringing this exciting therapy and its potential to the U.S. PCT will offer SOTIO, LLC the same expertise and dedicated service it has offered past clients like the Dendreon Corporation (Nasdaq:DNDN), for whom we were the primary manufacturer for PROVENGE® for more than seven years during its clinical trials."
"This agreement with PCT represents a major risk mitigation step in conducting the U.S. part of our global pivotal Phase 3 clinical trial," said Karel Nohejl, Chairman and CEO of SOTIO. "PCT has significant experience in manufacturing patient-specific products and capabilities to provide the scale-up needed for late-stage clinical trials. PCT's competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for SOTIO, LLC as we look forward to launching this trial in anticipation of entering the U.S. market."
"PCT offers cell therapy companies around the world a cost-effective method to transfer product candidate development to the U.S. and launch their products commercially," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "PCT's track record, experience with technology transfer, and U.S. footprint including its East and West Coast (Mountain View, California) facilities, make it an excellent partner for companies like SOTIO, LLC. Manufacturing contracts for cell therapy products can generate millions of dollars of revenue for the manufacturing partner over the span of a late stage clinical trial. We foresee meaningful client base growth as therapeutic development companies from Europe and Asia seek access to the American market and look for a U.S. contract development and manufacturing partner."
About SOTIO Group
SOTIO Group is a biotechnology group developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Its mission is to develop new medical therapies using SOTIO's proprietary cell-based technologies to treat highly unmet medical conditions using SOTIO's immunotherapy platform. World renowned scientists are working at SOTIO's research facilities in Prague using state-of-the art technologies to understand the role of dendritic cells in the therapeutic activation of the body's immune response. SOTIO plans to start a global pivotal Phase 3 clinical trial which will enroll U.S. as well as E.U. patients under the supervision of FDA and EMA. SOTIO, LLC is an affiliate of SOTIO and is responsible for organizing SOTIO Group's activities in the United States.
For more information on SOTIO, please visit www.sotio.com
About NeoStem, Inc.
NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.
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, including with respect to the Company's or its partners' successful development of cell therapeutics, as well as the future of the cell therapeutics industry and the rate at which such industry may grow. 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 on March 20, 2012 and in the Company's periodic filings with the Securities and Exchange Commission. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
For SOTIO press relations, please contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
1350 Avenue of the Americas, 28 Fl
New York, NY 10019
O: (646) 597-6987