Tuesday, November 10, 2015
Stemedica Establishes Stem Cell Commercial Manufacturing Facility
Stemedica expands manufacturing capacity for Phase III and commercial stem cell products
San Diego, California and Epalinges, Switzerland – November 10, 2015 – Stemedica Cell Technologies, Inc., a leading manufacturer of adult, allogeneic stem cells and preserved stem cell proteins, has signed, through its subsidiary Stemedica International SA, an agreement with Smith & Nephew to take over its commercial grade cell manufacturing facility in Lausanne, Switzerland. The facility has been approved by the Swiss Agency for Therapeutic Products (“Swissmedic”), the Swiss equivalent to the U.S. FDA. Stemedica has fully executed the transfer of its proprietary BioSmart Technology Platform™ which allows the company to produce multiple stem cell products for use in the treatment of several medical conditions currently in clinical trials in the United States and internationally.
Through a prior collaboration, Stemedica had initiated a technology transfer to this facility and had completed several engineering runs. This complementary operation will serve to augment Stemedica’s San Diego-based manufacturing facility which is licensed for clinical grade stem cell production. Stemedica plans to begin staffing the Swiss facility immediately and anticipates being fully operational in 2016.
David Cheatham, Stemedica International’s Business Manager, remarked, “Recommissioning an existing, high-quality facility, is a cost-effective, time-efficient solution for Stemedica to support the ever-growing demand for the Company’s unique stem cell products. With plans to add Swiss, European and Asian clinical trial sites, availability of a Phase III and commercial facility to manufacture the Company’s proprietary allogeneic stem cell lines will enable these important trials to move forward quickly and efficiently.”
Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica, said, “The addition of the Swiss facility is a major step forward for Stemedica, establishing the Company as a Phase III and commercial manufacturer of multiple lines of stem cell products and preserved stem cell proteins. Stemedica continues to achieve significant milestones as a global leader in stem cell manufacturing.”
“The Swiss facility not only increases Stemedica’s manufacturing capacity for North America and Asia, but it will also allow for the production of European Union-compliant products. This facility enables Stemedica to provide its proprietary stem cell technology to meet the growing needs of its subsidiaries and geographic distribution partners,” added Alex Kharazi, MD, PhD, Chief Technology Officer at Stemedica.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures multiple lines of allogeneic adult stem cells and stem cell factors. The company is licensed by the State of California, Department of Public Health, Food and Drug Branch to manufacture cGMP, clinical-grade stem cells currently used in U.S.-based clinical trials for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online at www.stemedica.com.
About Stemedica International S.A.
Founded in Epalinges, Switzerland, in 2008, Stemedica International S.A. is a global biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has an exclusive license to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit www.stemedica-intl.com.
Forward Looking Statements
This press release may contain forward-looking statements. Forward-looking statements in this release include statements regarding the manufacture of its Phase III and commercial stem cell products. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. Risks and uncertainties include, but are not limited to, Stemedica’s ability to staff its Swiss facility and become fully operational within the anticipated time period, or at all; the ability to comply with and meet applicable laws and regulations; and the continued demand for its products. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
Media and Business Contacts:
In the United States
Stemedica Cell Technologies, Inc.
Stemedica International S.A.
+41 (0)21 651 9050