New York, July 16, 2013 — NeoStem, Inc. (NYSE MKT:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy market, today announced the geographic expansion of intellectual property protection around its lead product candidate, AMR-001, with the notice of the issuance of patent number 2011127184 in Russia. This patent is in the family titled “Compositions and Methods of Vascular Injury Repair” and protects a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction (“AMI”).
“This incremental patent brings AMR-001’s total worldwide patent coverage to eleven patents, and offers AMR-001 product protection in this important geography,” said Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem. According to reports, cardiovascular disease accounts for 57% of all deaths in Russia, or approximately 1 million deaths per year, with a total economic cost corresponding to 3 percent of the country’s GDP for the period of 2006-2009. Psychosocial factors, high alcohol intake, tobacco smoking, eating habits, hypertension, physical inactivity, and obesity are all significant contributing risk factors in Russia, a country with a population of roughly 143 million.
“We look forward to further expansion of our intellectual property in the coming years, both in the United States and abroad,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem. “The Company is on track to complete enrollment this year in the Phase 2 PreSERVE AMR-001 clinical trial and expects to have the first data readout available six to eight months after the last patient is enrolled..”
NeoStem’s AMR-001 is a cell therapy in development for the treatment of cardiovascular disease. NeoStem If approved by the U.S. Food and Drug Administration and/or other worldwide regulatory agencies, AMR-001 would address a significant unmet medical need in the treatment of AMI and position the Company to capture a meaningful share of the worldwide AMI market.
About NeoStem, Inc.
NeoStem, Inc. (“NeoStem” or the “Company”) is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation.
For more information, please visit: www.neostem.com.
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 research and development and clinical evaluation efforts for cellular therapies, including with respect to AMR-001, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the Company’s ability to successfully grow its contract development and manufacturing business. 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 11, 2013 and in the Company’s 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 its control.