ACT Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for hESC-Derived RPE Cells for Treatment of Stargardt’s Disease
MARLBOROUGH, Mass., March 10, 2011 /PRNewswire/ — Advanced Cell Technology, Inc. (“ACT”; OTC Bulletin Board: ACTC), a leader in the field of regenerative medicine, announced today that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has announced a positive opinion of ACT’s human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells for designation as an orphan medicinal product for the treatment of Stargardt’s disease. This opinion will now be forwarded by the EMA to the European Commission for their adoption, which should follow in coming weeks. This follows on the US Food & Drug Administration’s granting of Orphan Drug Designation for the same program from ACT, last year.
“We are very pleased to receive this positive opinion for Orphan Drug Designation from the EMA for our hESC-derived RPE cells for the treatment of Stargardt’s disease,” said Gary Rabin, ACT’s interim chairman and CEO. “There is currently no approved treatment for Stargardt’s disease, and we are working diligently to move this European trial forward as quickly as possible.”
Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU). In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides companies with scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, as well as reductions in certain fees associated with the application and approval process.
About Stargardt’s Disease
Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium (RPE).
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.
Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2009. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.
Contact: Investors: CEOcast, Inc., James Young, 212-732-4300 Press: ACT Corporate Communications, Bill Douglass, 646-450-3615 or: Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292
SOURCE Advanced Cell Technology, Inc.