BioTime, Inc. (NYSE Amex:BTIM), Cell Cure Neurosciences Ltd., and Hadasit Bio-Holdings Ltd. (Tel Aviv Stock Exchange:HDST) jointly announced today that Cell Cure and Teva Pharmaceutical Industries Ltd. have entered into an exclusive license option agreement to develop and commercialize Cell Cure's OpRegenTM product for the treatment of age-related macular degeneration (AMD). OpRegenTM is a proprietary formulation of embryonic stem cell-derived retinal pigment epithelial cells designed by Cell Cure to help save the sight of the baby boomer generation.
“We are happy and proud to see the company, which was established on the basis of technology developed at Hadassah Medical Organization, develop and grow to the point where it can aggressively advance its lead product into the clinic, with the support of the ultimate partners in the field.”
AMD is the leading cause of blindness in the aging population. The US Centers for Disease Control and Prevention estimate that about 1.8 million people in the United States have advanced stage AMD and another 7.3 million have an earlier stage and are at risk of vision impairment from the disease. Most people are afflicted with the dry form of the disease, for which there is currently no effective treatment.
"In evaluating potential partners for the development of our products, we concluded that Teva represents the ideal partner for this program," said Dr. Charles Irving, Chief Executive Officer at Cell Cure. "Their longstanding global leadership in development and commercialization of important new classes of medicines provides a great foundation for working together."
The ongoing development of OpRegenTM by Cell Cure is funded through equity investments by BioTime, Teva, and Hadasit Bio Holdings, made simultaneously with this agreement. Additional non-dilutive funding for the development of OpRegenTM has been provided by the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel.
Subject to the terms of the agreement, if Teva exercises its option to obtain an exclusive license to OpRegenTM, Teva will have responsibility for funding clinical trials from that point on, obtaining regulatory approvals, and marketing the product.
Cell Cure will be entitled to receive milestone payments and royalties if certain development, regulatory, and commercial milestones are achieved. A portion of the milestone payments and royalties received by Cell Cure would be shared with BioTime's subsidiary ES Cell International Pte Ltd. and with HBL's affiliate Hadasit Medical Research Services and Development Ltd., the technology transfer arm of the Hadassah Medical Organization ("HMO"), which have licensed to Cell Cure certain patents and technology used in the development of OpRegenTM invented by Prof. Benjamin Reubinoff and Prof. Eyal Banin.
"Cell Cure will be collaborating with one of the 15 largest pharmaceutical companies in the world, and with affiliates of Hadassah Medical Organization, to develop new treatments for diseases that rob millions of people of their eye sight," said Dr. Michael D. West, Chief Executive Officer at BioTime. "This is consistent with our focus on making Cell Cure, our majority owned subsidiary, a center for developing cell based therapies for retinal and neural degenerative diseases."
Ophir Shahaf, CEO of HBL added: "We are happy and proud to see the company, which was established on the basis of technology developed at Hadassah Medical Organization, develop and grow to the point where it can aggressively advance its lead product into the clinic, with the support of the ultimate partners in the field."