MENLO PARK, Calif.—Geron Corp. has reached an agreement to provide stem cells to GE Healthcare for use in tools that will test for the toxic effects of drug treatments, a move that takes GE further into stem cell research.
GE Healthcare and Geron have established a multi-year alliance program under which scientists from the two companies will work closely together to develop hESC-based products for drug discovery. Under terms of the agreement, the partners will develop and commercialize cellular assay products derived from human embryonic stem cells (hESCs) for use in drug discovery, development and toxicity screening. The program will use stem cells derived from hESC lines listed on the National Institutes of Health's Human Pluripotent Stem Cell Registry.
According to Konstantin Fiedler, general manager of cell technologies and life sciences at GE Healthcare, the goals of the agreement are to develop and commercialize cellular assay products derived from human embryonic stem cells for use in drug discovery, development and toxicity screening. Working with Geron gives GE Healthcare "access to NIH-approved hESC lines, strong IP and wealth of expertise in hESC expansion and differentiation," he says.
Dr. David J. Earp, Geron's senior vice president of business development and chief patent counsel, points out that the company is focused on developing hESC-based cell therapies.
"The expertise that we have developed in scalable manufacturing and differentiation of hESCs to specific cell types is directly applicable to the production of these cells for drug discovery," Earp says. "In GE Healthcare, we have found the ideal partner with whom to develop this near-term commercial opportunity."
Earp says GE Healthcare and Geron would not disclose the financial terms of their alliance, which will involve some upfront payments by GE Healthcare, as well as milestones and royalties for successful development and sale of the products. According to Earp, GE Healthcare has been granted an exclusive license under Geron's extensive intellectual property portfolio covering the growth and differentiation of hESCs, as well as a sublicense under Geron's rights to the foundational hESC patents held by the Wisconsin Alumni Research Foundation.
The program will use stem cells derived from hESC lines listed on the NIH Human Pluripotent Stem Cell Registry. GE Healthcare will fund the R&D program and will be responsible for manufacturing, sales and distribution of products developed under the agreement.
Up to three quarters of toxicity problems are not detected until preclinical or later stages of drug development and this significantly increases the cost of developing new drugs. Earlier detection of toxicity problems could reduce both overall drug development costs and potentially harmful patient exposure in clinical trials, Earp says.
"This alliance aims to develop cellular assay products derived from hESCs that could be used in early in vitroscreening of drug candidates," Earp points out.
The combination of GE Healthcare's Cell Factory capability for cell reproduction and manufacturing with Geron's hESC technology will make it possible to generate a large scale supply of hESC-derived cells which retain normal cellular functions and could address bottlenecks in new drug research and accelerate the drug development process. The first products developed in the GE Healthcare and Geron alliance are expected to be available by early 2010, with a pipeline of products to follow.
Under the agreement, intellectual property rights arising from the alliance program research will be shared, with GE Healthcare receiving rights for the development of drug discovery technologies, and Geron receiving rights for cell therapy applications.
Fielder says the deal is designed to add another breakthrough technology to GE Healthcare's already strong portfolio of enabling technology in drug discovery and pharmaceutical development.
"Working closely with our customers we hope to further help them speed up and increase reliability of the drug discovery and development process," he says. "This marks a further step in GE Healthcare's cell technology strategy aimed at addressing the potential of stem cell applications in the drug discovery and therapy markets."
The initial tests of experimental drugs developed by the two companies for launch next year will help identify any effects on the heart, and a second test will look at effects on the liver—two vital organs studied closely by pharmaceutical companies and regulators.
According to Earp, the first products developed under this deal should be available by early 2010, with a pipeline of products to follow.
"If the science comes through, we believe this can be a reasonable goal," he says. "Success is going to be defined by launching the first products early next year."
For GE Healthcare, success will be measured by acceptance, Fiedler says.
"Through strong collaboration with our pharma customers, we hope to establish widespread acceptance and use of this technology in the drug discovery and development market," Fiedler says.
Selecting GE Healthcare was done through a process in which several companies were first considered. Earp said Geron had a short list of five companies and GE Healthcare rose to the head of the class.
Initially, Geron considered doing the work itself or spinning it off, but quickly dismissed those ideas.
"We were not going to do it in-house," he explains. "We did not want to divert our focus form therapeutics. We came to the conclusion that the best way was to find a partner. We looked at a number of potential companies as partners, and GE Healthcare was really the standout because it was clear they had made a strategic commitment to get into this area, they understood that a significant upfront investment would be required and they performed a lot of due diligence."
For Geron, the Obama administration's decision in March to lift certain restrictions on government funding of stem cell research has had minimal impact on its efforts. Earp points out that the company has never relied on federal funding. <!--[endif]-->
"The only impact it had on us was the ability to find academic collaborators," he says. "The policy of the Bush administration did suppress the ability for academic researchers to collaborate with companies on embryonic stem cells."
GE Healthcare says it will continue to abide by a statement it issued in 2005 saying it would follow National Institutes of Health policies and regulations on stem cell use.
"GE will not be associated with the primary harvest of human embryo-derived cells or tissues," the statement said. "We acknowledge the considerable debate and take very seriously the ethical and societal issues associated with research using stem cells derived from embryonic or fetal tissue. We conduct our research in an ethically and scientifically responsible manner."
Earp said the cells to be used under the pact with GE were derived from embryonic stem cells that were approved under policies established by the Bush administration in 2001.
