GE Healthcare and Geron Partner to Commercialize Stem Cell Drug

Giles, UK), a unit of General Electric Co., and Geron Corp. (Menlo Park, CA, USA) have entered into a global alliance and exclusive license agreement to 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 U.S. National Institutes of Health (NIH; Bethesda, MD, USA) Human Pluripotent Stem Cell Registry. Financial terms were not disclosed.

"This agreement 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,” said Konstantin Fiedler, general manager, Cell Technologies, GE Healthcare. "Combining GE Healthcare's reach into the drug discovery and research markets, as well our expertise in cell manufacturing, with Geron's expertise and IP [intellectual property] in hESCs, means that together, we will be able to accelerate the development of hESC-derived products for drug discovery and development.”

"Geron is intensely focused on developing hESC-based cell therapies, and 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,” said David J. Earp, J.D., Ph.D. Geron's senior vice president of business development and chief patent counsel. "In GE Healthcare we have found the ideal partner with whom to develop this near-term commercial opportunity. There is much anticipation of the availability of hESC-derived cells for drug discovery applications within the pharmaceutical industry and we look forward to working closely with GE Healthcare to deliver these promising products.”

Under the terms of the agreement, GE Healthcare has been granted an exclusive license under Geron's extensive intellectual property product range 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. 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. 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 considerably 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. The GE Healthcare-Geron alliance aims to develop cellular assay products derived from hESCs that could be used in early in vitro screening of drug candidates.

Cells derived from hESCs have similar attributes to their counterparts in the body, and can therefore be used to predict many pharmacological characteristics of a drug candidate. Cardiotoxicity and hepatotoxicity are the most common causes of drug safety liabilities and withdrawal of drugs during development. Derivation of functional cell types from hESCs, in particular hepatocytes of the liver and cardiomyocytes of the heart could provide an effective supply of cells to perform metabolism, biodistribution , and toxicity testing of drug candidates.

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 that 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 terms of 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.

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