By Donald Zuhn --
On Tuesday, GTC Biotherapeutics, Inc. announced that it had been granted a non-exclusive worldwide license from stART Licensing, Inc. to use stART's nuclear transfer patents and patent applications to produce therapeutic proteins in the milk of transgenic animals.
GTC Biotherapeutics, Inc. commercializes therapeutic proteins through transgenic animal technology. GTC's ATryn®, a recombinant form of human antithrombin, was the first transgenically produced protein to be approved anywhere in the world (the European Commission has approved ATryn® for the treatment of deep vein thrombosis). ATryn® is produced in the milk of transgenic goats that have been developed by micro-injection.
stART Licensing, Inc. is a joint venture between Geron Corp. and Exeter Life Sciences, Inc. stART manages and licenses a portfolio of patent rights related to animal reproductive technologies, including the patents and patent applications involved in the licensing agreement. The licensed nuclear transfer technology was originally developed by the Roslin Institute for the cloning of Dolly the sheep.
Financial terms of the agreement include a $200,000 payment to stART and a split of 278,370 shares of GTC's common stock between stART and Exeter. In addition, GTC will pay royalties to stART on any products that GTC develops with the licensed technology. The agreement will remain in force through the expiration of the last of stART's nuclear transfer patents, which GTC expects to expire in 2016. While the patents and patent applications involved in the agreement have not yet been disclosed, the licensed technology may include U.S. Patent Nos. 6,525,243; 6,252,133; and 6,147,276; and a number of U.S. patent applications.
According to GTC's statement, the licensed technology will be utilized, as an alternative to micro-injection, to develop transgenic animals that incorporate a transgene into their genome for the expression of therapeutic proteins in the transgenic animal's milk. GTC also noted that by using nuclear transfer technology, it will be able to speed up the development of large-scale transgenic production capacity.
GTC Chairman and CEO Dr. Geoffrey Cox stated that GTC's "intellectual property portfolio provides patent protection for both the practice of our technology and the commercialization of our products," noting that GTC had received a U.S. patent in 2006 "for the production of therapeutic proteins in the milk of any transgenic mammal." According to Dr. Cox, the licensed stART technology would help "support[] our strategic focus on the development and commercialization of recombinant plasma proteins and monoclonal antibodies."
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