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hESC Licensing Deal with WARF Spurs Product- Development Pact Between BD, StemCell Tech

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BD Biosciences and StemCell Technologies said last week that they have entered into a worldwide license agreement with the Wisconsin Alumni Research Foundation related to culture technology for human embryonic stem cells.
 
The licensing agreement also serves as a springboard for a product-development collaboration between BD and StemCell Technologies in which the companies will develop and commercialize hESC growth media and tissue culture surface products, the first of which will be launched this week, the companies said.
 
The IP at the core of the licensing deal is based on research conducted by stem cell pioneer James Thomson and Tenneille Ludwig at the University of Wisconsin-Madison and the WiCell Research Institute, a non-profit subsidiary of WARF. According to WARF, the relevant patents are still pending.
 
The USPTO has published two patent applications on which Thomson and Ludwig are listed as the primary inventors: US patent application no. 20060084168, entitled “Medium and culture of embryonic stem cells;” and US patent application no. 20040224401, entitled “Physiochemical culture conditions for embryonic stem cells.”
 
It is unclear whether the companies are licensing one or both patents, or any additional patent applications that may not have been published yet by USPTO. Financial or other additional terms of the agreement were not disclosed. However, Andy Cohn, government and public relations manager for WARF, said that the IP broadly relates to completely defined cell culture media and surfaces.
 
“This is a totally defined media, with no animal proteins whatsoever in it, which is a huge step forward,” Cohn said. Thomson, Ludwig, and colleagues first published their findings in the Feb. 2006 issue of Nature Biotechnology. Specifically, they reported feeder-independent hESC culture that includes protein components derived solely from recombinant sources or purified from human material.
 
According to Cohn, the researchers also demonstrated in the paper that the media possesses a “cleansing ability” that can eliminate any undesirable components that may have lingered even if the hESCs had originally been grown in undefined media.
 
Cohn said that WARF, StemCell Technologies, and BD began hammering out a licensing agreement last year, soon after the Nature Biotechnology paper was published and WARF had applied for patents on the technology. He said that searching for a suitor was a “unique” licensing exercise for WARF.
 
“We knew that we had great technology, and we were looking for the best partners,” Cohn said. “We did a request for proposals and got, I think, 12 proposals. We narrowed those down to four, and then we went and visited each of those companies, and brought our experts with us.
 
“We wanted to know who would be the best partner to develop this technology,” Cohn said. “It really came down to both BD and [StemCell Technologies], with [BD] having obvious expertise in production, marketing, and so on; and [StemCell] having great relationships with stem cell researchers.”
 
Cohn also termed the arrangement an “ongoing partnership.” As an example, he said that WiCell will be offering training seminars to teach prospective users about the media.
 
It appears that StemCell Technologies, based in Vancouver, BC, Canada, and BD Biosciences, based in Franklin Lakes, NJ, decided that they would be better served to co-develop products based on the technology rather than ink separate licensing deals with WARF because of their complementary strengths.
 
“StemCell Technologies has expertise in media, and BD has expertise in surfaces, so it was a natural fit for us to work together on this,” a BD spokesperson told BTW last week.
 

“StemCell Technologies has expertise in media, and BD has expertise in surfaces, so it was a natural fit for us to work together on this.”

Calls to StemCell Technologies were not returned in time for this publication. In a statement, president and CEO Allen Eaves said that his company “was very pleased to be working with both WiCell and BD to further expand the adoption and availability of complete cell environments pre-qualified for our customers’ critical research. Through the WARF license and our very productive, collaborative relationships with BD and WiCell, we are confident we have created a solid roadmap to innovation and standardization in the stem cell research field.”
 
Cohn said that he believes the companies began discussing a partnership during WARF’s request for proposal process. In the end, he said, “I think the three parties ended up deciding it was in everybody’s best interest to do this collaboratively.”
 
BD said that the first commercial products resulting from the licensing agreements and collaboration — a defined maintenance medium called mTeSR1 and compatible tissue culture surface called Matrigel hESC-qualified Matrix — are expected to be introduced this week at the International Society for Stem Cell Research annual meeting in Cairns, Australia.
 
Although the products are BD-branded, they will apparently be co-marketed by both companies, which this week put out a joint statement supporting the product launch.
 
Other major biotechnology companies are developing products for feeder-free hESC culture, most notably Invitrogen, which last June licensed intellectual property from Geron related to techniques for large-scale, feeder-free growth of hESCs.
 
But a major perceived disadvantage of feeder-independent growth of hESCs has been poorly defined serum and growth matrix components. It is unclear whether Invitrogen, Geron, or any other entity has developed defined media and growth surfaces for feeder-free hESC cultivation, but WARF’s Cohn said that his institution’s technology is first in class.
 
“My understanding is that this is the first totally defined media, and it’s been developed by the institution that has more experience with stem cells than any other place in the world,” he said.

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