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Pfizer Licensing Deal with WARF Allows Firm to Develop hESC-based Therapies, Discovery Tools

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This article was originally published on May 12.

Pfizer and the Wisconsin Alumni Research Foundation said last week that they have inked a licensing agreement that gives Pfizer the right to work with human embryonic stem cells for drug research and discovery.

With the deal, WARF has now inked 35 licensing deals with 27 corporate partners for its portfolio of patents related to isolating and differentiating hESCs in the late 1990s, Janet Kelly, WARF's director communications, wrote in an e-mail to BTW.

Pfizer is also the largest company and only pure-play pharmaceutical company that WARF has disclosed as a licensee of its hESC patent portfolio, Kelly said.

As such, the pharma giant's recent foray into regenerative medicine and subsequent need to license WARF's hESC patents for freedom to operate could symbolize a growing industry trend and additional pharma licenses for WARF's most lucrative IP asset.

WARF, the non-profit technology-licensing arm of the University of Wisconsin-Madison, "has licensed stem cell technologies to other pure-play pharma companies," Kelly said. However, those licensees have requested that their deals remain confidential.

Kelly said that other pharmaceutical companies have also expressed interest in licensing WARF's stem-cell patents, but their identities likewise could not be disclosed.

Other licensees of the patent that have been disclosed include Invitrogen, BioTime, Cellartis, CellCura, ES Cell International, Aruna Biomedical, Cellular Dynamics International, Becton Dickinson, ProteoSys, Geron, Stem Cell Technologies, Chemicon (a subsidiary of Millipore), Advanced Cell Technology, and Stemina Biomarker Discovery.

For Pfizer, the agreement gives the company's recently formed Pfizer Regenerative Medicine unit the freedom to pursue its goal of developing new stem cell-based therapies for a variety of diseases, as well as tools for drug-discovery research, the company said.

Under the terms of the agreement, the financial details of which have not been disclosed, WARF has granted Pfizer a license to "work with hES cells for drug research and discovery," the company said in a statement.

"Our license with WARF provides us with new information and materials that will allow us to use their cell lines to explore a whole new range of therapies," Ruth McKernan, chief scientific officer of Pfizer Regenerative Medicine, said in a statement.

Pfizer said that its stem-cell R&D program has three components: to use human cells as tools in its drug-discovery research; to improve the safety of new treatments; and "most importantly, to move towards cell therapy."

In an e-mail to BTW, McKernan elaborated that Pfizer Regenerative Medicine "bases its stem-cell research and drug-discovery efforts on a full set of drug-discovery capabilities, including in vivo and translational stem cell research, cell and molecular biology, and biological chemistry."

Pfizer launched its regenerative medicine unit in November to explore "an exciting array of promising technologies," McKernan said. "This unit examines novel biologics, small-molecule therapies, antibody technologies, and a variety of cell and tissue replacement strategies."

McKernan added that the unit will grow to approximately 70 colleagues by next year, with efforts focused at two locations: researchers based at the company's Research Technology Center in Cambridge, Mass., will focus on using stem cells to develop therapies for diabetes, she said.

Meantime, scientists at Pfizer's Cambridge, UK, location will focus on age-related and degenerative disorders with "a particular interest in common cellular mechanisms and disorders of the central and peripheral nervous system," McKernan said.

Both locations will achieve their goals "through in-house research and a vast array of alliances and collaborations," McKernan added.

One of those alliances, announced last month, is a research collaboration between Pfizer Regenerative Medicine and the University College London to develop stem cell-based therapies for ophthalmologic diseases (see BTW, 4/29/2009).

Led by Peter Coffey, a professor at UCL's Institute of Ophthalmology, the collaboration will primarily explore differentiating stem cells into retinal pigment epithelium cells to develop therapies for wet and dry age-related macular degeneration and other retinal diseases. Pfizer is providing an undisclosed amount of funding to support the project.

McKernan said that Pfizer's deal with WARF "does not preclude" the company from exploring a research collaboration with Thomson or another researcher at UWM; however, the recently announced agreement is strictly a licensing deal, she said.

In a statement, Carl Gulbrandsen, managing director of WARF, said that the organization was "pleased to enter into this licensing agreement with Pfizer," whose "access to this key intellectual property may have far-reaching benefits for both public health and Wisconsin's growing biotechnology industry."

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