By Frances Bishopp
Genetics Institute Inc. (GI) has added a fifth corporate participant to its DiscoverEase program, GI's protein development platform.
Bayer Corp., of Pittsburgh, has signed on with GI, a subsidiary of American Home Products Corp., of Madison, N.J., in an agreement that gives Bayer access to GI's library of expressed, human secreted proteins and a corresponding database of information for the identification and development of human therapeutics.
Bayer joins Chiron Corp., of Emeryville, Calif., Genentech Inc., of South San Francisco, Kirin Brewery Ltd., of Tokyo, and Ontogeny Inc., of Cambridge, Mass, in GI's line-up of corporate participants.
In June 1997, less than four months after receiving an initial plate of proteins, Ontogeny identified a potential protein and took out an option to exclusively license it for further development, the first company of the group to do so.
The DiscoverEase library is available to commercial and academic researchers on a non-exclusive basis, Adelene Perkins, business director of DiscoverEase at the Cambridge, Mass., company, told BioWorld Today. Any participant who pays the initial fee, which Perkins described as modest, may order and receive the 96-well plate and protein and cDNA samples.
If a protein is identified, an exclusive option is taken to continue the evaluation of the protein. At the end of the option period, if the partner decides to license the protein, GI will assess a licensing fee.
At the time of the initial new drug application (IND), GI will decide if it will retain rights to codevelop and co-market the products. "At that point, we will be in a true 50/50 arrangement where there is an equal sharing of the costs of development as well as the profits," Perkins said.
There is no charge for academic investigators to access the DiscoverEase library, and some 25 researchers from various academic institutions around the world currently are participating in the program.
DiscoverEase employs two technologies to identify secreted proteins: the Signal Sequence Trap, which is a yeast selection for identifying human cDNA encoding secreted proteins; and the 5 Prime technology, developed by Genset S.A., of Paris, which uses the technology to develop its SignalTag library.
Earlier this month, GI entered into a $20 million agreement with Genset S.A., of Paris, which calls for Genset to provide, on an exclusive basis, full-length genes encoding novel human secreted proteins from its SignalTag library to GI, which will express those genes and include those proteins in its DiscoverEase protein development platform.
Perkins said the DiscoverEase library, which was launched in 1996, offers approximately 300 proteins and, within the next several years, hopes to have a library comprising of at least 5,000 entries. Perkins said GI believes there are between 5,000 and 10,000 secreted genes.
In the next five years or so, most of the secreted proteins will be known, Wolf-Dieter Busse, senior vice president, biotechnology, at Bayer's Berkeley, Calif., operation, told BioWorld Today. Since all proteins will be known in five years, he said, it is a race not only among GI's customers, but among their competitors.
"The question now is how to exploit and use this information. There are at least 100 diseases for which protein drugs may be useful, rather than small molecule chemical drugs," Busse said. These diseases are characterized by high-medical need and a very specific biological approach. Protein drugs are expensive drugs and lend themselves to exploit the technology that GI offers, Busse said.
Without identifying specifics, Busse said Bayer will look for products in the areas of fibrotic diseases, stroke, cancer, cardiovascular disease and the central nervous system.
Also on Thursday, GI reported it had purchased the development and commercialization rights to Pharmacia & Upjohn's Refacto product, recombinant Factor VIII, for the treatment of hemophilia A.
Refacto, currently in Phase III clinical trials in Europe and the U.S., is not only recombinant, but is formulated without albumin for an added measure of viral safety.
Under the terms of the agreement, Pharmacia & Upjohn, of London, will perform selected development activities and will manufacture ReFacto for GI. Pharmacia & Upjohn will also have rights to copromote ReFacto in the Nordic area and the Middle East. Financial terms of the agreement were not disclosed. *