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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (6195)	12/28/1998 4:15:00 PM
From: Biotech Jim	Respond to of 9719

<The EPO trial is fully in HMR's hands, so you will not see clinical data (if that's what you were asking for).> I was not looking for the clinical data, as I'm sure that these will not be disclosed for obvious reasons. What I was interested in was the specific details as to how the EPO gene was turned on. Its one thing to do it via in vivo engineering, in which there could be significant side effects (in addition to issues related to in vivo manipulation of genes, also related to chronic loss of receptor responsiveness due to a variety of desensitization mechanisms). If the protein was expressed in cells "ex vivo", I would still be interested in the specific details as to how the EPO gene was turned on. I was not aware of the multiple protein products that TKT had an interest in. Thanks, and I guess it's time to read a few more 10q's. BJ

To: rkrw who wrote (6195)	12/28/1998 5:16:00 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 9719

>> I've been told by TKT that HMR licensed the CEGE patents to cover all angles, however the technology is not being used for it << I believe you, of course, but I'm not certain that I believe the person that you were talking to. From my first-blush look (about 1 1/2 years ago), I got the distinct idea that the breadth of the CEGE claim did cover methods that were used to construct the TKTX cell line, and that TKTX had used YAC libraries. Haven't seen anything since that convinces me otherwise, and Hoechst wouldn't give away even a low, single-digit royalty without plenty of study. The question of whether or not TKTX is infringing AMGN is another issue, however, and will boil down to definitions of "heterologous", "exogenous", etc. and to the bucks thrown at attorneys. My very preliminary view is that TKTX does not infringe, and that anything that is produced in a heterologous host and where composition of matter is not available is free for the picking. BJ.... sorry, but I misunderstood one of your earlier questions..... the first claim of the patent clearly covers in vitro production from mammalian cell lines. Since you mentioned FSH (imagine you've seen this, from the CEGE 10-K)........ In February 1997, Cell Genesys executed a license agreement with Hoechst Marion Roussel for erythropoietin and a second, undisclosed protein. The agreement provides for up to $26 million in milestone payments and fees, in addition to any royalties on future sales of these two potential gene-activated protein products. Cell Genesys has earned $5.1 million through December 31, 1997 under this license. In February 1994, Cell Genesys signed a licensing agreement with Theriak A.G., a subsidiary of Akzo Nobel N.V. ("Akzo Nobel"), to develop and market Cell Genesys' therapeutic protein product, gene-activated follicle stimulating hormone ("FSH") for the treatment of infertility. Akzo Nobel was granted worldwide rights to develop and market gene-activated FSH in exchange for licensing fees, royalties and other payments to Cell Genesys. During 1995, Akzo Nobel settled a patent dispute with another party related to recombinant FSH and is now marketing this form of FSH subject to regulatory approval. Cell Genesys has received $8.1 million in payments under the agreement and a 1996 amendment.