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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?

To: Thure Meyer who wrote (1067)	4/4/1999 6:33:00 PM
From: OpusX	Read Replies (1) \| Respond to of 1837

anda's are abreviated new drug apps used to get fda approval for generic drugs in this case cenestin was origainally submitted to the fda as a generic equivalent to premarin this is where the $ is when wyerth ayerst blocked them they went back to the drawing board and now have applied an nda for a brand name drug for the same molecular entity less lucrative unless md's will start to write for it.

To: Thure Meyer who wrote (1067)	4/4/1999 9:40:00 PM
From: tommysdad	Read Replies (1) \| Respond to of 1837

Well, I know you weren't, but two other guys were. Taxol and Tamoxifen, both used for breast cancer, easy to confuse the two. I'm betting DRMD won't even take the "new, improved, purer" Tamoxifen forward themselves. It has been known for some time that both isomers of Tamoxifen are estrogen modulators; the side-effects of the minor isomer are known but I don't know them off the top of my head. I would look for DRMD to attempt to sub-license this to Zeneca, much the same way Sepracor has made a very nice business holding Big Pharma over the barrel with various "new, improved, purer" forms of various drugs (recently, Prozac and Lilly). I think this would be a harder sell to go alone because the minor isomer is so very minor (<4%, I believe), rather than the 50:50 mixtures Sepracor tends to target. Certainly could'nt go the ANDA route (the whole point is, it's purer). But Zeneca could sub-license and essentially extend it's own patent life -- but they have a "pure" anti-estrogen (that is, pure anti-estrogenic activity vs. a pure chemical) in development and may not be interested. I wouldn't attach too much value to this potential product at this time -- too many unknowns.