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Biotech / Medical : Biotech Valuation

CRSP 57.37

+0.9%

3:59 PM EST

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To: Biotech Jim who wrote (8366)	5/15/2003 11:09:45 AM
From: Biomaven	Read Replies (1) of 52153

BJ, I wonder if the FDA might show some more flexibility here going forward. Traditionally they have had a strong bias against any sort of combination drug. Not only do you have to show efficacy for each drug separately, you have to show improved efficacy over the individual components. Moreover, the FDA has required extended combination studies even when each individual component is an already approved drug and there is no indication at all that the components interact in any weird way (Pozen's migraine combo is a good example). The problem in cancer is that inhibiting just one growth factor may not do much if there are others able to take its place. Thus it might be hard to show efficacy for the individual components. Incidentally, speaking of combination therapy in cancer, I finally saw a theory why Iressa might not have worked in combination therapy. The notion was proposed by an Iressa AC member and reported in Biocentury. It is simply that the chemo drugs work on dividing cells, while Iressa stops cells dividing. I'm not sure I'm really convinced - if Iressa was really stopping the cell division then the tumors wouldn't be progressing, but perhaps it is part of the answer. Peter

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