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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (7582)	12/21/2002 1:44:49 PM
From: NeuroInvestment	Read Replies (1) \| Respond to of 52153

Rick: >>Wouldn't it just be a matter of providing sufficient evidence of efficacy in a context where tissue accumulations do not exceed those characteristic of any DOV/ELN formulation?<< But that's the rub--what is sufficient evidence of efficacy? Generally it is Phase III. It would be hard to argue that a different TR formulation was a priori completely equivalent (That's what I think, but also that's what I was asking of MZ, how easy is it?). And by equivalent, I am not just talking tissue accumulation. NBIX has had to run parallel Phase IIIs on Indiplon IR and Indiplon XR. Admittedly, that is because the timing of drug action onset and cessation is so totally critical in insomnia tx. But one can argue that in the case of anxiolysis, the timing of onset and decline of blood levels is also pertinent. A prescriber would need to know that the generic behaves the same as the original in terms of how fast relief begins and how long it lasts, if only to sort out whether to prescribe for qd, BID, or TID dosing. It seems to me the generic manufacturer using a different TR mechanism would have the burden of achieving and proving this. If they can show that the pharmacokinetics are exactly the same, perhaps that would suffice, but that begs the question of how easy it is to do so. If they differ at all, that would leave open the question of whether the profile of clinical effect might be altered. Interestingly, DOV claims that original ocinaplon administration results in considerable variance of blood levels across subjects--i.e. that taking the same dose has very different blood level results in different people, hence complicating its use considerably. They further claim that their particular TR mechanism reduces that variance, so that there is a more predictable correlation between dose and blood level across subjects. That could be another hurdle for a competing TR mechanism to cross--either in the clinic or in court. >> Isn't that, given the current view of patent manipulation (e.g., Waxman-Hatch), a bit risky to invest in? I'm hoping that our new FDA commissioner is charged with responsibility to make good drugs "available cheap", and to recognize innovation and development expense by allowing new, good drugs "available expensive".<< I actually agree with you about the delaying tactics used by pharma to keep generics at bay--a lot of energy and money invested in protecting drugs that are becoming anachronisms. But there are precedents for it, which might make it harder for McClellan or anyone else to change the rules now. Harry NeuroInvestment