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

To: Biomaven who wrote (23492)	4/18/2007 3:50:23 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 52153

>> rather than a better drug << Which is not a "me too" drug. >> "first or second across the line takes all" << Neither Harry nor I are making the argument that you're implying has been made.

To: Biomaven who wrote (23492)	4/18/2007 4:08:04 PM
From: NeuroInvestment	Read Replies (1) \| Respond to of 52153

Peter: All good points. But I would never suggest 'first or second' across the line as the limit anyways. I'm not sure where I'd draw the line, which is why am I am reluctant to have the FDA doing it. Where it starts getting absurd is exemplified by the schizophrenia area: Not that there isn't ample room for improvement given Zyprexa's metabolic issues and the general lack of effect on cognitive symptoms, but if you look at Vanda's revived development of iloperidone, all the anticipation that this could be the breakthrough antipsychotic disappeared five years ago. Now they are simply trying to show--and failing to do so--that it might be better than Geodon, another afterthought in the market. The bottom line is that, in the areas I know, most of the choices involve choosing the least mediocre option. And you do have companies doing absurd things (Cephalon wasting time with Sparlon and now Nuvigil, Shire having worked on a sixteen hour duration Adderall XR XR) simply to extend patent turf. The current situation puts more of a premium on DTC budgets, less on aiming for innovation. In your favor is the fact that sometimes, patent-extension ploys end up producing a drug with some unexpectedly distinct differences: Lundbeck developed Lexapro to replace Celexa, but in fact the enantiomer Lexapro has a very different profile for many patients. If there isn't some evidence in Phase IIb that a new drug doesnt have either efficacy or tolerability advantages in at least some significant subgroup (and I realize we are not yet at a point where we can be confident of identifying such subgroups up front), I wouldnt be all that upset if the rule of thumb switched from 'so long as it is close to those ahead timewise' to 'let's try something new.' My perspective is of course skewed by having watched so many micro and mini programs struggle to stay alive while trying to figure out if their innovation even had merit, for lack of BP funding. There is no doubt in my mind that there have been worthy technologies in CNS that have been set back five years or more due to BP's allocation of resources to that which is familiar. Harry NeuroInvestment