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

To: NeuroInvestment who wrote (7581)	12/21/2002 11:50:14 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 52153

Harry: >> But if so, that is an alternate hypothesis to 'they were lucky' << He's not saying that they weren't skillful. He's saying that they were fortunate that the structure isn't one of many described "shotgun" by Wyeth. You're both correct. CRF..... drool. Thanks for the update. sustained release...... >> If it is in fact so easy to devise an alternate time-release technology that does not infringe, but provides identical bioavailability and pharmacodynamics/kinetics << But is that necessary? I don't understand why an alternative TR formulation would not be acceptable to FDA. You're saying that a "generic" competitor would need to go back and do phase I and II testing, and that would be a daunting hurdle. But that's in a context where those trials would be followed by a large, risky phase III?? 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? rkrw knows a lot about this sort of stuff, no?? I don't, and I'm just offering my thoughts up as fodder. Make me look silly, make me wealthy. :-) bicifadine...... this is important, obviously. As you indicated, the acute dental pain indication is not the target. >> 2) They have filed for patent on the crystalline structure of bicifadine--and say that any alternate stucture immediately degrades to their's, thus infringing on their patent-pending. (similar to structure strategy successfully used by NBIX on Indiplon) << I believe that you're (mostly) saying that there is a patent strategy in place to keep a generic competitor tied up in court, not allowing them to use DOV/ELN data with the non-TR versions as a part of any submission? 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". :-) Fun/spooky to poke around here...... barbeaupharma.com

To: NeuroInvestment who wrote (7581)	12/21/2002 3:12:42 PM
From: Miljenko Zuanic	Respond to of 52153

Harry, <<3) The question: If it is in fact so easy to devise an alternate time-release technology that does not infringe, but provides identical bioavailability and pharmacodynamics/kinetics (which could be very pertinent to clinical performance)--why would anyone bother patenting time-release technologies in the first place? I personally question whether it is in fact so simple (and free of infringement) to perfectly mimic a patented time-release formulation, and thus it may provide more protection than has been suggested here. Does this make sense to you given your chemistry expertise?>> In my layman view (far from any expertise) it is not easy, and vary from compound to compound. Each compound has its own chemico-physicals properties, so each of them is separate story and should not be generalized. Time-R, Extended-R, Modified-R, Pulse-R, …technologies are science for itself. Today we have huge advance in this field and technology is available to bran and generic companies. To generate two different solid dose formulation (non-infringement) with equal or close to equal bioavailability and pharmacodynamic is not easy, but is not impossible. Recent example is AstraZeneca’s Prilosec, where one generic did generate their own formulation while several others did infringe Astra formulation patent. In many cases, because of the non-perfect copy, generic drugs have lover potency and/or more problems with pts-variation. Another example is Indoplon formulation patent (Campbell). MR formulation was developed in UK, before drug reached San Diego labs. NBIX Indoplon-MR formulation patent covers Sonata. So, can this patent stop ELN in their effort to develop Sonata-MR? I do not think so. <<25. The controlled release formulation of claim 1 wherein the sedative-hypnotic compound is zaleplon. >> DOV/ELN strategy for Ocinaplon may work. I will need to read formulation patent application before generating any opinion. Regards the Bicifadine I am confused with what they are trying to do and where they are now. Bottom line, developing a good copy of the specially formulated drug is not easy. However, giving high $$$ involved here generic will do everything in their hand to prove opposite. And pharma fights back. Miljenko