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

To: NeuroInvestment who wrote (7575)	12/20/2002 3:43:06 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Harry, Ocinaplon is being developed and tested in a time-release reformulation, which they believe improves pharmacokinetics and gives them patent protection beyond 2007--and no generics maker is going to run Phase II and III on original ocinaplon. As I responded to Wilder, once there is no composition of matter on Ocinaplon, then I don't see what would stop a generic maker using their own time release technique and filing an ANDA claiming equivalence. That way they wouldn't need to run trials with the original Ocinaplon. (I'm just speaking off the top of my head here - I've never researched this question). On bicifadine, I guess the strategy you have outlined might work. There will always be some risk of a generic challenge, though, so you have to discount the compound to some degree. Do you have any idea of how bicifadine works? I haven't seen any discussion of this at all. There's a couple of 20-year- old abstracts on PubMed that don't give any clue, and a slightly more recent one that in passing indicates it may be have serotonin reuptake inhibitor activity, which doesn't exactly square with being an analgesic. (Of course I quite understand if you prefer to keep any insights on this for your most excellent publication). Peter

To: NeuroInvestment who wrote (7575)	12/20/2002 8:13:56 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 52153

Harry, First thanks for respond on Rick's questions. Regards the Ocinaplon and Bicifadine IP right I share Peter’s view. Ocinaplon: Time release formulation can be develop in many ways. ELN has patent protected nanotechnology/controlled-release technology in their formulation, but generic only need to show in pharmacokinetic trial that their formulation is bio-equivalent. Patent for O mechanism? This is new and hope it works. Bicifadine: <<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)>> If crystalline form is necessary for dosage formulation and to prepare specific crystallinity one need to run process chemistry than it is valid claim. However, if other forms (alternate crystalline structures) spontaneously and immediately degrades to most stable form that is not valid invention. NBIX IP strength is not in crystalline structure, it is in composite patent. I spent +6 months searching old Cyanamid-AHP patents and never identified Indoplon (by full structure) to be claimed. Miljenko