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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?

To: Biotech Jim who wrote (775)	7/18/2001 7:53:49 AM
From: rkrw	Respond to of 1834

FYI: Link to the archived conference call at NBIX website: neurocrine.com

To: Biotech Jim who wrote (775)	7/18/2001 11:09:51 AM
From: keokalani'nui	Read Replies (1) \| Respond to of 1834

Jim: The company was asked a question what competing compounds were in human trials. With a laugh--and with great accuracy I suspect--the nbix speaker said he hoped and expected the analysts to have a better idea than he. Then he mentioned only the two, TAK’s melanacortin analogue and Z. It was a meek answer to a throw away question. There was no mention of the age range in this recent study. There was I thought an acknowledgement of future age range-bound studies for elderly and young adults to nail down dosing. I am overweight this one myself. Would appreciate learning if you ever lose your long term enthusiasm for it. Wilder

To: Biotech Jim who wrote (775)	7/27/2001 2:25:59 PM
From: Biomaven	Read Replies (1) \| Respond to of 1834

"TAK’s melanacortin analogue" Sounded to me like he said "Takeda's melatonin analogue." One point about SEPR's S-Zopiclone. Note that the isomer that SEPR is developing has a half-life shorter than the other isomer. According to the following abstract, the elimination half-lives are 225 minutes (the SEPR version) and 399 minutes respectively. Zopiclone (the racemic mixture that is used in Europe) is usually described as having a 4-5 hr half-life. So the SEPR drug should have a half-life somewhat shorter than Zopiclone. The NBIX drug, with it's 60-90 minute half-life, is still better, assuming they can get the modified-release version working correctly. Interestingly Sonata (zaleplon) has only a 1-hour half-life and has not done well in the market, perhaps because of its short duration of action. So too short a half-life can be a mixed blessing. (The dominant player, Ambien, has a 2.5-3 hour half-life). But note that Sonata, even with its 1 hour half-life, showed residual sleepiness after 4 hours, perhaps indicating a dose-response curve that doesn't tail off quickly enough. I don't recall that SEPR itself has addressed the half-life issue, although they do seem to be planning two dosage versions which suggests a good dose-response curve and a manageable half-life. They claim no residual effects on wakening, although they haven't talked about middle-of-night dosing. In terms of timing, SEPR has about a 2 year lead. However clearly there is going to be lots of room for the NBIX drug if it fulfills its present promise. (Both SEPR and NBIX are major holdings for me). Here's the abstract I was referring to: Drug Metab Dispos 1993 Nov-Dec;21(6):1125-8 Related Articles, Books Pharmacokinetics of zopiclone and its enantiomers in Caucasian young healthy volunteers. Fernandez C, Maradeix V, Gimenez F, Thuillier A, Farinotti R. Hopital Pitie Salpetriere, Service Pharmacie-Pharmacocinetique, Paris, France. The disposition of the enantiomers of zopiclone and its two chiral metabolites was investigated after oral administration of a single dose of 15 mg of a racemic mixture (twice the usual therapeutic regimen) in 12 adult Caucasian volunteers. Determination of concentrations of zopiclone enantiomers in plasma showed that zopiclone pharmacokinetics is stereoselective with AUC0-->infinity values of 691.3 and 209.5 ng.ml-1.hr (p < 0.001), Cmax values of 87.3 and 44.0 ng.ml-1 (p < 0.001), oral CLtot/F values of 195.5 and 659.8 ml.min-1 (p < 0.001), Vd/F values of 98.6 and 192.8 liters (p < 0.01) and elimination half-life of 399.2 and 225.6 min (p < 0.01) for (+)-zopiclone and (-)-zopiclone, respectively. On the contrary, absorption half-life and Tmax values were not significantly different. In 48-hr urine, 3.6% of unchanged zopiclone was excreted, whereas 14.2% and 13.8% of both metabolites, N-desmethylzopiclone and N-oxidezopiclone, respectively, were found. Quantities of (+)-zopiclone excreted in urine were always higher compared with its antipode (-)-zopiclone for the 12 volunteers (p < 0.001). For the metabolites, quantities of both enantiomers were either equal or different and when different, it was always in favor of the (+)-enantiomer. Peter