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Zalicus Inc. Message Board

biobetter2 8 posts  |  Last Activity: Dec 17, 2014 9:57 AM Member since: Aug 17, 2005
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  • Reply to

    nice move up this morning

    by spook2b Dec 17, 2014 9:43 AM
    biobetter2 biobetter2 Dec 17, 2014 9:57 AM Flag

    ASPX's success with their deuterated drug is the news. A rising tide also lifts CNCE's deuterated boat.

  • Reply to

    Question for OTF

    by brian.196610 Dec 9, 2014 11:00 AM
    biobetter2 biobetter2 Dec 10, 2014 1:01 AM Flag

    The half life question appeared on JAZZ's Q3 call. I agree with you that if there was a problem with a morning drowsiness then you would not take the dose higher. JAZZ wants to get rid of Xyrem's bid dosing but the fear of am hangover effect may have caused CNCE to cautiously underdose 386.

    Our next question will come from the line of Bill Tanner from FBR Capital Markets.
    "I had one follow-up maybe, Jeff, for you, just on 386. I mean, I know the trial was intended to measure the PK profile and safety. So let's say, it's safe. Is there a bogey as it relates to the half-life, I guess, that one would need to see to take it forward? Is there any analogue, any observation from Concert as it relates to other compounds, what they see with extended half-life?"

    Jeffrey K. Tobias - JAZZ CMO and Executive VP of R&D
    So, yes, the bogey for 386 is any number of them, if possible, but the one that first comes to mind would be if, indeed, the half-life is too long. So you end up with a product that has effect going into the warning,(Warning may = Morning) and that could be problematic with the product."

  • biobetter2 biobetter2 Dec 2, 2014 11:46 AM Flag

    I agree its cheap but management may be influenced by potential huge option gains. This stock was under $3 a year ago. The FDA just gave AVNR a CRL so that would normally cause the stock to go down. Without the buyout feelers AVNR would probably be selling for under $11.

  • Reply to

    and as for xyrem their narcolepsy drug.

    by ngpharm1 Sep 7, 2014 11:25 PM
    biobetter2 biobetter2 Nov 7, 2014 12:45 PM Flag

    Xyrem is sold only thru specialty pharmacies. Like the blockbuster MS drug Tysabri most RPHs will never ever see a rx for Xyrem unless they happen to work at one of the few pharmacies allowed to dispense it. Xyrem's sales have been climbing and presently are running at a $800 million rate.

  • Reply to

    Patent Issued

    by zwerp2000 Nov 4, 2014 11:34 AM
    biobetter2 biobetter2 Nov 4, 2014 1:40 PM Flag

    This could be important. Roger Tung the ceo of CNCE, used to be the guy in charge of developing Vertex's Kalydeco for cystic fibrosis. That drug is the main reason why VRTX's stock currently has a $26 billion market cap. Vertex's HIV and HEPC drugs were quickly surpassed by the competition. But Kalydeco is a life saving drug that has changed Vertex future. Now VRTX trying to expand the small segment of CF patients where the drug has shown a strong effect. So Vertex is trying a lot of combos with Kalydeco (Ivacaftor in this patent). Also this drug costs over $300,000! So if CNCE can discover a deuterized version that lasts just a little longer than the cost savings alone could be very valuable. Could force VRTX to sign a Revlimid like deal that was done with Celgene. A lot depends on VRTX's patents but with Tung's past VRTX history he should know better than most if VRTX left a deuterium loophole for CNCE. CELG had patented deuterized versions of Revlimid but CNCE had received their deuterized patent before CELG. Below from patent:

    Data Analysis:

    The in vitro half-lives (t.sub.1/2 values) for test compounds were calculated from the slopes of the linear regression of LN(% parent remaining) vs incubation time relationship: in vitro t.sub.1/2=0.693/k, where k=-[slope of linear regression of % parent remaining(ln)vs incubation time]

    FIG. 1 shows a plot of the percentage of parent compound remaining over time for Compound 110 and for ivacaftor in human cytochrome P450-specific SUPERSOMES.TM.. The t.sub.1/2 values, and the percentage increase (% .DELTA.) in average t.sub.1/2, are shown in Table 4 below.

    Table 4 shows that Compound 110 has a 55% longer half life in the assay than ivacaftor.

    Example 6b

    Evaluation of Metabolic Stability of Compounds 105 and 106--Human CYP3A4 Supersomes.TM.

    Data Analysis:

    The in vitro h

  • Reply to

    Potential Indication - Depression?

    by hubb8281 Oct 12, 2014 1:15 PM
    biobetter2 biobetter2 Oct 12, 2014 1:54 PM Flag

    Trazodone is a popular anti-depressant with the elderly. Like Pima its a good 5ht2a blocker. At low dose it is thought the 5ht2a antagonism acts as a sleep aid and the higher dose is used for depression. But Trazodone hits a lot of other receptors at the high dose which contributes to the antidepressant effect. Imo sleep maintenance in CNS diseases and ADP are more likely indications for Pima then depression.

  • biobetter2 biobetter2 Oct 6, 2014 3:43 PM Flag

    California Stem Cell Report asked the company for comment. Ken Stratton, general counsel, responded. Here is the text of his reply.
    “As you know, StemCells, Inc. is engaged in the research and development of cell-based therapeutics and is currently sponsoring clinical studies of potential therapies for spinal cord injury, AMD and pediatric neurological disorders as well as conducting pre-clinical studies in Alzheimer’s disease. The pre-clinical AD studies, but none of the clinical studies, are partly funded by CIRM.
    “The Company has reviewed the complaint filed by Mr. Williams, a former employee whose employment was terminated for performance deficiencies, and finds no merit to the allegations. The Company has retained Littler Mendelson as its litigation counsel and intends to defend itself vigorously in court.

    “You should know, the elements of manufacturing practices that concerned Mr. Williams were immediately and carefully reviewed by the Company. The Company’s primary concern has always been, and will continue to be, the safety and tolerability of stem cell transplantation in its clinical trials. Over the years, we have consulted with multiple experts in the field and we believe our processes, procedures and controls, as fully described in our regulatory filings, are appropriate for a company at our early stage of clinical development and comport with applicable guidelines and regulations. To date, no patients participating in the Company’s clinical studies have experienced any product related safety concerns.

    “We hope you find this information helpful.”

  • Reply to

    About the pipeline of ACADIA

    by acadianwarriorxx Sep 27, 2014 11:14 AM
    biobetter2 biobetter2 Sep 27, 2014 12:47 PM Flag

    Pima for PDP is in the bag but the ADP indication is the best prospect in ACAD's pipeline. Sleep maintenance in CNS diseases could end up being Pima's largest indication but ACAD will 1st target the smaller sleep maintenance in parkinson's. Schizo could be a huge but the odds are far less favorable imo than for sleep and ADP. Allergan will probably give back to ACAD the pain and glaucoma drugs because Valeant is forcing them to cut their R&D. I have lowered my opinion on the Erbeta and NURR1 preclinicals because neither has yet advanced into a P1.

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