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  • Arena Spikes On Pipeline News [View article]
    Sorry Jim, wrong drug.

    APD334 is a follower compound to Gilenya, which causes rapid drops in heart rate in some people. Its uptake has been slowed in part by the inconvenience to prescribers of having to keep patients under observation in their office for several hours after adminstration of the first dose.

    Backups drugs in development are able to use drug titration to avoid this.

    ARNA claimed yesterday that they saw no cardiovascular effects for APD334, but in a press release from an earlier Phase 1 trial they said that it had CV effects "similar to those of other drugs in its class". So its not clear what is going on at this point.

    Its possible that ARNA actually has a S1P1 comopund w/o CV issues here. But good to bear in mind that this is the company that did not think preclinical carcinogenicity studies that held up approval in the US by a year and prevented approval in the EU were "material" enough to disclose.

    So on the whole, I'd see this as a selling opp.
    Jan 8, 2015. 10:44 AM | 2 Likes Like |Link to Comment
  • Arena Spikes On Pipeline News [View article]
    Well, it does take me time to figure stuff out, but the stock is down 12% today and continuing to fall as I write this. My recommendation has not changed.
    Jan 8, 2015. 10:41 AM | 1 Like Like |Link to Comment
  • Arena Spikes On Pipeline News [View article]
    So I count one approved compound with the same MOA but having CV issues, one same MOA competitor in Phase 3, and 4 same MOA competitors in Phase 2. Nonetheless, the market cap jumps by $400M on a Phase 1 result?

    This may be a good opportunity for some folks to reduce their exposure to a company whose share price has been in a long term downdraft for over a year.
    Jan 7, 2015. 01:27 PM | 1 Like Like |Link to Comment
  • Arena: Belviq Sales See Pleasant Rebound [View article]
    The U.S. market isn't that relevant, Roche sells less Xenical here than they do in Britain. What is critical is that there are no generic weight loss drugs in the EU.
    Dec 20, 2014. 09:37 AM | 4 Likes Like |Link to Comment
  • Arena: Belviq Sales See Pleasant Rebound [View article]
    Spencer, OREX received a positive CHMP vote today, and so compared to ARNA and VVUS, uniquely has access to the market where 60-70% of Meridia and Xenical sales occurred (presumably due to absence of competition from phentermine). The enterprise values of OREX and ARNA are fairly similar. Any reason you are aware of that one should be holding ARNA at this point, or is it completely dominated by OREX?
    Dec 19, 2014. 12:45 PM | 1 Like Like |Link to Comment
  • What Biogen Idec's Alzheimer's Candidate Could Be Worth [View article]
    I share your skepticism, but 99.6% failure rate? At least 3 AD drugs have been approved, so there would have to have been 750 completed interventional Phase 3 trials in AD total. Clinicaltrials.gov shows 109.
    Dec 5, 2014. 05:22 PM | 1 Like Like |Link to Comment
  • ISIS Pharmaceuticals: Finally On Target After All These Years [View article]
    Sorry for the slow response. I'm not quite as on top of all the details of RNA technology as I am for antisense. Dirk Haussecker knows a lot more about that than I do, his blog is here. http://bit.ly/QfCRsI

    My understanding is that efficiency of delivery is very important, and that the more complicated systems used by Tekmira and Arrowhead serve to keep the cost of goods down (its still pretty high, the main cost being RNA with unnatural bases) and limit toxicity associated with off target oligo interactions with toll like receptors and the like one sees at higher doses.

    The Tekmira and Arrowhead delivery particles offer the potential for directing delivery to other organs by attaching ligands to the surface, though its all early stage at this point. The ISIS statement "distributes in a manner similar to our second generation drugs" seems to me to be a roundabout way of saying they pretty much end up in the liver.

    But I'd definitely suggest a look at Dirk's site.
    Apr 17, 2014. 02:47 AM | Likes Like |Link to Comment
  • ISIS Pharmaceuticals: Finally On Target After All These Years [View article]
    You should be able to see the article here: http://bit.ly/1jF2g8s

    If not, you can get it from my skydrive account here:
    http://1drv.ms/1htRFAg
    Feb 18, 2014. 11:16 PM | Likes Like |Link to Comment
  • ISIS Pharmaceuticals: Finally On Target After All These Years [View article]
    Well, there's momentum and there's intrinsic value. They all seem to have a lot of momentum, so it depends on if you are a trader or investor I guess.

    From the investing POV, what worries me about the ISIS portfolio is that to some degree, they all are likely to show the same thiophosphonate backbone-related toxicity: Effects on activation of the alternative complement pathway, prolongation of the activated partial thrombplastin time, and thrombocytopenia. The gen 2.5 compounds might be better by being more potent and thus more specific, but on the other hand similar looking compounds from Enzon (locked nucleic acid) have in some cases shown hepatotocity. So I worry that a lot of these very promising looking Phase 2 results in indications for which safe drugs already exist will evaporate in Phase 3 when tox raises its ugly head. They would do well I think to focus on life threatening diseases for which there are no good treatments.

    I currently own both ARWR and TKMR, ALNY seems expensive to me. I am not at all sure that the currently targeted disease states make sense (I don't think ARC 520 will do that well in Phase 2 for HBV), but in the long run this technology will be important. And in the short run there is a lot of momentum, though one might want to move in and out in order to take full advantage of what I expect to be a lot of volatility.
    Feb 17, 2014. 11:35 PM | Likes Like |Link to Comment
  • Orphan Drug Designations: Why You Should Care [View article]
    BioMedTracker has now made the full report by Jolene Lau that this article was based on available for free download.

    http://bit.ly/1bBFQ1h
    Dec 13, 2013. 11:54 AM | Likes Like |Link to Comment
  • Orphan Drug Designations: Why You Should Care [View article]
    Hi Dharma,

    Thanks for the comment. We took our data from the BioMedTracker database which is pretty comprehensive post-2005. I think the apparent discrepancy may just be due to differing methodology and what "counts" as a rejection.

    The BioMedTracker analysis considers NDA decisions "unresolved" until the company abandons the drug, even if a CRL is issued. The total NDA approval rate includes drugs that were approved on second, third, or even fourth review. A summary of the results can be found here: http://bit.ly/Z0RmNn on about the 10th slide.
    Dec 12, 2013. 01:11 PM | 1 Like Like |Link to Comment
  • Orphan Drug Designations: Why You Should Care [View article]
    Thanks Atrickpay. That search was my responsibility and I missed this.

    In my defense, the drug name is misspelled in the FDA database of orphan drug designations, and the disclosure by the company is buried at the bottom of a press release dealing with a separate issue.

    Good find on your part.
    Dec 12, 2013. 01:02 PM | 3 Likes Like |Link to Comment
  • Quick Take On Geron's Imetelstat Abstract [View article]
    Well damn, that comment was a little late!

    http://mayocl.in/1bla6Sq

    Interesting result. Don't think I've seen a positive result in bone marrow for an oligio before.
    Dec 6, 2013. 01:29 PM | Likes Like |Link to Comment
  • Quick Take On Geron's Imetelstat Abstract [View article]
    I think the problem is that cell culture is not the in vivo environment. You can put the drug into a 96 well plate and it has two choices: Go into the cell or stay in the extracellular solution. And no matter how slowly it enters the cell, it really isn't going anywhere.

    Contrast the situation in an organism, in which most oligionucleotides make a beeline for the liver and kidneys. They sit in those organs until they are exceted in the urine or feces or metabolized to inactive fragments.

    If you could soak the spleen and bone marrow in a 200 nM solution of imatelstat 24 hours a day, I think your extrapolation from the cell culture experiments would be strictly valid. Unfortunately, that's not possible.

    The observation of thrombocytopenia may be a promising sign to the extent that it suggests bone marrow penetration is occurring. But as Patrick pointed out, there seems to be a lot of ambiguity in the in vivo results to date. I think we still need to wait and see.
    Dec 6, 2013. 12:53 PM | Likes Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    It that settled at this point? Last I saw it was ambiguous.
    Dec 5, 2013. 09:56 AM | Likes Like |Link to Comment
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