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Neurocrine Biosciences Inc. Message Board

  • KTLeyed KTLeyed Jul 12, 1999 12:03 PM Flag

    I don't agree this time...

    Typically, yes this would not be looked as as
    good news, but I know from first hand that their
    altered peptide ligand MS drug works, this will be a
    breakthrough drug for MS patients when it's approved by the
    FDA. There are no side effects and it's only a weekly
    injection unlike the existing ABC drugs that are out there
    now. I think it's good for NBIX that they have
    reaquired the rights, this drug will take off, mark my
    words. Novartis is most likely pulling out for the
    reasons they say, they know just as well as I do that
    this drug is a proven success so far, wait and
    see...keep in mind, FDA approval would not be for another 2
    years at least, they have to complete Phase III first.

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    • Would like to discuss MS with you since your husband and my wife are both afflicted. If your interested, contact me at morel55@yahoo.com. Thanks--Dave

    • I am getting rather concerned. The massive volumes
      the last couple of days and price drop make one wonder ...
      how long ? I'll try and be patient, though !

    • It sounds like if they adjust the dose, they can eliminate these minor side effects. Do they expect these trials to go perfectly, or do they make adjustments along the way?

    • it does seem a little overkill that they are
      halting the trial at this time, my husband has been
      partaking in it, and he was only on it for 6 weeks and was
      told he'd have to stop. (He had no side effects at
      all, except some stinging at the injection site) The
      nurse who told him about it did not sound optimistic
      about it starting up anytime soon, I think the press
      release definately put a positive spin on it, but I don't
      think that's the real story. For all we know, there
      could be more serious reactions that I haven't heard
      about. I may know more after Friday.

    • My wife is on Avonex and has the chills and fever
      reactions and if you look at the side effects of Novantrone
      that is going under expedited review for approval,
      flushing and hives don't seem all that bad.

    • I think it means the hives and flushing that I
      mentioned earlier. In a group of only 155 patients, three
      people have come up with these allergic reactions, in
      that small a group, this is a concern. These people
      had been on the drug for at least 6 mos. I think.

    • I'm not sure this is necessarily bad news until someone can define "systemic hypersensivity" . Comments?

    • I just found out today that Neurocrine is halting
      the Phase II Clinical Trial for APL drug has been
      officially halted. Apparantly some of the patients developed
      allergic reactions to the drug and broke out in hives and
      maybe some other symptoms and they are stopping the
      trial to re-analyze the situation. The official word is
      this has nothing to do with the Novartis pull out. I
      am very bummed by this, I thought this drug was very
      promising and had high hopes for it. Most likely the trial
      will not be started up again for a long time, could be
      years.

      Sorry all of you who were hopeful for an MS
      breakthrough, this is very discouraging. Hopefully something
      else is right around the corner....

    • This drug is being tested on relapsing remitting
      patients, who will naturally have a variable course. Thus,
      it would be difficult to unblind the study. It is
      also not clear what side effects may be experienced --
      one of the potential benefits of the NBIX treatment
      over interferon is that it is apparently well
      tolerated, and requires much less frequent
      dosing.

      There is much hope in the MS community that this will
      be a hit. Of course, those hopes have been dashed
      many times before. Connetics had a peptide vaccine
      technology similar to the NBIX product that it abandoned
      before stage III, despite evidence of efficacy. They
      chose to develop products that were directed for a
      larger market (such as psoriasis.) Avonex is an OK drug
      but there is lots of room for improvement in efficacy
      and tolerability. If the NBIX drug proves safe and
      effective, it is only a question of effective marketing to
      displace Biogen. Of course, these are big "ifs" and we are
      at least several years from seeing it go to market,
      should it so merit.

    • Neither NBIX nor Novartis have access to the 144
      pt Phase II trial MRIs being done in Montreal.The
      NIH trial is open, and conceivably they could try to
      interpret the MRI data. Problem is...trying to determine
      what fluctuations reflect drug effect, vs. the
      fluctuating course of nonprogressive type MS. Thus I do not
      think it the decision necessarily reflects any
      solid...or even gelatinous, 'feel' on Novartis' part---other
      than if the drug completely wiped out lesions, that
      would have been evident. Anything 'in between' (e.g.
      approximating the effect of Avonex and its ilk, or even
      somewhat better) would be difficult to discern.
      NeuroInvestment (www.neuroinvestment.com)

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