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Ariad slides again as FDA details adverse event reports

  • Ariad Pharmaceuticals (ARIA -15.1%) takes another big hit on the heels of Wednesday's rout.
  • The FDA posted a drug safety communication on Iclusig today which contained the following rather disconcerting language: "FDA is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking ponatinib ... including heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow." (full report)
Comments (10)
  • let me understand. this drug is given to people who do not have hope of living because of their disease. It works without bad side effects in 80% of the case, develops blood clots, strokes, and other dangerous things in the rest of 20%.

     

    and this is bad? suggest we take a further look at Acetaminophen and NSAIDS closer, too, then. We want a silver bullet I suppose.
    11 Oct 2013, 11:51 AM Reply Like
  • Great point david. In the statement above, there is also no FDA mention of potential for lower dosage solution.
    11 Oct 2013, 11:59 AM Reply Like
  • David, this is all true.

     

    But the competitive context is on safety.

     

    There are other drug in the space, in particular Gleevec (Novartis) that will be generic 4jan15 to be precise. Thus if the tox is somewhat comparable it will be difficult to ask for a premium price.

     

    I was long ARIA
    11 Oct 2013, 12:24 PM Reply Like
  • It is the patent on the principle that expires at that date - the patent for the drug itself expires May 2019. Between 2015 and 2019 you would have to invent and get approved another drug against the target.
    11 Oct 2013, 12:52 PM Reply Like
  • Well, I am not sure as to the meaning of the word “principle”.

     

    The patent (5,521,184) expired on 28may13 and was extended for 586 days under 35 USC 156. The patent is a composition of matter patent or, more plainly said, on the molecular structure and synthesis of the drug active.

     

    So, no new molecule need to be invented here.

     

    Other patents have been awarded on formulations and crystal polymorphs. These types of patents are usually recognised as “weak”: Not only difficult to defend in court but can also be formulated around. Generic manufacturer have a lot of expertise here.
    11 Oct 2013, 09:59 PM Reply Like
  • Thank you for clarifying this.
    12 Oct 2013, 12:46 PM Reply Like
  • Pig--
    Many TKIs available...Gleevec over 10 years old...newer TKIs proving to be more benificial than miracle drug Gleevec...a look at 2nd generation TKI Nilotinib- Novartis follow up to Gleevec...really a shame to hear this news with Ariad!

     

    Long and Crushed by ariad....
    12 Oct 2013, 03:59 AM Reply Like
  • While we are waiting for the drugs to go off patent andbecome generic, folks with no chance of living are not given the chance. It's okay if my long ARIA goes to zero (not really) but to deny a dying person an 80% chance (or better percent if diluted) seems cruel waiting until 2019.

     

    My understanding is that these drugs work by denying the disease of a good blood supply. Hello?? and you wonder whay it forms clots and such? Give me a break, FDA.

     

    They are dead by then with green grass over them...still waiting for the silver bullet. (which isn't EVER coming)
    13 Oct 2013, 08:58 AM Reply Like
  • Long Aria
    13 Oct 2013, 08:58 AM Reply Like
  • Just an interesting side note. I have commented here before that I am having great success on a low dose (15 mg) of Iclusig - the Ariad drug. What I didn't mention is that my leukemia has mutated and I have failed on EVERY ONE of the previous TKI's. Gleevec, Tasignia, Bosutinib, and the other other ones I can't remember (possibily dasatinib), but I was in the clinical trials for all of them. So far the best resultsw, by far, have been on Iclusig. A number of other patients are alson on the 15 mg dose with minimal side effects and incredible response to the drug. I have no other alternative treatments - Iclusig is it. I plan on being here long enough to see a great return on my investment. I hope all the financial pundits and the FDA figure all of this out. At low dose levels, the benefits FAR outweigh the risks - simply put, if I didn't have Iclusig I would not be here writing to you.
    14 Oct 2013, 02:17 PM Reply Like
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