Summer Street not giving up on Ariad's Iclusig despite suspension


With shares of Ariad Pharmaceuticals (ARIA -42%) trading sharply lower on news of a marketing and commercial distribution suspension for Iclusig, Summer Street's Carol Werther is taking a glass is half-full approach.

"We believe that ARIA will ultimately re-define the label and re-introduce the product with a REMS," Werther says, adding that Summer Street is "more positively inclined ... on ARIA-FDA taking the situation head on, as the drug has an important place in salvage CML."

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Comments (8)
  • 208Pb
    , contributor
    Comments (24) | Send Message
     
    Some readers may remember the TYSABRI story; following news of patient deaths the drug distribution was suspended. The story may be a good comparator for timing purpose.

     

    Here is the TYSABRI time line

     

    February 28th 2005, the drug commercial distribution was suspended

     

    July 24th 2006, the drug became available again but with a substantial risk management plan and new label

     

    So, 17 months.
    TYSABRI is a Biogen drug for MS
    31 Oct 2013, 04:02 PM Reply Like
  • dhdhoora
    , contributor
    Comments (747) | Send Message
     
    The 17 months sounds about right and is pretty discouraging. Given the importance of Iclusig -- and its orphan status -- I personally did not see the full suspension. I'm not sure why this wasn't decided when the decision was made to stop the EPIC trial. What could have changed in a few weeks?

     

    Anyway, resources are going to be stretched and I suspect that they will have to suspend other trials and have some staff layoffs to get through this. Or, throw themselves on the market at fire sale prices..

     

    All the very best,
    Don
    31 Oct 2013, 06:06 PM Reply Like
  • TruffelPig
    , contributor
    Comments (4203) | Send Message
     
    They should focus only on the most pertinent trials now at reduced dose and with blood thinner. They will probably have to run a new phase II I guess.

     

    Maybe since it is an orphan drug and there is nothing that can help the patients it could take less time for FDA than 17 month?
    31 Oct 2013, 09:49 PM Reply Like
  • david roper
    , contributor
    Comments (76) | Send Message
     
    Man oh man, people for sure dying with NO hope and along comes a drug with death as a 20% chance, 80% cure.

     

    If YOU had cancer (leukemia) and could be offered that bet with those odds, would you take it? I would. Death is sweet but living is better.

     

    Relabel it and get on with its marketing. Folks are dying.
    1 Nov 2013, 06:22 AM Reply Like
  • TruffelPig
    , contributor
    Comments (4203) | Send Message
     
    Adam Feuerstein from Street cites a still around 160 million/year market potential - even under current circumstances. This obviously could get better if low dose works on other cancers or when co-administering blood thinners etc. It is also not the sole drug in the pipeline. $ARIA is valued here as having 0 drug....nada....forever. There are companies with higher valuations in the biotech space that work on fruit flies.........
    1 Nov 2013, 08:59 AM Reply Like
  • 208Pb
    , contributor
    Comments (24) | Send Message
     
    Here is a quote from the USFDA statement on the issue:

     

    “Patients who are currently taking Iclusig and responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues. FDA will work with the manufacturer on a plan to quickly transition these patients to a program that will allow access under an IND or expanded access registry program”
    So from a patient perspective not all is lost.

     

    Also from the same USFDA statement we learn that in a Ph1 with patient median duration of 2.7 years, 48% of patient had “experienced serious adverse vascular events”, there are more details in the statement.

     

    It seems fair to say that in general the toxicity appear to be proportional to duration and dose.

     

    From a shareholder perspective, this is bleak.
    I was long Ariad.
    1 Nov 2013, 11:29 AM Reply Like
  • loganj2
    , contributor
    Comments (44) | Send Message
     
    The low dose therapy is highly effective with very minimal side effects. I have been on this treatment for two years and 4 months. Originally started at 45mg and after 1 month had adverse side effects (pancreatitus), the dosage was cut to 15 mg. Within 1 month the leukemia was undetectable and has stayed that way. This is a far better response than I had on any of the other TKI's either in development or FDA approved. Not only did every other TKI lose effacacy, the side effects on some of them were far worse than Iclusig. Admittedly this is anechdotal and specific only to my case butit does show that there is muchmore to be learned about this drug and thepotential for market success. The other more disconcerting issue to me personally is that if this drug is no longer available, I have no other treatment options. I do not have the T351I mutation so thathas no bearing on the effacy of the drug. I realize that this is all looked at from a business perspective - at least I, and manynothers like me, demonstrate that there is a potential market for this drug.
    1 Nov 2013, 01:29 PM Reply Like
  • david roper
    , contributor
    Comments (76) | Send Message
     
    loganj2, I am so happy for you. You are exactly the person I was thinking about in my previous post. Other countries do not have a FDA to contend with. Mexico is close by. Continued Good luck, Logan.
    3 Nov 2013, 10:08 AM Reply Like
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