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InterMune, AŞ Message Board

  • ghmemm ghmemm Jan 7, 2009 8:47 PM Flag

    Pirfenidone Outcome Survey

    On the biotech values board on i-hub a survey was added on what you think the results will be. You have to be a member to vote but they have free memberships (I am a free member there).

    Please vote at:
    http://tinyurl.com/6vm7om
    some background info is at:
    http://tinyurl.com/7g45b5

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    • Pirfenidone is BY FAR the bigger risk for the Jan/Feb news flow.
      1. THe company has already stated Phase 2 is planned for 1H '09
      2. Phase 1a and 1b mono therapy data are out and good (maybe not spectacular but certainly good enough).
      3. They ADDED a 6th cohort and said blinded safety data AE's mild to moderate (OK maybe we had a serious AE or two but this is with PEG/Riba) so why would they add a 6th if there was trouble unless it was to try a lower dose.
      4. The INFORM study was started probably around when cohort 5 was ongoing. If there was a safety concern I doubt it would have proceeded.

      Yes there is some risk something unpleasent with the data but at this stage (1B) I think things will be good enough to keep proceeding.

      >> Way I'm figuring, if I was an officer of a little drug development company that would be needing cap infusions in a bad market, I'd want to make all my good announcements in front of lots of analysts, and give my bad results time to cool off before the analysts could do much picking at them.
      Not that I necessarily buy your argument but this is EXACTLY what they are doing the JP Morgan Conference starts next week ITMN presents thursday 1pm PT

      Have a good weekend everyone. I am hoping we also get a comment or two and few questions on Pirfenidone Monday :)

    • I really thought 191 was in the bag. Now I'm more worried about it than about pirfenidone. Way I'm figuring, if I was an officer of a little drug development company that would be needing cap infusions in a bad market, I'd want to make all my good announcements in front of lots of analysts, and give my bad results time to cool off before the analysts could do much picking at them.

    • The feb 20 call has traded another 5000 so far today. Maybe others are thinking an unblinding this weekend with results on Monday. The JPM conference is one of the biggest all year. Would be the perfect setting to either take a victory lap or talk about where the company goes from here if study fails. As I mentioned yesterdy, it is more important to follow the options at this point than the common. The common looks dead, like there is nothing going on at all.

    • ghmemm, nice job on that board, I got a question for you, you wrote that both Tracleer and Letaris are in clinical trials for IPF, can you name some of the drugs that failed in clinical results? I know Actimmune is one. I just hope that IPF isn't a graveyard for biotech companies like lupus has been, melanoma and pancreatic cancers, etc..

      • 1 Reply to duragen
      • I lost my post and don't feel like retyping it all.

        Basically not many have made it to Phase 3 even.
        Some of the failures (some had some signs of benefit) I can think of are Ilhoprost, Gleevec, Enebrel, NAC. Tracleer actually missed but had signs of efficacy in a predifined subgroup (biopsy proven IPF).

    • I have played many large trial results similar to this.It is now well over 2 months since the last patient visit took place. In past experiences, the longer this drags out the more likely the results will be negative. Even though this is a blinded study, the company has full access to patient records. It is a no brainer to be able to tell who received study drug and who didn't. There are side effects to pirf and they these will be noted in patient records. Once you have a good idea who was on drug, it is easy to then plot the results against those who obviously did not get drug. When a company has a good indication of failure then they delay the results. They do the ol sub group analysis looking for some type of positives. Not too long ago I brought this exact issue up regarding altus and their pancreatic insufficiency drug.The trial results were overdue and that raised the red flag. I was able to capitalize on that as results were poor and the stock got crushed. Sure enough though they tried to put a positive spin on a bad outcome by data mining the results. Unfortunately, I still have hope here and I am not able to back up my position with puts as they are outrageous in price. So I will chalk this one up as a learning experience. Do not play these types of situations unless you can hedge.

      • 3 Replies to thesunneyone
      • sunny, if you go back to the Q3 earnings release, they planned on having pirfenidone data in the Jan/Feb timeframe, as far as I now, thats still the target. I would like to see ITMN 191 data ahead of pirf data.

      • I don't recall Altus results being "overdue" and they mentioned that some x-US centers showed no significance they really didn't do much "data mining" if they had actually come up with a theory as to why then I think it would be a fairer accusation. In fact they said the opposite that they saw no reason for the difference.

        If you want to push the theory the company can tell by seeing adverse events on a blinded basis then why not sell now? If you are so worried about Pirfenidone results then why not just sell like everyone else? Surely you would lose less selling now then on negative results?

        The market was down yesterday big and for comparison IDIX was down about the same percentage wise. People are nervous, anxious and risk averse this is a risky outcome no doubt.

        If we don't have results by next week I think a good format of Q&A at JP Morgan should make Dan be more forthcoming with at least when we will get results.

      • sunny, I understand where your coming from, now that the stock has hit an alltime low, 9.07 yesterday, I'm almost dreading the press release for the pirfenidone trial results. I woke up this morning and check the newsflow with one eye open, I could just feel the failure coming, but I am still long. I sure hope Intermune is the next Myogen and not the next Altus.

 
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